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Clinical Trial Results:
A Randomized, Multicenter, Open-Label Cross-Over Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non–Small Cell Lung Cancer

Summary
EudraCT number	2021-004067-28
Trial protocol	IT ES FI LV
Global end of trial date	25 Oct 2024

Results information
Results version number	v2(current)
This version publication date	31 Oct 2025
First version publication date	06 Nov 2024
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

MO43576

ISRCTN number

US NCT number

NCT05171777

WHO universal trial number (UTN)

Sponsor organisation name

F. Hoffmann-La Roche AG

Sponsor organisation address

Grenzacherstrasse 124, Basel, Switzerland, CH-4058

Public contact

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com

Scientific contact

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

25 Oct 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

25 Oct 2024

Was the trial ended prematurely?

Main objective of the trial

The main purpose of the study was to evaluate participant preference for atezolizumab subcutaneous (SC) administration compared with atezolizumab intravenous (IV).

Protection of trial subjects

All study participants were required to read and sign an Informed Consent Form.

Background therapy

Evidence for comparator

Actual start date of recruitment

04 Apr 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 21

Country: Number of subjects enrolled

Chile: 1

Country: Number of subjects enrolled

Costa Rica: 8

Country: Number of subjects enrolled

United States: 8

Country: Number of subjects enrolled

Finland: 8

Country: Number of subjects enrolled

Italy: 20

Country: Number of subjects enrolled

Latvia: 20

Country: Number of subjects enrolled

Poland: 28

Country: Number of subjects enrolled

Spain: 39

Country: Number of subjects enrolled

Korea, Democratic People's Republic of: 14

Country: Number of subjects enrolled

Brazil: 4

Country: Number of subjects enrolled

Canada: 8

Worldwide total number of subjects

179

EEA total number of subjects

115

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

102

85 years and over

Subject disposition

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Recruitment details

Participants took part in the study across 37 investigative sites in 12 countries (Spain, Brazil, Finland, Italy, United States, Argentina, Canada, Republic of Korea, Costa Rica, Latvia, Poland, and Chile) from 04 April 2022 to 25 October 2024.

Screening details

A total of 179 participants with non-small cell lung cancer (NSCLC) were randomized in 1:1 ratio to Arm A (atezolizumab IV followed by atezolizumab SC) or Arm B (atezolizumab SC followed by atezolizumab IV). The study consists of two periods: Treatment Crossover Period, and Treatment Continuation Period.

Period 1 title

Treatment Crossover Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Crossover Atezolizumab IV/SC

Arm description

Participants were administered atezolizumab, IV infusion, 1200 milligrams (mg), every 3 weeks (Q3W) for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.

Arm type

Experimental

Investigational medicinal product name

Atezolizumab IV

Investigational medicinal product code

RO5541267

Other name

Tecentriq, MPDL3280A

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of Cycles 1 to 3 (each cycle 21-day) or until loss of clinical benefit.

Investigational medicinal product name

Atezolizumab SC

Investigational medicinal product code

RO5541267

Other name

Tecentriq, MPDL3280A

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Atezolizumab, 1875 mg, Q3W SC on Day 1 of Cycles 4 to 6 (each cycle 21-day) or until loss of clinical benefit.

Crossover Atezolizumab SC/IV

Arm description

Arm type

Experimental

Investigational medicinal product name

Atezolizumab IV

Investigational medicinal product code

RO5541267

Other name

Tecentriq, MPDL3280A

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of Cycles 4 to 6 (each cycle 21-day) or until loss of clinical benefit.

Investigational medicinal product name

Atezolizumab SC

Investigational medicinal product code

RO5541267

Other name

Tecentriq, MPDL3280A

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Atezolizumab, 1875 mg, Q3W SC on Day 1 of Cycles 1 to 3 (each cycle 21-day) or until loss of clinical benefit.

Number of subjects in period 1	Crossover Atezolizumab IV/SC	Crossover Atezolizumab SC/IV
Started	89	90
Completed	55	60
Not completed	34	30
Consent withdrawn by subject	4	4
Disease Relapse	1	-
Physician decision	-	1
Adverse Event	9	6
Death	5	5
Progressive Disease	14	10
Symptomatic Deterioration	-	1
Reason not Specified	1	1
Protocol deviation	-	2

Period 2 title

Treatment Continuation Period

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Continuation Atezolizumab IV

Arm description

After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.

Arm type

Experimental

Investigational medicinal product name

Atezolizumab IV

Investigational medicinal product code

RO5541267

Other name

Tecentriq, MPDL3280A

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle from cycle 6 for up to 16 cycles or until loss of clinical benefit.

Continuation Atezolizumab SC

Arm description

After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.

Arm type

Experimental

Investigational medicinal product name

Atezolizumab SC

Investigational medicinal product code

RO5541267

Other name

Tecentriq, MPDL3280A

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Atezolizumab, 1875 mg, Q3W SC on Day 1 of each 21-day cycle from cycle 6 for up to 16 cycles or until loss of clinical benefit.

Number of subjects in period 2	Continuation Atezolizumab IV	Continuation Atezolizumab SC
Started	26	89
Completed	11	32
Not completed	15	57
Disease Relapse	1	-
Consent withdrawn by subject	-	6
Physician decision	-	4
Study Ended by Sponsor	4	15
Adverse Event	3	6
Death	1	3
Progressive Disease	6	20
Symptomatic Deterioration	-	2
Lack of efficacy	-	1

Baseline characteristics

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Reporting group title

Crossover Atezolizumab IV/SC

Reporting group description

Reporting group title

Crossover Atezolizumab SC/IV

Reporting group description

Reporting group values	Crossover Atezolizumab IV/SC	Crossover Atezolizumab SC/IV	Total
Number of subjects	89	90	179
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	66.3 ( 9.2 )	67.7 ( 9.4 )	-
Sex: Female, Male
Units: participants
Female	28	32	60
Male	61	58	119
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	1	2	3
Asian	5	8	13
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	0	0	0
White	75	74	149
More than one race	0	0	0
Unknown or Not Reported	7	6	13
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	20	18	38
Not Hispanic or Latino	55	62	117
Unknown or Not Reported	14	10	24

End points

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Reporting group title

Crossover Atezolizumab IV/SC

Reporting group description

Reporting group title

Crossover Atezolizumab SC/IV

Reporting group description

Reporting group title

Continuation Atezolizumab IV

Reporting group description

Reporting group title

Continuation Atezolizumab SC

Reporting group description

After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.

Subject analysis set title

Atezolizumab IV/SC (Cycles 1 to 3)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for Cycles 1 to 3 (cycle length=21 days) of the Treatment Crossover Period.

Subject analysis set title

Atezolizumab IV/SC (Cycles 4 to 6)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for Cycles 4 to 6 (cycle length=21 days) of the Treatment Crossover Period.

Subject analysis set title

Atezolizumab SC/IV (Cycles 1 to 3)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for Cycles 1 to 3 (cycle length=21 days) of the Treatment Crossover Period.

Subject analysis set title

Atezolizumab SC/IV (Cycles 4 to 6)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for Cycles 4 to 6 (cycle length=21 days) of the Treatment Crossover Period.

Subject analysis set title

Atezolizumab IV/SC

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. HCPs who prepared and/or administered the IV/SC formulations completed the HCPQ questionnaire.

Subject analysis set title

Atezolizumab SC/IV

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. HCPs who prepared and/or administered the IV/SC formulations completed the HCPQ questionnaire.

Subject analysis set title

Atezolizumab

Subject analysis set type

Full analysis

Subject analysis set description

Participants received atezolizumab IV, 1200 mg and/or SC, 1875 mg Q3W up to Cycle 16 in Treatment Crossover Period and Treatment Continuation Period for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.

Subject analysis set title

Crossover Atezolizumab IV

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants who were administered atezolizumab, IV infusion, 1200 mg, Q3W in Cycles 1 to 3 or Cycles 4 to 6 (cycle length=21 days), depending on the sequence (IV/SC or SC/IV) they were assigned in the Treatment Crossover Period are reported in this arm.

Subject analysis set title

Crossover Atezolizumab SC

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants who were administered atezolizumab, SC injections, 1875 mg, Q3W for Cycles 1 to 3 or Cycles 4 to 6 (cycle length=21 days), depending on the sequence (IV/SC or SC/IV) they were assigned in the Treatment Crossover Period are reported in this arm.

Subject analysis set title

Continuation Atezolizumab IV

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.

Subject analysis set title

Continuation Atezolizumab SC

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.

Subject analysis set title

All Participants

Subject analysis set type

Per protocol

Subject analysis set description

Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.

Primary: Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ)

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End point title

Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ) ^[1]

End point description

Participants preference was assessed based on Question 1 (Q1) of PPQ. Q1: All things considered, which route of administration did you prefer? asks participants to report their preference for route of administration (IV/SC/preference). A point estimate with associated 95% CI for percentage of participants who preferred atezolizumab SC was calculated. Participants experiencing any of the following events: treatment withdrawal before eligibility for PPQ, or death without answering Q1 of PPQ, or treatment not started, were excluded from analysis set. Participants who answered Q1 of PPQ without having at least 2 consecutive administrations of treatment with each administration modality (SC & IV) were excluded from analysis. As planned participant preference was presented by overall (all participants) & by randomized treatment sequence using Full Analysis Set (FAS). FAS=all randomized participants. Number analyzed=number of participants who answered Q1 of PPQ. Percentages are rounded off.

End point type

Primary

End point timeframe

Cycle 6 Day 1 (cycle length=21 days)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive statistics were planned for this endpoint.

End point values	Crossover Atezolizumab IV/SC	Crossover Atezolizumab SC/IV	All Participants
Number of subjects analysed	60	63	123
Units: percentage of participants
number (confidence interval 95%)	71.67 (58.56 to 82.55)	69.84 (56.98 to 80.77)	70.73 (61.85 to 78.59)

No statistical analyses for this end point

Secondary: Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire – Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)

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End point title

Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire – Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)

End point description

TASQ=12-item, participant-reported questionnaire measuring the impact of each mode of treatment administration (TASQ-IV=IV treatment & TASQ-SC=SC treatment) on 5 domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, & Satisfaction. TASQ-IV/-SC was administered at treatment Cycles 3 & 6 according to order of treatment received per arm during Crossover Period. Participants satisfaction was assessed based on the Q1 of TASQ-IV/SC which asks participants about their satisfaction with respect to route of administration (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, participant didn’t answer question). TASQ- IV (Q1-How satisfied/dissatisfied were you with IV infusion?) & TASQ- SC (How satisfied or dissatisfied were you with SC injection?). FAS included all randomized participants. Number analyzed=number of participants with data available for analysis. n=number of participants who answered Q1 of TASQ IV/SC.

End point type

Secondary

End point timeframe

Cycles 3 Day 1 and Cycle 6 Day 1 (cycle length=21 days)

End point values	Crossover Atezolizumab IV/SC	Crossover Atezolizumab SC/IV
Number of subjects analysed	74	71
Units: participants
TASQ- IV-Very Satisfied(n=74, 59)	25	10
TASQ-IV-Satisfied(n=74, 59)	31	34
TASQ-IV-Neither Satisfied/Dissatisfied(n=74,59)	17	11
TASQ-IV-Dissatisfied(n=74, 59)	1	1
TASQ-IV-Very Dissatisfied(n=74, 59)	0	3
TASQ-IV-Participant didn't Answer(n=74,59)	0	0
TASQ-SC-Very Satisfied(n=56, 71)	22	30
TASQ-SC-Satisfied(n=56, 71)	21	36
TASQ-SC-Neither Satisfied/Dissatisfied(n=56,71)	9	5
TASQ-SC-Dissatisfied(n=56, 71)	3	0
TASQ-SC-Very Dissatisfied(n=56, 71)	1	0
TASQ-SC-Participant didn't Answer(n=56,71)	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period

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End point title

Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period

End point description

At Cycle 6, Day 1, participants were expected to select the route of study treatment administration (SC or IV) they would like to receive during the Treatment Continuation Period (starting at Cycle 7). Percentage of participants who chose SC administration have been reported here. FAS included all randomized participants. Number analyzed is the number of participants with data available for analysis. Percentages have been rounded off.

End point type

Secondary

End point timeframe

Cycle 6 Day 1 (Cycle length=21 days)

End point values	Crossover Atezolizumab IV/SC	Crossover Atezolizumab SC/IV
Number of subjects analysed	55	60
Units: percentage of participants
number (not applicable)	78.2	76.7

No statistical analyses for this end point

Secondary: Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of HCPQs – Drug Preparation Area

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End point title

Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of HCPQs – Drug Preparation Area

End point description

The HCPQ- Drug Preparation Area Question 1 was completed by the HCPs within the pharmacy/drug preparation area where atezolizumab IV reconstitution or atezolizumab SC was prepared before the actual drug administration took place. The HCPQs were completed for every participant at each treatment cycle (Cycles 1–6, i.e., 3 cycles of atezolizumab IV followed by 3 cycles of atezolizumab SC or vice versa) of the treatment cross-over period. HCPs responded to the following parts of Question 1 that sought to evaluate the amount of time it took to prepare the IV infusion/SC injection of atezolizumab: "How long (in minutes) did it take to prepare the treatment for use?". Number analyzed included HCPs who completed Question 1 of the survey. "n"=number of HCPs who completed Question 1 of the survey at the specified treatment cycles.

End point type

Secondary

End point timeframe

Day 1 of Cycles 1 to 6 (cycle length= 21 days)

End point values	Atezolizumab IV/SC	Atezolizumab SC/IV
Number of subjects analysed	84	83
Units: minutes
median (full range (min-max))
Cycle 1 (n=84,83)	5.0 (1 to 40)	5.0 (1 to 45)
Cycle 2 (n=80,80)	5.0 (1 to 40)	5.0 (1 to 35)
Cycle 3 (n=72,74)	5.0 (1 to 45)	4.5 (1 to 40)
Cycle 4 (n=67,71)	5.0 (1 to 35)	5.0 (1 to 50)
Cycle 5 (n=62,64)	5.0 (1 to 35)	5.0 (1 to 59)
Cycle 6 (n=56,60)	5.0 (1 to 35)	5.0 (1 to 36)

No statistical analyses for this end point

Secondary: Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ – Drug Preparation Area

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End point title

Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ – Drug Preparation Area

End point description

HCPs within pharmacy/drug preparation area responded to HCPQ-Drug Preparation Area Q2 at Cycle 6: If all IV infusions are switched to SC, please indicate how strongly you agree/disagree with these statements: a=Staff will have increased availability for other tasks in pharmacy;b=Administrative procedures around atezolizumab (ATZ) SC will require less time;c=ATZ SC formulations will provide more flexibility for staff in managing their workload; d=Due to ready-to-use ATZ SC formulations, potential dosing errors will be avoided;e=Due to ready-to-use ATZ SC formulations, there will be less drug wastage;f=Without having to reconstitute the drug, less storage space for ATZ SC related supplies will be required in the pharmacy;g=Preparation procedures & associated time. staff time commitment will be reduced;h=It will ease drug administration for participants with difficult venous access. Number analyzed=HCPs who completed Q2 of survey at treatment Cycle 6. Percentages have been rounded off.

End point type

Secondary

End point timeframe

Cycle 6 Day 1 (cycle length=21 days)

End point values	Atezolizumab IV/SC	Atezolizumab SC/IV
Number of subjects analysed	57	60
Units: percentage of HCPs
number (not applicable)
a=Strongly Disagree	7.0	10.0
a=Disagree	7.0	0
a=Neutral	21.1	31.7
a=Agree	24.6	20.0
a=Strongly Agree	31.6	25.0
a=Not Applicable	3.5	1.7
a=Missing	5.3	11.7
b=Strongly Disagree	7.0	10.0
b=Disagree	14.0	8.3
b=Neutral	29.8	28.3
b=Agree	12.3	18.3
b=Strongly Agree	24.6	16.7
b=Not Applicable	7.0	6.7
b=Missing	5.3	11.7
c=Strongly Disagree	0	0
c=Disagree	8.8	0
c=Neutral	29.8	53.3
c=Agree	26.3	18.3
c=Strongly Agree	26.3	15.0
c=Not Applicable	3.5	1.7
c=Missing	5.3	11.7
d=Strongly Disagree	12.3	20.0
d=Disagree	12.3	3.3
d=Neutral	22.8	30.0
d=Agree	15.8	18.3
d=Strongly Agree	28.1	15.0
d=Not Applicable	3.5	1.7
d=Missing	5.3	11.7
e=Strongly Disagree	1.8	0
e=Disagree	19.3	11.7
e=Neutral	14.0	26.7
e=Agree	29.8	38.3
e=Strongly Agree	26.3	10.0
e=Not Applicable	3.5	1.7
e=Missing	5.3	11.7
f=Strongly Disagree	0	1.7
f=Disagree	10.5	5.0
f=Neutral	33.3	46.7
f=Agree	21.1	20.0
f=Strongly Agree	26.3	8.3
f=Not Applicable	3.5	6.7
f=Missing	5.3	11.7
g=Strongly Disagree	5.3	11.7
g=Disagree	5.3	1.7
g=Neutral	26.3	36.7
g=Agree	26.3	21.7
g=Strongly Agree	28.1	15.0
g=Not Applicable	3.5	1.7
g=Missing	5.3	11.7
h=Strongly Disagree	0	0
h=Disagree	0	0
h=Neutral	10.5	15.0
h=Agree	40.4	38.3
h=Strongly Agree	28.1	25.0
h=Not Applicable	15.8	10.0
h=Missing	5.3	11.7

No statistical analyses for this end point

Secondary: Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area

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End point title

Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area

End point description

HCPs who prepared study treatment within the pharmacy/drug preparation area responded at Cycle 6 of the Treatment Crossover Period to the following HCPQ-Drug Preparation Area Questions 3 and 4: "Looking back over the Atezolizumab treatment sessions, please indicate based on your opinion which administration method: Q3. Was quickest from start to end of preparation to finish of administration (excluding observation period)?; Q4. Required less resource use for preparation and administration, for example nursing time, facility costs, equipment etc?" The four available response options were: Atezolizumab IV, Atezolizumab SC, No Difference, and Missing. Number analyzed included HCPs who completed Questions 3 and 4 of the survey at treatment Cycle 6. Percentages have been rounded off.

End point type

Secondary

End point timeframe

Cycle 6 Day 1 (cycle length= 21 days)

End point values	Atezolizumab IV/SC	Atezolizumab SC/IV
Number of subjects analysed	57	60
Units: percentage of HCPs
number (not applicable)
Q3=Atezolizumab SC	71.9	58.3
Q3=Atezolizumab IV	0	0
Q3=No Difference	17.5	21.7
Q3= Missing	10.5	20.0
Q4=Atezolizumab SC	64.9	60.0
Q4=Atezolizumab IV	3.5	0
Q4=No Difference	21.1	20.0
Q4=Missing	10.5	20.0

No statistical analyses for this end point

Secondary: Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs – Treatment Room

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End point title

Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs – Treatment Room

End point description

HCPQ-Treatment Room Q1 was completed per cycle of Crossover Period by HCPs who administered treatment, responded to parts of Q1 that evaluates amount of time it took to complete activities related to treatment administration: If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided(central venous catheter(CVC),peripherally inserted central catheter(PICC),peripheral vein cannulation(PVC))&how long(mins)this took to set up(only for participants receiving IV treatment)?How long(mins)did it take to administer treatment,i.e.total infusion duration?How long(mins)was the participant in treatment room for in total? 99999=0 participants were analyzed at specified cycle. Durations with non-zero HCPs responders have been reported here. Number analyzed=HCPs who completed Q1 of survey. For the questions related to IV access, n=HCP responders for participants who required new IV access at a specified cycle & who completed Q1 of survey.

End point type

Secondary

End point timeframe

Day 1 of Cycles 1 to 6 (cycle length=21 days)

End point values	Atezolizumab IV/SC	Atezolizumab SC/IV
Number of subjects analysed	87	86
Units: minutes
median (full range (min-max))
Cycle 1:Duration of CVC set up?(n=1,0)	5.0 (5 to 5)	99999 (99999 to 99999)
Cycle 1:Duration of PICC set up?(n=3,0)	30.0 (8 to 30)	99999 (99999 to 99999)
Cycle 1:Duration of PVC set up?(n=62,0)	5.0 (1 to 70)	99999 (99999 to 99999)
Cycle 1:How Long it Took to Administer?(n=85,86)	60.0 (10 to 120)	8.0 (5 to 75)
Cycle1:How Long was Participant in Room?(n=85,86)	92.0 (35 to 390)	55.0 (10 to 260)
Cycle 2:Duration of PICC set up?(n=3,0)	30.0 (5 to 35)	99999 (99999 to 99999)
Cycle 2: Duration of PVC set up?(n=52,0)	5.0 (3 to 10)	99999 (99999 to 99999)
Cycle 2:How Long it Took to Administer?(n=77,79)	30.0 (13 to 90)	6.0 (3 to 30)
Cycle2: How Long was Participant in Room?(n=87,86)	75.0 (33 to 330)	41.0 (10 to 238)
Cycle 3:Duration of CVC set up? (n=1,0)	61.0 (61 to 61)	99999 (99999 to 99999)
Cycle 3: Duration of PICC set up?(n=4,0)	17.5 (5 to 30)	99999 (99999 to 99999)
Cycle 3: Duration of PVC set up?(n=46,0)	5.0 (1 to 40)	99999 (99999 to 99999)
Cycle3:How Long it Took to Administer?(n=72,75)	30.0 (20 to 66)	6.0 (3 to 15)
Cycle3:How Long was Participant in Room?(n=72,75)	70.0 (35 to 323)	49.0 (5 to 128)
Cycle 4:Duration of CVC set up?(n=0,1)	99999 (99999 to 99999)	10.0 (10 to 10)
Cycle 4: Duration of PICC set up?(n=0,5)	99999 (99999 to 99999)	30.0 (10 to 60)
Cycle 4:Duration of PVC set up?(n=0,49)	99999 (99999 to 99999)	5.0 (1 to 70)
Cycle 4: How Long it Took to Administer? (n=68,70)	8.0 (5 to 73)	60.0 (15 to 90)
Cycle4:How Long was Participant in Room?(n=87,86)	45.0 (10 to 320)	97.0 (20 to 360)
Cycle 5:Duration of CVC set up? (n=0,1)	99999 (99999 to 99999)	5.0 (5 to 5)
Cycle 5: Duration of PICC set up?(n=0,6)	99999 (99999 to 99999)	22.5 (7 to 51)
Cycle 5: Duration of PVC set up?(n=0,46)	99999 (99999 to 99999)	5.0 (1 to 65)
Cycle 5:How Long it Took to Administer?(n=61,65)	6.0 (1 to 15)	30.0 (8 to 60)
Cycle5:How Long was Participant Room? (n=61,64)	35.0 (8 to 200)	71.0 (30 to 360)
Cycle 6: Duration of PICC set up? (n=0,6)	99999 (99999 to 99999)	12.5 (5 to 30)
Cycle 6: Duration of PVC set up?(n=0,40)	99999 (99999 to 99999)	5.0 (1 to 33)
Cycle 6:How Long it Took to Administer? (n=58,60)	7.0 (1 to 35)	30.0 (8 to 63)
Cycle6:How Long was Participant in Room? (n=58,60)	37.5 (9 to 240)	61.0 (14 to 380)

No statistical analyses for this end point

Secondary: Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ – Treatment Room

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End point title

Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ – Treatment Room

End point description

HCPs who administered treatment responded to Q2: If all IV are switched to SC, please indicate how strongly you agree/disagree with following statements: a=Participants will be moved outside of infusion unit (IU) to receive SC injections; b=ATZ SC route will allow more flexible treatment scheduling; c=More participants will be treated in IU; d=Waiting list for IV treatment at IU will be reduced; e=Staff resources will be redistributed to other departments of hospital(i.e. less staffing required within IU); f=There will still be sufficient interaction time between HCP &participants (e.g. for participant education); g=Staff will spend more time for further professional education/development; h=Staff will dedicate more time to attending to administrative tasks for participants; i=Participants will spend less time in care unit; j=Administration by ATZ SC injection is preferred by participants. Number analyzed included HCPs who completed Q 2 of the survey at treatment Cycle 6.

End point type

Secondary

End point timeframe

Cycle 6 Day 1 (cycle length=21 days)

End point values	Atezolizumab IV/SC	Atezolizumab SC/IV
Number of subjects analysed	58	61
Units: percentage of HCPs
number (not applicable)
a=Strongly Disagree	13.8	11.5
a=Disagree	15.5	23.0
a=Neutral	1.7	6.6
a=Agree	27.6	23.0
a=Strongly Agree	17.2	14.8
a=Not Applicable	10.3	1.6
a=Missing	13.8	19.7
b=Strongly Disagree	5.3	1.6
b=Disagree	19.0	14.8
b=Neutral	10.3	21.3
b=Agree	22.4	21.3
b=Strongly Agree	27.6	21.3
b=Not Applicable	1.7	0
b=Missing	13.8	19.7
c=Strongly Disagree	5.2	0
c=Disagree	15.5	16.4
c=Neutral	12.1	23.0
c=Agree	25.9	26.2
c=Strongly Agree	27.6	14.8
c=Not Applicable	0	0
c=Missing	13.8	19.7
d=Strongly Disagree	6.9	1.6
d=Disagree	5.2	6.6
d=Neutral	25.9	31.1
d=Agree	19.0	23.0
d=Strongly Agree	27.6	18.0
d=Not Applicable	1.7	0
d=Missing	13.8	19.7
e=Strongly Disagree	13.8	11.5
e=Disagree	8.6	14.8
e=Neutral	27.6	26.2
e=Agree	10.3	11.5
e=Strongly Agree	19.0	13.1
e=Not Applicable	6.9	3.3
e=Missing	13.8	19.7
f=Strongly Disagree	0	0
f=Disagree	17.2	11.5
f=Neutral	17.2	32.8
f=Agree	22.4	16.4
f=Strongly Agree	29.3	19.7
f=Not Applicable	0	0
f=Missing	13.8	19.7
g=Strongly Disagree	6.9	1.6
g=Disagree	12.1	11.5
g=Neutral	27.6	27.9
g=Agree	13.8	24.6
g=Strongly Agree	25.9	14.8
g=Not Applicable	0	0
g=Missing	13.8	19.7
h=Strongly Disagree	6.9	0
h=Disagree	17.2	24.6
h=Neutral	15.5	13.1
h=Agree	24.1	29.5
h=Strongly Agree	20.7	13.1
h=Not Applicable	1.7	0
h=Missing	13.8	19.7
i=Strongly Disagree	1.7	1.6
i=Disagree	5.2	4.9
i=Neutral	8.6	14.8
i=Agree	37.9	27.9
i=Strongly Agree	32.8	31.1
i=Not Applicable	0	0
i=Missing	13.8	19.7
j=Strongly Disagree	1.7	1.6
j=Disagree	0	3.3
j=Neutral	20.7	21.3
j=Agree	31.0	27.9
j=Strongly Agree	31.0	26.2
j=Not Applicable	1.7	0
j=Missing	13.8	19.7

No statistical analyses for this end point

Secondary: Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room

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End point title

Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room

End point description

HCPs who administered study treatment responded at Cycle 6 of the Treatment Cross-over Period to the following HCPQ-treatment room Questions 3 to 7: "Looking back over the atezolizumab treatment sessions, please indicate based on your opinion which administration method: Q3. Which method was most convenient for the participant? Q4. Which method was best for optimizing participant care in your centre? Q5. Which method took the least time from start to finish of administration? Q6. Which method required the least resource use for administration? Q7. Which method was preferred by participants? The five available response options were: Atezolizumab SC, Atezolizumab IV, No Difference, Unsure and Missing. Number analyzed included HCPs who completed Questions 3 to 7 of the survey at treatment Cycle 6. Percentages have been rounded off.

End point type

Secondary

End point timeframe

Cycle 6 Day 1 (cycle length=21 days)

End point values	Atezolizumab IV/SC	Atezolizumab SC/IV
Number of subjects analysed	58	61
Units: percentage of HCPs
number (not applicable)
Q3=Atezolizumab SC	72.4	63.9
Q3=Atezolizumab IV	5.2	10.1
Q3=No Difference	6.9	8.4
Q3=Unsure	1.7	3.3
Q3= Missing	13.8	14.4
Q4=Atezolizumab SC	55.2	39.3
Q4=Atezolizumab IV	6.9	1.5
Q4=No Difference	20.7	31.1
Q4=Unsure	3.4	1.6
Q4=Missing	13.8	16.4
Q5=Atezolizumab SC	67.2	52.5
Q5=Atezolizumab IV	0	3.3
Q5=No Difference	17.2	27.9
Q5=Unsure	0	0
Q5=Missing	15.5	16.4
Q6=Atezolizumab SC	63.8	50.8
Q6=Atezolizumab IV	3.4	1.6
Q6=No Difference	19.0	31.1
Q6=Unsure	0	0
Q6=Missing	13.8	16.4
Q7=Atezolizumab SC	63.8	52.5
Q7=Atezolizumab IV	10.3	14.8
Q7=No Difference	3.4	1.6
Q7=Unsure	8.6	14.8
Q7=Missing	13.8	16.4

No statistical analyses for this end point

Secondary: Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room

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End point title

Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room

End point description

HCPs who administered study treatment responded at Cycle 6 of the Treatment Cross-over Period to the following HCPQ-treatment room Question 8: How frequently would you offer or recommend atezolizumab SC administration to your participants in the future? The four available response options were Always, Sometimes, Never and Missing. Number analyzed included HCPs who completed Question 8 of the survey at treatment Cycle 6. Percentages have been rounded off.

End point type

Secondary

End point timeframe

Cycle 6 Day 1 (cycle length= 21 days)

End point values	Atezolizumab IV/SC	Atezolizumab SC/IV
Number of subjects analysed	58	61
Units: percentage of HCPs
number (not applicable)
Q8=Always	41.4	31.1
Q8=Sometimes	34.5	37.7
Q8=Never	10.3	14.8
Q8=Missing	13.8	16.4

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC-QLQ-C30)

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End point title

Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC-QLQ-C30)

End point description

EORTC QLQ-C30=30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, and pain), GHS & QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) with a recall period of previous week. Functioning items are scored on 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0-100, with high score=better functioning & the data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of items completed, it was considered as missing. FAS=all randomized participants. Number analyzed=participants with data available for analysis. n=participants with data available for analysis at specified timepoint. 9999=no participants were analyzed at this timepoint.

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	75.00 ( 19.79 )	9999 ( 9999 )	72.09 ( 20.10 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	-0.46 ( 19.62 )	9999 ( 9999 )	-2.01 ( 16.00 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	0.00 ( 16.19 )	9999 ( 9999 )	-1.60 ( 16.74 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,76)	9999 ( 9999 )	-2.22 ( 13.85 )	9999 ( 9999 )	0.03 ( 15.39 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	0.91 ( 19.55 )	9999 ( 9999 )	2.06 ( 16.64 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	-5.10 ( 19.93 )	9999 ( 9999 )	-0.43 ( 17.98 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	0.48 ( 16.22 )	9999 ( 9999 )	1.03 ( 15.77 )
Change at End of Treatment (n=12,10,24,76)	-13.75 ( 28.39 )	-8.06 ( 21.26 )	-14.67 ( 25.49 )	-3.92 ( 21.67 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30

End point description

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	77.46 ( 25.15 )	9999 ( 9999 )	73.73 ( 27.86 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	1.16 ( 29.25 )	9999 ( 9999 )	-1.33 ( 21.88 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	-2.01 ( 26.13 )	9999 ( 9999 )	-1.64 ( 24.10 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	-8.33 ( 18.39 )	9999 ( 9999 )	-5.41 ( 26.00 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	-6.82 ( 23.94 )	9999 ( 9999 )	-2.03 ( 24.20 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	-6.86 ( 21.29 )	9999 ( 9999 )	-1.60 ( 26.52 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	-2.38 ( 14.41 )	9999 ( 9999 )	-2.74 ( 26.84 )
Change at End of Treatment (n=12,10,24,77)	-16.67 ( 43.81 )	-9.72 ( 24.04 )	-15.00 ( 24.15 )	-8.01 ( 25.88 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30

End point description

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	79.48 ( 22.43 )	9999 ( 9999 )	75.98 ( 23.44 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	2.62 ( 20.52 )	9999 ( 9999 )	0.89 ( 16.47 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	0.77 ( 17.68 )	9999 ( 9999 )	4.10 ( 23.30 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	-3.47 ( 22.64 )	9999 ( 9999 )	2.56 ( 15.84 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	-3.03 ( 26.92 )	9999 ( 9999 )	4.37 ( 16.91 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	0.98 ( 22.61 )	9999 ( 9999 )	3.46 ( 19.00 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	-2.98 ( 23.02 )	9999 ( 9999 )	0.37 ( 17.49 )
Change at End of Treatment (n=12,10,24,77)	-6.71 ( 16.98 )	-8.33 ( 28.45 )	-6.67 ( 21.08 )	-5.05 ( 18.16 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30

End point description

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	87.31 ( 21.74 )	9999 ( 9999 )	85.69 ( 19.78 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	2.31 ( 17.31 )	9999 ( 9999 )	-5.56 ( 19.05 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	-5.75 ( 18.87 )	9999 ( 9999 )	-1.09 ( 20.15 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	-4.17 ( 13.23 )	9999 ( 9999 )	-2.16 ( 19.37 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	-5.30 ( 11.94 )	9999 ( 9999 )	-0.41 ( 17.76 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	-11.76 ( 21.86 )	9999 ( 9999 )	-1.14 ( 21.21 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	-7.14 ( 12.60 )	9999 ( 9999 )	-2.99 ( 21.11 )
Change at End of Treatment (n=12,10,24,77)	-6.94 ( 25.08 )	-5.56 ( 23.40 )	3.33 ( 17.21 )	-7.36 ( 22.70 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30

End point description

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	82.95 ( 23.02 )	9999 ( 9999 )	82.35 ( 22.76 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	3.70 ( 23.61 )	9999 ( 9999 )	-3.56 ( 21.10 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	-2.87 ( 24.81 )	9999 ( 9999 )	-1.91 ( 22.38 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	-6.25 ( 27.72 )	9999 ( 9999 )	0.22 ( 21.71 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	-3.79 ( 27.18 )	9999 ( 9999 )	-0.20 ( 25.32 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	-3.92 ( 17.21 )	9999 ( 9999 )	-0.46 ( 23.57 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	-5.95 ( 24.11 )	9999 ( 9999 )	0.50 ( 19.67 )
Change at End of Treatment (n=12,10,24,77)	-12.50 ( 46.13 )	-15.28 ( 24.53 )	-15.00 ( 29.87 )	-4.98 ( 27.84 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30

End point description

EORTC QLQ-C30=30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, and pain), GHS & QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) with a recall period of previous week. Symptoms items are scored on 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0-100, with high score=worst symptoms & the data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of items completed, it was considered as missing. FAS=all randomized participants. Number analyzed=participants with data available for analysis. n=participants with data available for analysis at specified timepoint. 9999=no participants were analyzed at this timepoint.

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	30.81 ( 25.81 )	9999 ( 9999 )	36.08 ( 26.33 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	0.15 ( 26.67 )	9999 ( 9999 )	-1.63 ( 20.32 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	4.41 ( 25.06 )	9999 ( 9999 )	1.46 ( 21.13 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	2.78 ( 18.02 )	9999 ( 9999 )	1.59 ( 23.27 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	3.03 ( 21.74 )	9999 ( 9999 )	-0.14 ( 21.63 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	4.58 ( 15.24 )	9999 ( 9999 )	3.96 ( 26.02 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	5.56 ( 20.32 )	9999 ( 9999 )	1.00 ( 26.64 )
Change at End of Treatment (n=12,10,24,77)	6.48 ( 24.37 )	1.39 ( 27.86 )	4.44 ( 24.68 )	7.65 ( 24.13 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30

End point description

EORTC QLQ-C30=30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, and pain), GHS & QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) with a recall period of previous week. Symptom items are scored on 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0-100, with high score=worst symptoms & the data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of items completed, it was considered as missing. FAS=all randomized participants. Number analyzed=participants with data available for analysis. n=participants with data available for analysis at specified timepoint. 9999=no participants were analyzed at this timepoint.

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	5.30 ( 13.50 )	9999 ( 9999 )	5.88 ( 14.48 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	2.31 ( 15.65 )	9999 ( 9999 )	1.56 ( 18.21 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	2.01 ( 12.90 )	9999 ( 9999 )	3.01 ( 14.11 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	4.86 ( 9.17 )	9999 ( 9999 )	-0.65 ( 9.15 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	3.79 ( 10.20 )	9999 ( 9999 )	1.02 ( 9.57 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	0.98 ( 4.04 )	9999 ( 9999 )	0.46 ( 14.16 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	1.19 ( 4.45 )	9999 ( 9999 )	0.75 ( 13.11 )
Change at End of Treatment (n=11,10,24,77)	-3.03 ( 16.36 )	6.94 ( 18.33 )	6.67 ( 23.83 )	1.73 ( 12.56 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30

End point description

EORTC QLQ-C30=30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, and pain), GHS & QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) with a recall period of previous week. Symptom items are scored on 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0-100, with high score=worst symptoms & the data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of items completed, it was considered as missing. FAS=all randomized participants. Number analyzed=participants with data available for analysis. n=participants with data available for analysis at specified timepoint. 9999=no participants were analyzed at this timepoint.

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	22.16 ( 25.23 )	9999 ( 9999 )	29.22 ( 30.74 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	0.93 ( 22.88 )	9999 ( 9999 )	-3.56 ( 26.47 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	4.02 ( 23.22 )	9999 ( 9999 )	-1.09 ( 25.43 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	4.17 ( 28.34 )	9999 ( 9999 )	1.52 ( 28.89 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	3.79 ( 32.50 )	9999 ( 9999 )	-1.22 ( 26.42 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	7.84 ( 35.90 )	9999 ( 9999 )	1.14 ( 25.81 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	4.76 ( 32.31 )	9999 ( 9999 )	1.24 ( 28.32 )
Change at End of Treatment (n=12,10,24,77)	12.50 ( 43.30 )	18.06 ( 33.66 )	-10.00 ( 28.54 )	6.28 ( 30.35 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30

End point description

EORTC QLQ-C30=30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, and pain), GHS & QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) with a recall period of previous week. Dyspnoea scale items are scored on 4-point scale (1=Not at All; 4=Very Much). Scores are linearly transformed on a scale of 0-100, with high score on the scale=worst symptoms & the data was scored according to EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of items completed, it was considered as missing. FAS=all randomized participants. Number analyzed=participants with data available for analysis. n=participants with data available for analysis at specified timepoint. 9999=no participants were analyzed at this timepoint.

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	25.38 ( 26.26 )	9999 ( 9999 )	30.59 ( 30.52 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	5.09 ( 26.63 )	9999 ( 9999 )	0.89 ( 26.83 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	-0.57 ( 22.07 )	9999 ( 9999 )	-2.73 ( 31.80 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	4.17 ( 31.57 )	9999 ( 9999 )	-3.03 ( 27.14 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	3.03 ( 25.01 )	9999 ( 9999 )	-5.28 ( 25.37 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	0.00 ( 28.87 )	9999 ( 9999 )	0.00 ( 24.22 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	0.00 ( 29.24 )	9999 ( 9999 )	-4.48 ( 26.52 )
Change at End of Treatment (n=12,10,24,77)	8.33 ( 15.08 )	4.17 ( 31.57 )	16.67 ( 28.33 )	2.60 ( 26.36 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30

End point description

EORTC QLQ-C30=30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, and pain), GHS & QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) with a recall period of previous week. Insomnia scale items are scored on 4-point scale (1=Not at All; 4=Very Much). Scores are linearly transformed on a scale of 0-100, with high score on the scale=worst symptoms & the data was scored according to EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of items completed, it was considered as missing. FAS=all randomized participants. Number analyzed=participants with data available for analysis. n=participants with data available for analysis at specified timepoint. 9999=no participants were analyzed at this timepoint.

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	23.11 ( 27.85 )	9999 ( 9999 )	28.63 ( 31.77 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	0.46 ( 26.53 )	9999 ( 9999 )	-0.44 ( 20.13 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	0.57 ( 23.77 )	9999 ( 9999 )	2.19 ( 27.13 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	15.28 ( 32.57 )	9999 ( 9999 )	2.16 ( 23.78 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	6.06 ( 24.42 )	9999 ( 9999 )	2.44 ( 25.00 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	15.69 ( 20.81 )	9999 ( 9999 )	1.37 ( 25.72 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	0.00 ( 13.07 )	9999 ( 9999 )	3.98 ( 22.11 )
Change at End of Treatment (n=12,10,24,77)	-2.78 ( 17.16 )	4.17 ( 38.46 )	-13.33 ( 35.83 )	3.90 ( 25.35 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30

End point description

EORTC QLQ-C30=30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, and pain), GHS & QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) with recall period of previous week. Appetite loss scale items are scored on 4-point scale (1=Not at All; 4=Very Much). Scores are linearly transformed on a scale of 0-100, with high score on the scale=worst symptoms & the data was scored according to EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of items completed, it was considered as missing. FAS=all randomized participants. Number analyzed=participants with data available for analysis. n=participants with data available for analysis at specified timepoint. 9999=no participants were analyzed at this timepoint.

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	16.67 ( 28.14 )	9999 ( 9999 )	21.96 ( 28.43 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	2.31 ( 32.30 )	9999 ( 9999 )	2.22 ( 23.46 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	2.87 ( 30.13 )	9999 ( 9999 )	-2.19 ( 26.44 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	4.17 ( 30.00 )	9999 ( 9999 )	-3.03 ( 27.14 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	6.06 ( 35.09 )	9999 ( 9999 )	-2.03 ( 25.31 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	-1.96 ( 18.52 )	9999 ( 9999 )	-0.46 ( 26.35 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	0.00 ( 13.07 )	9999 ( 9999 )	0.00 ( 25.29 )
Change at End of Treatment (n=11,10,24,76)	-6.06 ( 25.03 )	0.00 ( 31.08 )	3.33 ( 36.68 )	2.63 ( 25.97 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30

End point description

EORTC QLQ-C30=30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, and pain), GHS & QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) with a recall period of previous week. Constipation scale items are scored on 4-point scale (1=Not at All; 4=Very Much). Scores are linearly transformed on scale of 0-100, with high score on the scale=worst symptoms & the data was scored according to EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of items completed, it was considered as missing. FAS=all randomized participants. Number analyzed=participants with data available for analysis. n=participants with data available for analysis at specified timepoint. 9999=no participants were analyzed at this timepoint.

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	19.32 ( 30.63 )	9999 ( 9999 )	21.96 ( 33.55 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	0.00 ( 29.07 )	9999 ( 9999 )	-2.67 ( 32.77 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	-4.60 ( 28.92 )	9999 ( 9999 )	-3.28 ( 30.25 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	-4.17 ( 20.41 )	9999 ( 9999 )	-9.52 ( 34.98 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	-3.03 ( 25.01 )	9999 ( 9999 )	-6.10 ( 30.60 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	-1.96 ( 21.96 )	9999 ( 9999 )	-4.11 ( 29.37 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	-4.76 ( 17.82 )	9999 ( 9999 )	-1.00 ( 32.29 )
Change at End of Treatment (n=11,10,24,77)	-12.12 ( 45.39 )	1.39 ( 23.01 )	16.67 ( 39.28 )	-3.46 ( 35.29 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30

End point description

EORTC QLQ-C30=30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, and pain), GHS & QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) with a recall period of previous week. Diarrhoea scale items are scored on 4-point scale (1=Not at All; 4=Very Much). Scores are linearly transformed on scale of 0-100, with high score on the scale=worst symptoms & the data was scored according to EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of items completed, it was considered as missing. FAS=all randomized participants. Number analyzed=participants with data available for analysis. n=participants with data available for analysis at specified timepoint. 9999=no participants were analyzed at this timepoint.

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	88	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=88,85,0,0)	5.68 ( 15.35 )	9999 ( 9999 )	7.06 ( 15.51 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=72,75,0,0)	0.93 ( 18.53 )	9999 ( 9999 )	2.22 ( 18.45 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=58,61,0,0)	-2.30 ( 17.51 )	9999 ( 9999 )	3.28 ( 21.69 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	2.78 ( 16.79 )	9999 ( 9999 )	-1.30 ( 19.82 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	4.55 ( 18.67 )	9999 ( 9999 )	2.03 ( 19.14 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	9.80 ( 34.89 )	9999 ( 9999 )	-1.83 ( 16.56 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	9.52 ( 30.46 )	9999 ( 9999 )	0.50 ( 22.09 )
Change at End of Treatment (n=12,10,24,77)	-5.56 ( 19.25 )	5.56 ( 27.22 )	-13.33 ( 23.31 )	-0.43 ( 20.59 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30

End point description

EORTC QLQ-C30=30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, and pain), GHS & QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) with recall period of previous week. Financial difficulties scale items are scored on 4-point scale(1=Not at All; 4=Very Much). Scores are linearly transformed on scale of 0-100, with high score on the scale=worst symptoms & data was scored according to EORTC scoring manual v3.0. In the event of incomplete data, if > 50% of constituent items were completed, a pro-rated score was computed. For subscales < 50% of items completed, it was considered as missing. FAS=all randomized participants. Number analyzed=participants with data available for analysis. n=participants with data available for analysis at specified timepoint. 9999=no participants were analyzed at this timepoint.

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	87	24	85	81
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=87,85,0,0)	13.79 ( 25.19 )	9999 ( 9999 )	20.39 ( 31.33 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=71,75,0,0)	7.98 ( 27.87 )	9999 ( 9999 )	-1.33 ( 23.53 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=57,61,0,0)	11.11 ( 32.33 )	9999 ( 9999 )	0.00 ( 25.09 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,76)	9999 ( 9999 )	0.00 ( 17.03 )	9999 ( 9999 )	-0.44 ( 28.54 )
Change at Cycle 10 Day 1 (n=0,0,22,81)	9999 ( 9999 )	0.00 ( 14.55 )	9999 ( 9999 )	1.65 ( 27.34 )
Change at Cycle 13 Day 1 (n=0,0,17,71)	9999 ( 9999 )	-1.96 ( 14.29 )	9999 ( 9999 )	2.35 ( 28.35 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	-2.38 ( 8.91 )	9999 ( 9999 )	5.47 ( 26.33 )
Change at End of Treatment (n=11,10,24,76)	24.24 ( 44.95 )	-1.39 ( 20.80 )	0.00 ( 35.14 )	5.70 ( 29.51 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30

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End point title

Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30

End point description

EORTC QLQ-C30 consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom scales (fatigue, nausea and vomiting, pain), global health/ QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding Global Health Status (Q29: GHS; "How would you rate your overall health during the past week?") and QoL (Q30: QoL; "How would you rate your overall quality of life during the past week?") and were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized. Scores range from 0-100. A higher score indicates a better outcome. FAS=all randomized participants. Number analyzed=participants with data available for analysis. n=participants with data available for analysis at specified timepoint. 9999=no participants were analyzed at this timepoint.

End point type

Secondary

End point timeframe

Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

End point values	Crossover Atezolizumab IV/SC	Continuation Atezolizumab IV	Crossover Atezolizumab SC/IV	Continuation Atezolizumab SC
Number of subjects analysed	87	24	85	82
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=87,85,0,0)	67.05 ( 19.97 )	9999 ( 9999 )	64.80 ( 21.45 )	9999 ( 9999 )
Change at Cycle 3 Day 1 (n=71,75,0,0)	0.12 ( 22.95 )	9999 ( 9999 )	-0.22 ( 18.43 )	9999 ( 9999 )
Change at Cycle 6 Day 1 (n=57,61,0,0)	-2.49 ( 18.83 )	9999 ( 9999 )	-0.27 ( 22.26 )	9999 ( 9999 )
Change at Cycle 7 Day 1 (n=0,0,24,77)	9999 ( 9999 )	-2.08 ( 19.85 )	9999 ( 9999 )	1.84 ( 19.94 )
Change at Cycle 10 Day 1 (n=0,0,22,82)	9999 ( 9999 )	-3.79 ( 16.21 )	9999 ( 9999 )	1.73 ( 17.65 )
Change at Cycle 13 Day 1 (n=0,0,17,73)	9999 ( 9999 )	-5.39 ( 15.29 )	9999 ( 9999 )	0.23 ( 19.24 )
Change at Cycle 16 Day 1 (n=0,0,14,67)	9999 ( 9999 )	-7.74 ( 18.33 )	9999 ( 9999 )	3.23 ( 21.07 )
Change at End of Treatment (n=11,10,24,77)	-28.79 ( 26.71 )	-13.54 ( 25.40 )	-11.67 ( 19.72 )	-4.76 ( 22.56 )

No statistical analyses for this end point

Secondary: Percentage of Participants With Adverse Events (AEs)

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End point title

Percentage of Participants With Adverse Events (AEs)

End point description

An AE is untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to the investigational product. Percentages have been rounded off.

End point type

Secondary

End point timeframe

Up to approximately 2 years

End point values	Continuation Atezolizumab IV	Continuation Atezolizumab SC	Crossover Atezolizumab IV	Crossover Atezolizumab SC
Number of subjects analysed	26	89	160	155
Units: percentage of participants
number (not applicable)	76.9	67.4	59.4	47.7

No statistical analyses for this end point

Secondary: Percentage of Participants With Ongoing Clinical Benefit

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End point title

Percentage of Participants With Ongoing Clinical Benefit

End point description

Participants were assessed for clinical benefit at every tumour assessment visit, which was conducted as per the local standard of care. FAS included all randomized participants. Percentages have been rounded off.

End point type

Secondary

End point timeframe

Up to Cycle 16 (cycle length= 21 days)

End point values	Atezolizumab
Number of subjects analysed	179
Units: percentage of participants
number (not applicable)	44.7

No statistical analyses for this end point

Secondary: Percentage of Participants With AEs During Treatment Crossover Period

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End point title

Percentage of Participants With AEs During Treatment Crossover Period

End point description

An AE is untoward medical occurrence in participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. The safety of switching from atezolizumab SC to atezolizumab IV and from atezolizumab IV to atezolizumab SC is being assessed in this outcome measure. Safety evaluable population included all participants who received at least one dose of study treatment. In this analysis, participants were grouped by study arm and treatment period during the Crossover Period. Percentages have been rounded off.

End point type

Secondary

End point timeframe

From Cycle 1 Day 1 up to Cycle 3 Day 21; From Cycle 4 Day 1 up to Cycle 6 Day 21 (cycle length=21 days)

End point values	Atezolizumab IV/SC (Cycles 1 to 3)	Atezolizumab IV/SC (Cycles 4 to 6)	Atezolizumab SC/IV (Cycles 1 to 3)	Atezolizumab SC/IV (Cycles 4 to 6)
Number of subjects analysed	89	69	86	71
Units: percentage of participants
number (not applicable)	62.9	39.1	54.7	53.5

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to 90 days after final dose of study drug (Up to 2.4 years)

Adverse event reporting additional description

Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

27.1

Reporting group title

Crossover Atezolizumab IV

Reporting group description

Reporting group title

Crossover Atezolizumab SC

Reporting group description

Reporting group title

All Participants: All Study Treatment Periods

Reporting group description

This arm includes all participants who were administered atezolizumab IV, 1200 mg, and/or SC, 1875 mg Q3W up to Cycle 16 in the Treatment Crossover Period and Treatment Continuation Period for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.

Reporting group title

Continuation Atezolizumab SC

Reporting group description

Reporting group title

Continuation Atezolizumab IV

Reporting group description

Serious adverse events	Crossover Atezolizumab IV	Crossover Atezolizumab SC	All Participants: All Study Treatment Periods	Continuation Atezolizumab SC	Continuation Atezolizumab IV
Total subjects affected by serious adverse events
subjects affected / exposed	15 / 160 (9.38%)	13 / 155 (8.39%)	45 / 175 (25.71%)	12 / 89 (13.48%)	6 / 26 (23.08%)
number of deaths (all causes)	16	21	54	12	5
number of deaths resulting from adverse events	1	4	9	3	1
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infusion related reaction
subjects affected / exposed	2 / 160 (1.25%)	0 / 155 (0.00%)	2 / 175 (1.14%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0	2 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injection related reaction
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Peripheral ischaemia
subjects affected / exposed	1 / 160 (0.63%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Shock
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
Hypertension
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardiac tamponade
subjects affected / exposed	1 / 160 (0.63%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	1 / 160 (0.63%)	1 / 155 (0.65%)	2 / 175 (1.14%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Autoimmune myocarditis
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 2	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune-mediated myocarditis
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	1 / 160 (0.63%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	2 / 175 (1.14%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 1	0 / 0
Encephalopathy
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myasthenia gravis
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune-mediated encephalitis
subjects affected / exposed	2 / 160 (1.25%)	0 / 155 (0.00%)	2 / 175 (1.14%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dizziness
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	1 / 160 (0.63%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pain
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chest pain
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
Death
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
Non-cardiac chest pain
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Immune-mediated enterocolitis
subjects affected / exposed	1 / 160 (0.63%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	1 / 160 (0.63%)	1 / 155 (0.65%)	2 / 175 (1.14%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	2 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
subjects affected / exposed	0 / 160 (0.00%)	2 / 155 (1.29%)	2 / 175 (1.14%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 2	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	3 / 175 (1.71%)	2 / 89 (2.25%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	2 / 2	2 / 4	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	1 / 160 (0.63%)	0 / 155 (0.00%)	2 / 175 (1.14%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	2 / 175 (1.14%)	0 / 89 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Sepsis
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19
subjects affected / exposed	1 / 160 (0.63%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 160 (0.63%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	2 / 160 (1.25%)	1 / 155 (0.65%)	4 / 175 (2.29%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 4	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	3 / 175 (1.71%)	1 / 89 (1.12%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 1	1 / 3	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
Skin infection
subjects affected / exposed	1 / 160 (0.63%)	0 / 155 (0.00%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	4 / 175 (2.29%)	3 / 89 (3.37%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hyponatraemia
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	1 / 175 (0.57%)	0 / 89 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	0 / 160 (0.00%)	0 / 155 (0.00%)	1 / 175 (0.57%)	1 / 89 (1.12%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Crossover Atezolizumab IV	Crossover Atezolizumab SC	All Participants: All Study Treatment Periods	Continuation Atezolizumab SC	Continuation Atezolizumab IV
Total subjects affected by non serious adverse events
subjects affected / exposed	60 / 160 (37.50%)	52 / 155 (33.55%)	172 / 175 (98.29%)	44 / 89 (49.44%)	16 / 26 (61.54%)
Investigations
Blood creatinine increased
subjects affected / exposed	4 / 160 (2.50%)	4 / 155 (2.58%)	15 / 175 (8.57%)	6 / 89 (6.74%)	2 / 26 (7.69%)
occurrences all number	5	4	17	6	2
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 160 (0.63%)	0 / 155 (0.00%)	5 / 175 (2.86%)	2 / 89 (2.25%)	2 / 26 (7.69%)
occurrences all number	1	0	5	2	2
General disorders and administration site conditions
Injection site reaction
subjects affected / exposed	0 / 160 (0.00%)	16 / 155 (10.32%)	19 / 175 (10.86%)	3 / 89 (3.37%)	0 / 26 (0.00%)
occurrences all number	0	24	27	3	0
Asthenia
subjects affected / exposed	9 / 160 (5.63%)	8 / 155 (5.16%)	23 / 175 (13.14%)	6 / 89 (6.74%)	1 / 26 (3.85%)
occurrences all number	9	9	25	6	1
Fatigue
subjects affected / exposed	6 / 160 (3.75%)	7 / 155 (4.52%)	14 / 175 (8.00%)	1 / 89 (1.12%)	2 / 26 (7.69%)
occurrences all number	6	7	16	1	2
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	3 / 160 (1.88%)	3 / 155 (1.94%)	9 / 175 (5.14%)	1 / 89 (1.12%)	2 / 26 (7.69%)
occurrences all number	3	3	9	1	2
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	9 / 160 (5.63%)	10 / 155 (6.45%)	24 / 175 (13.71%)	7 / 89 (7.87%)	4 / 26 (15.38%)
occurrences all number	11	10	36	10	5
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	7 / 160 (4.38%)	7 / 155 (4.52%)	21 / 175 (12.00%)	7 / 89 (7.87%)	2 / 26 (7.69%)
occurrences all number	7	7	23	7	2
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	10 / 160 (6.25%)	4 / 155 (2.58%)	18 / 175 (10.29%)	5 / 89 (5.62%)	1 / 26 (3.85%)
occurrences all number	10	5	22	6	1
Pruritus
subjects affected / exposed	9 / 160 (5.63%)	8 / 155 (5.16%)	21 / 175 (12.00%)	8 / 89 (8.99%)	0 / 26 (0.00%)
occurrences all number	9	8	30	13	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	6 / 160 (3.75%)	1 / 155 (0.65%)	13 / 175 (7.43%)	3 / 89 (3.37%)	3 / 26 (11.54%)
occurrences all number	6	1	13	3	3
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	5 / 160 (3.13%)	6 / 155 (3.87%)	16 / 175 (9.14%)	3 / 89 (3.37%)	2 / 26 (7.69%)
occurrences all number	5	6	16	3	2
Arthralgia
subjects affected / exposed	6 / 160 (3.75%)	3 / 155 (1.94%)	15 / 175 (8.57%)	7 / 89 (7.87%)	0 / 26 (0.00%)
occurrences all number	8	3	18	7	0
Pain in extremity
subjects affected / exposed	2 / 160 (1.25%)	2 / 155 (1.29%)	9 / 175 (5.14%)	5 / 89 (5.62%)	1 / 26 (3.85%)
occurrences all number	3	2	11	5	1
Infections and infestations
Conjunctivitis
subjects affected / exposed	0 / 160 (0.00%)	1 / 155 (0.65%)	3 / 175 (1.71%)	0 / 89 (0.00%)	2 / 26 (7.69%)
occurrences all number	0	1	3	0	2
Bronchitis
subjects affected / exposed	3 / 160 (1.88%)	0 / 155 (0.00%)	9 / 175 (5.14%)	6 / 89 (6.74%)	0 / 26 (0.00%)
occurrences all number	3	0	9	6	0
Upper respiratory tract infection
subjects affected / exposed	3 / 160 (1.88%)	0 / 155 (0.00%)	7 / 175 (4.00%)	3 / 89 (3.37%)	2 / 26 (7.69%)
occurrences all number	3	0	9	4	2
COVID-19
subjects affected / exposed	3 / 160 (1.88%)	2 / 155 (1.29%)	11 / 175 (6.29%)	4 / 89 (4.49%)	2 / 26 (7.69%)
occurrences all number	3	2	11	4	2
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	3 / 160 (1.88%)	5 / 155 (3.23%)	10 / 175 (5.71%)	1 / 89 (1.12%)	2 / 26 (7.69%)
occurrences all number	3	5	11	1	2

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Were there any global substantial amendments to the protocol? Yes

28 Feb 2022

1. An error was corrected in the rational for the participant population regarding the dose to be used. 2. The eligibility requirement for a life expectancy of ≥18 weeks was updated to be in the opinion of the investigator. 3. A pathology report must also be provided if samples were sent to a central laboratory for EGFR and/or Anaplastic Lymphoma Kinase (ALK) testing. 4. Coagulation testing was only required at screening.

07 Mar 2023

1. The two exploratory immunogenicity objectives were merged into one streamlined objective encompassing the two. 2. The estimated sample size of the study was increased from approximately 140 participants to approximately 175 participants. 3. Endobronchial ultrasound-guided transbronchial needle aspiration was clarified to be an accepted sampling method for a right thoracotomy. 4. The definitions of the study populations and variables were replaced by cross-references to the Statistical Analysis Plan. 5. Steps 7 and 8 of the procedure in the event of a suspected anaphylactic reaction during study treatment infusion were removed because they are no longer required for atezolizumab. 6. The list of identified risks for atezolizumab was revised to include facial paresis, myelitis, pericardial disorders, and hemophagocytic lymphohistiocytosis. 7. The autoimmune diseases and immune deficiencies table in Appendix 7 was revised to include autoimmune myelitis.

27 Feb 2024

1. The list of approved indications for atezolizumab has been updated to include alveolar soft part sarcoma. 2. The safety follow-up duration was clarified to include safety follow-up every 90 days until the end of the trial 3. Personal identifiable information (i.e., name and telephone number) for the Medical Monitors has been removed from the protocol (front matter and Section 5.4.1). Medical Monitor contact information in Section 5.4.1 has been replaced with a sentence indicating that this information will be provided separately to sites.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Randomized, Multicenter, Open-Label Cross-Over Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non–Small Cell Lung Cancer

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ)

Primary: Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ)

Secondary: Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire – Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)

Secondary: Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire – Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)

Secondary: Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period

Secondary: Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period

Secondary: Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of HCPQs – Drug Preparation Area

Secondary: Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of HCPQs – Drug Preparation Area

Secondary: Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ – Drug Preparation Area

Secondary: Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ – Drug Preparation Area

Secondary: Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area

Secondary: Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area

Secondary: Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs – Treatment Room

Secondary: Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs – Treatment Room

Secondary: Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ – Treatment Room

Secondary: Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ – Treatment Room

Secondary: Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room

Secondary: Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room

Secondary: Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room

Secondary: Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room

Secondary: Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC-QLQ-C30)

Secondary: Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC-QLQ-C30)

Secondary: Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30

Secondary: Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30

Secondary: Percentage of Participants With Adverse Events (AEs)

Secondary: Percentage of Participants With Adverse Events (AEs)

Secondary: Percentage of Participants With Ongoing Clinical Benefit

Secondary: Percentage of Participants With Ongoing Clinical Benefit

Secondary: Percentage of Participants With AEs During Treatment Crossover Period

Secondary: Percentage of Participants With AEs During Treatment Crossover Period

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized, Multicenter, Open-Label Cross-Over Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non–Small Cell Lung Cancer