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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

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2024
    First version publication date
    06 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MO43576
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05171777
    WHO universal trial number (UTN)
    		 -
    Sponsors
    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
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    09 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2023
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The study aims to evaluate participant preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).
    Protection of trial subjects
    All study subjects 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
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 21
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Costa Rica: 8
    Country: Number of subjects enrolled
    Chile: 1
    Country: Number of subjects enrolled
    Finland: 8
    Country: Number of subjects enrolled
    Italy: 20
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 14
    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
    United States: 8
    Worldwide total number of subjects
    179
    EEA total number of subjects
    115
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    74
    From 65 to 84 years
    102
    85 years and over
    3

    Subject disposition

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    Recruitment
    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). This study is still ongoing.

    Pre-assignment
    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
    Period 1 title
    Treatment Crossover Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 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 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 as SC on Day 1 of each 21-day cycle for 3 cycles or until loss of clinical benefit.

    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 for 3 cycles or until loss of clinical benefit.

    Arm title
    		 Crossover Atezolizumab SC/IV
    Arm 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.
    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 for 3 cycles 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 as SC on Day 1 of each 21-day cycle for 3 cycles or until loss of clinical benefit.

    Number of subjects in period 1
    		Crossover Atezolizumab IV/SC Crossover Atezolizumab SC/IV
    Started
    89
    90
    Completed
    53
    54
    Not completed
    36
    36
         Consent withdrawn by subject
    4
    4
         Disease Relapse
    -
    1
         Physician decision
    -
    1
         Adverse Event
    9
    6
         Death
    5
    5
         Progressive Disease
    13
    9
         Ongoing in the Crossover Treatment Period
    3
    6
         Symptomatic Deterioration
    -
    1
         Reason not Specified
    2
    1
         Protocol deviation
    -
    2
    Period 2
    Period 2 title
    Treatment Continuation Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 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.

    Arm title
    		 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 as 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
    22
    85
    Completed
    0
    0
    Not completed
    22
    85
         Death
    1
    6
         Ongoing in Continuation Treatment Period
    21
    79

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Crossover Atezolizumab IV/SC
    Reporting group 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.

    Reporting group title
    Crossover Atezolizumab SC/IV
    Reporting group 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.

    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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    End points reporting groups
    Reporting group title
    Crossover Atezolizumab IV/SC
    Reporting group 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.

    Reporting group title
    Crossover Atezolizumab SC/IV
    Reporting group 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.
    Reporting group title
    Continuation Atezolizumab IV
    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 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.

    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
    Crossover + Continuation Periods (Atezolizumab IV/SC)
    Subject analysis set type
    		 Full 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. After 6 cycles, participants could choose between IV or SC administration of atezolizumab in the Treatment Continuation Period. Participants continue to receive atezolizumab IV, 1200 mg or 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
    Crossover + Continuation Periods (Atezolizumab SC/IV)
    Subject analysis set type
    		 Full 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. After 6 cycles, participants could choose between IV or SC administration of atezolizumab in the Treatment Continuation Period. Participants continue to receive atezolizumab IV, 1200 mg or 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.

    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 the Question 1 (Q1) of PPQ. Q1 (All things considered, which route of administration did you prefer?) asks participants to report their preference for the route of administration (IV, SC, or no preference). A point estimate with associated 95% CI for the percentage of participants who preferred atezolizumab SC was calculated. Participants experiencing any of the following events: treatment withdrawal prior to eligibility for PPQ, or death without answering Q1 of PPQ, or treatment not started; were excluded from the analysis set. Participants who answered Q1 of the PPQ without having at least 2 consecutive administrations of treatment with each administration modality (SC and IV) were excluded from the analysis. Full Analysis Set (FAS) included all randomized participants. Number analyzed is the number of participants who answered Q1 of PPQ. Percentages have been 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: No formal statistical analysis was planned for this endpoint.
    End point values
    		 Crossover Atezolizumab IV/SC Crossover Atezolizumab SC/IV
    Number of subjects analysed
    60
    63
    Units: percentage of participants
        number (confidence interval 95%)
    71.67 (58.56 to 82.55)
    69.84 (56.98 to 80.77)
    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: 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 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.
    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
    53
    54
    Units: percentage of participants
        number (not applicable)
    79.2
    79.6
    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 (n=57,60)
    7.0
    10.0
        a=Disagree (n=57,60)
    7.0
    0
        a=Neutral (n=57,60)
    21.1
    31.7
        a=Agree (n=57,60)
    24.6
    20.0
        a=Strongly Agree (n=57,60)
    31.6
    25.0
        a=Not Applicable (n=57,60)
    3.5
    1.7
        a=Missing (n=57,60)
    5.3
    11.7
        b=Strongly Disagree (n=57,60)
    7.0
    10.0
        b=Disagree (n=57,60)
    14.0
    8.3
        b=Neutral (n=57,60)
    29.8
    28.3
        b=Agree (n=57,60)
    12.3
    18.3
        b=Strongly Agree (n=57,60)
    24.6
    16.7
        b=Not Applicable (n=57,60)
    7.0
    6.7
        b=Missing (n=57,60)
    5.3
    11.7
        c=Strongly Disagree (n=57,60)
    0
    0
        c=Disagree (n=57,60)
    8.8
    0
        c=Neutral (n=57,60)
    29.8
    53.3
        c=Agree (n=57,60)
    26.3
    18.3
        c=Strongly Agree (n=57,60)
    26.3
    15.0
        c=Not Applicable (n=57,60)
    3.5
    1.7
        c=Missing (n=57,60)
    5.3
    11.7
        d=Strongly Disagree (n=57,60)
    12.3
    20.0
        d=Disagree (n=57,60)
    12.3
    3.3
        d=Neutral (n=57,60)
    22.8
    30.0
        d=Agree (n=57,60)
    15.8
    18.3
        d=Strongly Agree (n=57,60)
    28.1
    15.0
        d=Not Applicable (n=57,60)
    3.5
    1.7
        d=Missing (n=57,60)
    5.3
    11.7
        e=Strongly Disagree (n=57,60)
    1.8
    0
        e=Disagree (n=57,60)
    19.3
    11.7
        e=Neutral (n=57,60)
    14.0
    26.7
        e=Agree (n=57,60)
    29.8
    38.3
        e=Strongly Agree (n=57,60)
    26.3
    10.0
        e=Not Applicable (n=57,60)
    3.5
    1.7
        e=Missing (n=57,60)
    5.3
    11.7
        f=Strongly Disagree (n=57,60)
    0
    1.7
        f=Disagree (n=57,60)
    10.5
    5.0
        f=Neutral (n=57,60)
    33.3
    46.7
        f=Agree (n=57,60)
    21.1
    20.0
        f=Strongly Agree (n=57,60)
    26.3
    8.3
        f=Not Applicable (n=57,60)
    3.5
    6.7
        f=Missing (n=57,60)
    5.3
    11.7
        g=Strongly Disagree (n=57,60)
    5.3
    11.7
        g=Disagree (n=57,60)
    5.3
    1.7
        g=Neutral (n=57,60)
    26.3
    36.7
        g=Agree (n=57,60)
    26.3
    21.7
        g=Strongly Agree (n=57,60)
    28.1
    15.0
        g=Not Applicable (n=57,60)
    3.5
    1.7
        g=Missing (n=57,60)
    5.3
    11.7
        h=Strongly Disagree (n=57,60)
    0
    0
        h=Disagree (n=57,60)
    0
    0
        h=Neutral (n=57,60)
    10.5
    15.0
        h=Agree (n=57,60)
    40.4
    38.3
        h=Strongly Agree (n=57,60)
    28.1
    25.0
        h=Not Applicable (n=57,60)
    15.8
    10.0
        h=Missing (n=57,60)
    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 (n=57,60)
    71.9
    58.3
        Q3=Atezolizumab IV (n=57,60)
    0
    0
        Q3=No Difference (n=57,60)
    17.5
    21.7
        Q3= Missing (n=57,60)
    10.5
    20.0
        Q4=Atezolizumab SC (n=57,60)
    64.9
    60.0
        Q4=Atezolizumab IV (n=57,60)
    3.5
    0
        Q4=No Difference (n=57,60)
    21.1
    20.0
        Q4=Missing (n=57,60)
    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 (n=61,89)
    13.8
    11.5
        a=Disagree (n=61,89)
    15.5
    23.0
        a=Neutral (n=61,89)
    1.7
    6.6
        a=Agree (n=61,89)
    27.6
    23.0
        a=Strongly Agree (n=61,89)
    17.2
    14.8
        a=Not Applicable (n=61,89)
    10.3
    1.6
        a=Missing (n=61,89)
    13.8
    19.7
        b=Strongly Disagree (n=61,89)
    5.3
    1.6
        b=Disagree (n=61,89)
    19.0
    14.8
        b=Neutral (n=61,89)
    10.3
    21.3
        b=Agree (n=61,89)
    22.4
    21.3
        b=Strongly Agree (n=61,89)
    27.6
    21.3
        b=Not Applicable (n=61,89)
    1.7
    0
        b=Missing (n=61,89)
    13.8
    19.7
        c=Strongly Disagree (n=61,89)
    5.2
    0
        c=Disagree (n=61,89)
    15.5
    16.4
        c=Neutral (n=61,89)
    12.1
    23.0
        c=Agree (n=61,89)
    25.9
    26.2
        c=Strongly Agree (n=61,89)
    27.6
    14.8
        c=Not Applicable (n=61,89)
    0
    0
        c=Missing (n=61,89)
    13.8
    19.7
        d=Strongly Disagree (n=61,89)
    6.9
    1.6
        d=Disagree (n=61,89)
    5.2
    6.6
        d=Neutral (n=61,89)
    25.9
    31.1
        d=Agree (n=61,89)
    19.0
    23.0
        d=Strongly Agree (n=61,89)
    27.6
    18.0
        d=Not Applicable (n=61,89)
    1.7
    0
        d=Missing (n=61,89)
    13.8
    19.7
        e=Strongly Disagree (n=61,89)
    13.8
    11.5
        e=Disagree (n=61,89)
    8.6
    14.8
        e=Neutral (n=61,89)
    27.6
    26.2
        e=Agree (n=61,89)
    10.3
    11.5
        e=Strongly Agree (n=61,89)
    19.0
    13.1
        e=Not Applicable (n=61,89)
    6.9
    3.3
        e=Missing (n=61,89)
    13.8
    19.7
        f=Strongly Disagree (n=61,89)
    0
    0
        f=Disagree (n=61,89)
    17.2
    11.5
        f=Neutral (n=61,89)
    17.2
    32.8
        f=Agree (n=61,89)
    22.4
    16.4
        f=Strongly Agree (n=61,89)
    29.3
    19.7
        f=Not Applicable (n=61,89)
    0
    0
        f=Missing (n=61,89)
    13.8
    19.7
        g=Strongly Disagree (n=61,89)
    6.9
    1.6
        g=Disagree (n=61,89)
    12.1
    11.5
        g=Neutral (n=61,89)
    27.6
    27.9
        g=Agree (n=61,89)
    13.8
    24.6
        g=Strongly Agree (n=61,89)
    25.9
    14.8
        g=Not Applicable (n=61,89)
    0
    0
        g=Missing (n=61,89)
    13.8
    19.7
        h=Strongly Disagree (n=61,89)
    6.9
    0
        h=Disagree (n=61,89)
    17.2
    24.6
        h=Neutral (n=61,89)
    15.5
    13.1
        h=Agree (n=61,89)
    24.1
    29.5
        h=Strongly Agree (n=61,89)
    20.7
    13.1
        h=Not Applicable (n=61,89)
    1.7
    0
        h=Missing (n=61,89)
    13.8
    19.7
        i=Strongly Disagree (n=61,89)
    1.7
    1.6
        i=Disagree (n=61,89)
    5.2
    4.9
        i=Neutral (n=61,89)
    8.6
    14.8
        i=Agree (n=61,89)
    37.9
    27.9
        i=Strongly Agree (n=61,89)
    32.8
    31.1
        i=Not Applicable (n=61,89)
    0
    0
        i=Missing (n=61,89)
    13.8
    19.7
        j=Strongly Disagree (n=61,89)
    1.7
    1.6
        j=Disagree (n=61,89)
    0
    3.3
        j=Neutral (n=61,89)
    20.7
    21.3
        j=Agree(n=61,89)
    31.0
    27.9
        j=Strongly Agree (n=61,89)
    31.0
    26.2
        j=Not Applicable (n=61,89)
    1.7
    0
        j=Missing (n=61,89)
    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 (n=58,61)
    72.4
    63.9
        Q3=Atezolizumab IV (n=58,61)
    5.2
    10.1
        Q3=No Difference (n=58,61)
    6.9
    8.4
        Q3=Unsure (n=58,61)
    1.7
    3.3
        Q3= Missing (n=58,61)
    13.8
    14.4
        Q4=Atezolizumab SC (n=58,61)
    55.2
    39.3
        Q4=Atezolizumab IV (n=58,61)
    6.9
    1.5
        Q4=No Difference (n=58,61)
    20.7
    31.1
        Q4=Unsure (n=58,61)
    3.4
    1.6
        Q4=Missing (n=58,61)
    13.8
    16.4
        Q5=Atezolizumab SC (n=58,61)
    67.2
    52.5
        Q5=Atezolizumab IV (n=58,61)
    0
    3.3
        Q5=No Difference (n=58,61)
    17.2
    27.9
        Q5=Unsure (n=58,61)
    0
    0
        Q5=Missing (n=58,61)
    15.5
    16.4
        Q6=Atezolizumab SC (n=58,61)
    63.8
    50.8
        Q6=Atezolizumab IV (n=58,61)
    3.4
    1.6
        Q6=No Difference (n=58,61)
    19.0
    31.1
        Q6=Unsure (n=58,61)
    0
    0
        Q6=Missing (n=58,61)
    13.8
    16.4
        Q7=Atezolizumab SC (n=58,61)
    63.8
    52.5
        Q7=Atezolizumab IV (n=58,61)
    10.3
    14.8
        Q7=No Difference (n=58,61)
    3.4
    1.6
        Q7=Unsure (n=58,61)
    8.6
    14.8
        Q7=Missing (n=58,61)
    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 (n=58,61)
    41.4
    31.1
        Q8=Sometimes (n=58,61)
    34.5
    37.7
        Q8=Never (n=58,61)
    10.3
    14.8
        Q8=Missing (n=58,61)
    13.8
    16.4
    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. Data collection is ongoing for this endpoint and results will be disclosed within 1 year from Study Completion Date.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 30 days after last study dose (up to approximately 2 years)
    End point values
    		 Crossover + Continuation Periods (Atezolizumab IV/SC) Crossover + Continuation Periods (Atezolizumab SC/IV)
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [2] - Data collection is ongoing, and results will be disclosed within 1 year from Study Completion Date.
    [3] - Data collection is ongoing, and results will be disclosed within 1 year from Study Completion Date.
    No statistical analyses for this end point

    Secondary: Change From Baseline Over Time in Symptoms as Assessed by EORTC-QLQ-C30

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    End point title
    		 Change From Baseline Over Time in Symptoms as Assessed by EORTC-QLQ-C30
    End point description
    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptoms items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. Data collection is ongoing for this endpoint and results will be disclosed within 1 year from Study Completion Date.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 30 days after last study dose (up to approximately 2 years)
    End point values
    		 Crossover + Continuation Periods (Atezolizumab IV/SC) Crossover + Continuation Periods (Atezolizumab SC/IV)
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [4] - Data collection is ongoing, and results will be disclosed within 1 year from Study Completion Date.
    [5] - Data collection is ongoing, and results will be disclosed within 1 year from Study Completion Date.
    No statistical analyses for this end point

    Secondary: Change From Baseline Over Time in Participant Functioning 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 Participant Functioning 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 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. Data collection is ongoing for this endpoint and results will be disclosed within 1 year from Study Completion Date.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 30 days after last study dose (up to approximately 2 years)
    End point values
    		 Crossover + Continuation Periods (Atezolizumab IV/SC) Crossover + Continuation Periods (Atezolizumab SC/IV)
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [6] - Data collection is ongoing, and results will be disclosed within 1 year from Study Completion Date.
    [7] - Data collection is ongoing, and results will be disclosed within 1 year from Study Completion Date.
    No statistical analyses for this end point

    Secondary: Number of Participants With Ongoing Clinical Benefit

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    End point title
    		 Number of Participants With Ongoing Clinical Benefit
    End point description
    Data collection is ongoing for this endpoint and results will be disclosed within 1 year from Study Completion Date.
    End point type
    Secondary
    End point timeframe
    After Cycle 16 (cycle length=21 days)
    End point values
    		 Crossover + Continuation Periods (Atezolizumab IV/SC) Crossover + Continuation Periods (Atezolizumab SC/IV)
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: participants
    Notes
    [8] - Data collection is ongoing, and results will be disclosed within 1 year from Study Completion Date.
    [9] - Data collection is ongoing, and results will be disclosed within 1 year from Study Completion Date.
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events (AEs)

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    End point title
    		 Number of Participants With Adverse Events (AEs)
    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. Data collection is ongoing for this endpoint and results will be disclosed within 1 year from Study Completion Date.
    End point type
    Secondary
    End point timeframe
    Up to approximately 2 years
    End point values
    		 Crossover + Continuation Periods (Atezolizumab IV/SC) Crossover + Continuation Periods (Atezolizumab SC/IV)
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: participants
    Notes
    [10] - Data collection is ongoing, and results will be disclosed within 1 year from Study Completion Date.
    [11] - Data collection is ongoing, and results will be disclosed within 1 year from Study Completion Date.
    No statistical analyses for this end point

    Secondary: Number of Participants With AEs During Treatment Crossover Period

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    End point title
    		 Number 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.
    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: participants
    56
    27
    47
    38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Cycle 1 Day 1 up to Cycle 6 Day 21 (cycle length=21 days)
    Adverse event reporting additional description
    Safety evaluable population included all participants who received at least one dose of study treatment. This study is still ongoing. Safety data up to end of Treatment Crossover Period (i.e., end of Cycle 6) is presented here.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Crossover Atezolizumab SC
    Reporting group 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.

    Reporting group title
    Crossover Atezolizumab IV
    Reporting group 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.

    Serious adverse events
    		 Crossover Atezolizumab SC Crossover Atezolizumab IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 155 (8.39%)
    15 / 160 (9.38%)
         number of deaths (all causes)
    17
    19
         number of deaths resulting from adverse events
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 155 (0.00%)
    2 / 160 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    0 / 155 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 155 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    0 / 155 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated myocarditis
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune myocarditis
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 155 (0.65%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated encephalitis
         subjects affected / exposed
    0 / 155 (0.00%)
    2 / 160 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 155 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 155 (0.65%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated enterocolitis
         subjects affected / exposed
    0 / 155 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 155 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 155 (1.29%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Skin infection
         subjects affected / exposed
    0 / 155 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 155 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 155 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 155 (0.65%)
    2 / 160 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Crossover Atezolizumab SC Crossover Atezolizumab IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 155 (25.81%)
    42 / 160 (26.25%)
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    15 / 155 (9.68%)
    0 / 160 (0.00%)
         occurrences all number
    23
    0
    Fatigue
         subjects affected / exposed
    7 / 155 (4.52%)
    6 / 160 (3.75%)
         occurrences all number
    7
    6
    Asthenia
         subjects affected / exposed
    8 / 155 (5.16%)
    9 / 160 (5.63%)
         occurrences all number
    9
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 155 (6.45%)
    9 / 160 (5.63%)
         occurrences all number
    10
    11
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 155 (2.58%)
    9 / 160 (5.63%)
         occurrences all number
    5
    9
    Pruritus
         subjects affected / exposed
    8 / 155 (5.16%)
    9 / 160 (5.63%)
         occurrences all number
    8
    9

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    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.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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