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
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EudraCT number |
2021-004067-28 |
Trial protocol |
IT ES FI LV |
Global end of trial date |
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Nov 2024
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First version publication date |
06 Nov 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MO43576
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05171777 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
F. Hoffmann-La Roche AG
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4058
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Public contact |
F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
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Scientific contact |
F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Interim
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Date of interim/final analysis |
09 Nov 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Nov 2023
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Global end of trial reached? |
No
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General information about the trial
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Main objective of the trial |
The study aims to evaluate participant preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).
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Protection of trial subjects |
All study subjects were required to read and sign an Informed Consent Form.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Apr 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Argentina: 21
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Country: Number of subjects enrolled |
Brazil: 4
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Country: Number of subjects enrolled |
Canada: 8
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Country: Number of subjects enrolled |
Costa Rica: 8
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Country: Number of subjects enrolled |
Chile: 1
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Country: Number of subjects enrolled |
Finland: 8
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Country: Number of subjects enrolled |
Italy: 20
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Country: Number of subjects enrolled |
Korea, Democratic People's Republic of: 14
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Country: Number of subjects enrolled |
Latvia: 20
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Country: Number of subjects enrolled |
Poland: 28
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Country: Number of subjects enrolled |
Spain: 39
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Country: Number of subjects enrolled |
United States: 8
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Worldwide total number of subjects |
179
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EEA total number of subjects |
115
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
74
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From 65 to 84 years |
102
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85 years and over |
3
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Recruitment
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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). This study is still ongoing. | ||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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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
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Period 1 title |
Treatment Crossover Period
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
RO5541267
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Other name |
Tecentriq, MPDL3280A
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Subcutaneous use
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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.
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Investigational medicinal product name |
Atezolizumab IV
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Investigational medicinal product code |
RO5541267
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Other name |
Tecentriq, MPDL3280A
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intravenous use
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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.
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Arm title
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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
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Investigational medicinal product code |
RO5541267
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Other name |
Tecentriq, MPDL3280A
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intravenous use
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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.
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Investigational medicinal product name |
Atezolizumab SC
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Investigational medicinal product code |
RO5541267
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Other name |
Tecentriq, MPDL3280A
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Subcutaneous use
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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.
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Period 2
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Period 2 title |
Treatment Continuation Period
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
RO5541267
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Other name |
Tecentriq, MPDL3280A
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intravenous use
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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.
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Arm title
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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
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Investigational medicinal product code |
RO5541267
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Other name |
Tecentriq, MPDL3280A
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Subcutaneous use
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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.
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Baseline characteristics reporting groups
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Reporting group title |
Crossover Atezolizumab IV/SC
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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
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Crossover Atezolizumab IV/SC
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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
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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
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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
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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)
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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.
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Subject analysis set title |
Atezolizumab IV/SC (Cycles 4 to 6)
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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.
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Subject analysis set title |
Atezolizumab SC/IV (Cycles 1 to 3)
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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.
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Subject analysis set title |
Atezolizumab SC/IV (Cycles 4 to 6)
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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.
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Subject analysis set title |
Atezolizumab IV/SC
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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.
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Subject analysis set title |
Atezolizumab SC/IV
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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.
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Subject analysis set title |
Crossover + Continuation Periods (Atezolizumab IV/SC)
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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.
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Subject analysis set title |
Crossover + Continuation Periods (Atezolizumab SC/IV)
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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.
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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.
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End point type |
Primary
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End point timeframe |
Cycle 6 Day 1 (cycle length=21 days)
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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. |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Cycles 3 Day 1 and Cycle 6 Day 1 (cycle length=21 days)
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Cycle 6 Day 1 (Cycle length=21 days)
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Day 1 of Cycles 1 to 6 (cycle length= 21 days)
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Cycle 6 Day 1 (cycle length=21 days)
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Cycle 6 Day 1 (cycle length= 21 days)
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
|
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End point timeframe |
Day 1 of Cycles 1 to 6 (cycle length=21 days)
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
|
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End point timeframe |
Cycle 6 Day 1 (cycle length=21 days)
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
|
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End point timeframe |
Cycle 6 Day 1 (cycle length=21 days)
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
|
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End point timeframe |
Cycle 6 Day 1 (cycle length= 21 days)
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No statistical analyses for this end point |
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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.
|
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End point type |
Secondary
|
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End point timeframe |
From Day 1 up to 30 days after last study dose (up to approximately 2 years)
|
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|
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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. |
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No statistical analyses for this end point |
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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.
|
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End point type |
Secondary
|
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End point timeframe |
From Day 1 up to 30 days after last study dose (up to approximately 2 years)
|
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|
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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. |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
|
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End point timeframe |
From Day 1 up to 30 days after last study dose (up to approximately 2 years)
|
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|
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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. |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
|
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End point timeframe |
After Cycle 16 (cycle length=21 days)
|
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|
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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. |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
|
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End point timeframe |
Up to approximately 2 years
|
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|
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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. |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
|
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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)
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No statistical analyses for this end point |
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Adverse events information
|
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Timeframe for reporting adverse events |
Cycle 1 Day 1 up to Cycle 6 Day 21 (cycle length=21 days)
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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.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.1
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Reporting groups
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Reporting group title |
Crossover Atezolizumab SC
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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
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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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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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. |
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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. |
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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. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |