Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 14 of 14

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Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population	After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020	ITT population (full population) is defined as all randomized participants.	Number of Participants	NUMBER
PRIMARY	Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System	After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020	PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.	Number of Participants	NUMBER
SECONDARY	Event-Free Survival (EFS) in All Participants	From randomization and up to study final analysis data cut off on 28 September 2022.	ITT population (full population) is defined as all randomized participants.	Months	MEDIAN
SECONDARY	Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status	From randomization and up to study final analysis data cut off on 28 September 2022.	PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.	Months	NUMBER
SECONDARY	Disease-Free Survival (DFS) in All Participants Who Undergo Surgery	From surgery and up to study final analysis data cut off on 28 September 2022.	ITT population (full population) is defined as all randomized participants. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS.	Months	MEDIAN
SECONDARY	Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery	From surgery and up to study final analysis data cut off on 28 September 2022.	PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS in the Subpopulation of Participants with PD-L1-Positive Tumor Status.	Months	MEDIAN
SECONDARY	Overall Survival (OS) in All Participants	From randomization and up to study final analysis data cut off on 28 September 2022.	ITT population (full population) is defined as all randomized participants.	Months	MEDIAN
SECONDARY	Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status	From randomization and up to study final analysis data cut off on 28 September 2022.	PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.	Months	MEDIAN
SECONDARY	Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30	From randomization and up to study final analysis data cut off on 28 September 2022.	All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment.	Score on a 0-100 scale	MEAN
SECONDARY	Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30	From randomization and up to study final analysis data cut off on 28 September 2022.	All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment.	Score on a 0-100 scale.	MEAN
SECONDARY	Percentage of Participants With at Least One Adverse Events (AEs)	From randomization and up to study final analysis data cut off on 28 September 2022.	Safety population is defined as all participants who received any dose of study medication.	Percentage of participants	NUMBER
SECONDARY	Minimum Observed Serum Atezolizumab Concentration (Cmin)	Pre-dose on Day 1 of Cycles 2, 3, 4, 6, 8, 12, and 16 (cycle length = 28 days from Cycles 1 to 5, and 21 days from Cycles 6 to 16)	The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.	µg/mL	MEAN
SECONDARY	Maximum Observed Serum Atezolizumab Concentration (Cmax)	Day 1 of Cycle 1 post dose (cycle length = 28 days)	The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.	µg/mL	MEAN
SECONDARY	Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab	Baseline up to approximately 20 months	The anti-drug antibodies (ADA)-evaluable population is defined as all participants treated with atezolizumab who have at least one post-baseline ADA result.	Percentage of participants	NUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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