Trial · NCT03125902
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status | From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Months | MEDIAN |
| PRIMARY | Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population | From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) | ITT population: all randomized participants, whether or not the assigned study treatment was received | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in the PD-L1-Positive Subpopulation | From Day 1 to death from any cause, assessed up 36 months | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in the ITT Population | From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months) | ITT population: all randomized participants, whether or not the assigned study treatment was received | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Are Alive at 12 and 18 Months | From Day 1 to death from any cause, assessed up to 12 and 18 months | ITT population: all randomized participants, whether or not the assigned study treatment was received | Percentage of Participants | NUMBER |
| SECONDARY | Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population | From Day 1 to deterioration, assessed up 64 months | PRO-evaluable populations: participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the questionnaire of interest (European Organization for the Research and Treatment of Cancer \[EORTC\] Quality-of-life Questionnaire \[QLQ\] C30, EORTC QLQ BR-23 or FACT-G) | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1 | From Day 1 to PD or death from any cause, assessed up to 12 months | ITT population: all randomized participants, whether or not the assigned study treatment was received | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed ) | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed) | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed ) | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) | Response-evaluable population: participants in the ITT population with measurable disease at baseline | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed ) | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) | Response-evaluable population: participants in the ITT population with measurable disease at baseline | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed) | From objective response to PD, assessed up to primary completion date (approximately 26 months) | Duration of response (DoR)-evaluable population: participants in the ITT population with measurable disease at baseline | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) | Clinical Benefit Rate analysis included all participants with unconfirmed PR/CR or SD of at least 6 months duration | Percentage of Participants | NUMBER |
| SECONDARY | Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population | Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months). | PK-evaluable population: all participants who received any dose of Atezolizumab and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | μg/mL | MEAN |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population | C1D1 30 min postdose | PK-evaluable population: all participants who received any dose of Atezolizumab and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | μg/mL | MEAN |
| SECONDARY | Minimum Observed Plasma Concentration (Cmin) of Paclitaxel | Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days) | PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Paclitaxel | Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days) | PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | From Day 1 From baseline up to 64 months | Safety-evaluable population: participants who received any amount of any study drug. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population | Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days) | Anti-Drug Antibody (ADA) population:~* Baseline ADA-evaluable population: all participants with at least one evaluable ADA assay result from a baseline sample~* Post baseline ADA-Evaluable population: all participants with at least one evaluable ADA assay result from at least one post-baseline sample.~For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | Percentage of Participants | NUMBER |
| SECONDARY | Overall Survival by PD-L1 Status, Intent to Treat Population | From Day 1 up to 66 months | ITT population: all randomized participants, whether or not the assigned study treatment was received | Months | MEDIAN |
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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