Trial · NCT02425891
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants | Baseline up to approximately 34 months | PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first. |
| Primary | PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1) | Baseline up to approximately 34 months | PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first. |
| Primary | Overall Survival (OS) in All Randomized Participants | Baseline until death due to any cause (up to approximately 58 months) | OS was defined as the time from the date of randomization to the date of death from any cause. |
| Primary | OS in Participants With Detectable PD-L1 | Baseline until death due to any cause (up to approximately 58 months) | OS was defined as the time from the date of randomization to the date of death from any cause. |
| Secondary | Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants | Baseline up to approximately 34 months | An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1. |
| Secondary | Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1 | Baseline up to approximately 34 months | An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1. |
| Secondary | Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants | Baseline up to approximately 34 months | DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first. |
| Secondary | DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1 | Baseline up to approximately 34 months | DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first. |
| Secondary | Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants | Baseline up to approximately 58 months | Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment. |
| Secondary | TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1 | Baseline up to approximately 58 months | Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment. |
| Secondary | Percentage of Participants With at Least One Adverse Event | Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months) | Percentage of participants with at least one adverse event. |
| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab | Baseline up to approximately 53 months | Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab |
| Secondary | Maximum Serum Concentration (Cmax) for Atezolizumab | Cycle 1 Day 1 (Cycle = 28 days) | Maximum serum concentration for atezolizumab. |
| Secondary | Minimum Serum Concentration (Cmin) for Atezolizumab | Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days) | Minimum serum concentration for atezolizumab. |
| Secondary | Plasma Concentrations of Total Paclitaxel | Pre-dose (Hour 0) on Cycle 1 Day 1, pre-dose (Hour 0), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after end of nab-paclitaxel infusion (infusion duration = 30 minutes) on Cycle 3 Day 1 (Cycle = 28 days) | Plasma Concentrations of Total Paclitaxel |
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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