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Trial · NCT04738487

Outcomes50

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYOverall Survival (OS) in Participants With PD-L1 TPS ≥50%Up to ~39 monthsThe analysis population consisted of all participants with PD-L1 TPS ≥ 50% who were randomized prior to the primary completion data cut-off.MonthsMEDIAN
SECONDARYOS in Participants With PD-L1 TPS ≥1%Up to ~39 monthsThe analysis population consisted of all participants with PD-L1 TPS ≥ 1% who were randomized prior to the primary completion data cut-off.MonthsMEDIAN
SECONDARYOS in Participants With PD-L1 TPS 1% to 49%Up to ~39 monthsThe analysis population consisted of all participants with PD-L1 TPS 1% to 49% who were randomized prior to the primary completion data cut-off.MonthsMEDIAN
SECONDARYProgression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%Up to ~56 months
SECONDARYPFS in Participants With PD-L1 TPS ≥50%Up to ~56 months
SECONDARYPFS in Participants With PD-L1 TPS 1% to 49%Up to ~56 months
SECONDARYObjective Response Rate (ORR) in Participants With PD-L1 TPS ≥1%Up to ~56 months
SECONDARYORR in Participants With PD-L1 TPS ≥50%Up to ~56 months
SECONDARYORR in Participants With PD-L1 TPS 1% to 49%Up to ~56 months
SECONDARYDuration of Response (DOR) in Participants With PD-L1 TPS ≥50%Up to ~56 months
SECONDARYDOR in Participants With PD-L1 TPS 1% to 49%Up to ~56 months
SECONDARYDOR in Participants With PD-L1 TPS ≥1%Up to ~56 months
SECONDARY
Change From Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) in Participants With PD-L1 TPS ≥50%
Baseline and up to ~56 months
SECONDARYChange From Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%Baseline and up to ~56 months
SECONDARYChange From Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%Baseline and up to ~56 months
SECONDARYChange From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%Baseline and up to ~56 months
SECONDARYChange From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%Baseline and up to ~56 months
SECONDARYChange From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%Baseline and up to ~56 months
SECONDARYChange From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%Baseline and up to ~56 months
SECONDARYChange From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%Baseline and up to ~56 months

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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