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Trial · NCT03520946

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOverall survivalUp to 4 yearsOverall survival according to Kaplan-Meier
SecondaryOverall response rate (ORR)Up to 4 yearsORR defined as the proportion of patients with complete or partial remission according to RECIST 1.1
SecondaryDisease control rate (DCR)Up to 4 yearsDCR defined as the proportion of patients with complete or partial remission and stable disease according to RECIST 1.1
SecondaryProgression-free survival (PFS)Up to 4 yearsPFS, defined as the time from enrollment/randomization to the first occurrence of progression, as determined by the investigator using CT criteria, or death from any cause
SecondaryOverall survival (OS) rate at different time points6 months and 1 yearOS rate at 6 and 12 months, defined as patients who are alive after at 6 and 12 months, respectively
SecondaryEfficacy (ORR) subgroupUp to 4 yearsEfficacy (ORR) in patients who develop neutropenia grade ≥2 (ANC ≤1500/μl) in cycle 1
SecondaryEfficacy (PFS) subgroupUp to 4 yearsEfficacy (PFS) in patients who develop neutropenia grade ≥2 (ANC ≤1500/μl) in cycle 1
SecondaryEfficacy (OS) subgroupUp to 4 yearsEfficacy (OS) in patients who develop neutropenia grade ≥2 (ANC ≤1500/μl) in cycle 1
SecondaryQuality of life I (QoL)Up to 1 yearQuality of life (QoL) as measured by EORTC-QLQ-C30 at d1 of each cycle and on EOT (end of treatment).
SecondaryQuality of life II (QoL)Up to 1 yearQuality of life (QoL) as measured by EQ-5D-5L at d1 of each cycle and on EOT.
OtherExplorative: Overall response rate (ORR)Up to 4 yearsORR according to gene expression, mutational profiles, plasma biomarkers and radiologic analysis
OtherExplorative: Overall survival (OS)Up to 4 yearsOS according to gene expression, mutational profiles, plasma biomarkers and radiologic analysis
OtherExplorative: Progression-free survival (PFS)Up to 4 yearsPFS according to gene expression, mutational profiles, plasma biomarkers and radiologic analysis

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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