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Phase 3Completed

Avelumab in First-line NSCLC (JAVELIN Lung 100)

A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC

Sponsor
EMD Serono Research & Development Institute, Inc. (Industry)
Enrollment
1,214 enrolled
Conditions
First Line Non-Small Cell Lung Cancer
Interventions
Avelumab; Pemetrexed; Paclitaxel; Gemcitabine; Gemcitabine; Carboplatin; Cisplatin; Carboplatin; Avelumab Weekly
Ages
adults, older adults
Registry
NCT02576574, EUCTR2015-001537-24

Full record on ClinicalTrials.gov

From the registry

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

Primary outcomes

  • Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)
  • Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS)
  • Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)
  • Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

History

  1. Last registry update

  2. Study completion

  3. Results first posted

  4. Primary completion

  5. Started

  6. Registered