drugset / Trial / NCT02576574
Avelumab in First-line NSCLC (JAVELIN Lung 100)
Phase 3
Completed
1214 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2015-10-29
- Primary completion
- 2021-12-06
- Completion
- 2024-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |