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NCT02576574 · ClinicalTrials.gov registry record · Phase 3
Avelumab in First-line NSCLC (JAVELIN Lung 100)
A Phase 3 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,214
- Enrollment target
NCT02576574: Completed Phase 3 study, sponsored by EMD Serono Research & Development Institute.
NCT02576574 is a Phase 3 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 1,214 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02576574, a Phase 3 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,214 participants
- Enrollment target
Study 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.
Primary Outcome
PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.
Interventions
- DRUG Pemetrexed
- DRUG Paclitaxel
- DRUG Gemcitabine
- DRUG Avelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,214 participants |
| Start Date | 2015-10-29 |
| Est. Completion | 2024-01-29 |
| Phase | Phase 3 |
What the finished NCT02576574 record still lists
NCT02576574 is an interventional study that assigns participants to a tested intervention. Its 1,214 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% higher).
The record links to 0 conditions, and to 4 interventions - of which Pemetrexed is the first listed.
NCT02576574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02576574 about?
NCT02576574 is a clinical study titled "Avelumab in First-line NSCLC (JAVELIN Lung 100)". 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 li...
What is the current status of trial NCT02576574?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,214 participants. The study started on 2015-10-29. Estimated completion is 2024-01-29.
What interventions are being tested in trial NCT02576574?
The interventions under investigation include: Pemetrexed (DRUG), Paclitaxel (DRUG), Gemcitabine (DRUG), Avelumab (DRUG).
Who is sponsoring clinical trial NCT02576574?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02576574's enrollment target sits among peer trials
1,214 216th of 2000 higher than 1,785 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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