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NCT03409614 · ClinicalTrials.gov registry record · Phase 3
Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 789
- Enrollment target
NCT03409614: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT03409614 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 789 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03409614, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 789 participants
- Enrollment target
Study Summary
The primary objectives of this study are: Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression. The key secondary objectives are: Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
Primary Outcome
OS was defined as the time from randomization to the date of death due to any cause.
Interventions
- DRUG Placebo
- DRUG REGN2810
- OTHER Chemotherapy
- DRUG REGN2810/chemo/ipi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 789 participants |
| Start Date | 2018-03-06 |
| Est. Completion | 2025-02-27 |
| Phase | Phase 3 |
What the finished NCT03409614 record still lists
NCT03409614 is an interventional study that assigns participants to a tested intervention. The registered 789 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03409614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03409614 about?
NCT03409614 is a clinical study titled "Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer". The primary objectives of this study are: Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tu...
What is the current status of trial NCT03409614?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 789 participants. The study started on 2018-03-06. Estimated completion is 2025-02-27.
What interventions are being tested in trial NCT03409614?
The interventions under investigation include: Placebo (DRUG), REGN2810 (DRUG), Chemotherapy (OTHER), REGN2810/chemo/ipi (DRUG).
Who is sponsoring clinical trial NCT03409614?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03409614's enrollment target sits among peer trials
789 431st of 2000 higher than 1,570 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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