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NCT03515629 · ClinicalTrials.gov registry record · Phase 3
REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
NCT03515629: Clinical Trial Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT03515629 is a Phase 3 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 5 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03515629, a Phase 3 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
Study Summary
The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as "REGN2810/chemo/ipi") with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.
Primary Outcome
Per protocol, the final analysis of PFS was to be performed after observing 142 PFS events in the pembrolizumab treatment arm. PFS was not assessed due to insufficient data collected.
Interventions
- DRUG Pembrolizumab
- DRUG REGN2810/chemo/ipi
- DRUG REGN2810/ipi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-07-02 |
| Est. Completion | 2021-07-29 |
| Phase | Phase 3 |
Why NCT03515629 stopped before completion
NCT03515629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03515629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03515629 about?
NCT03515629 is a clinical study titled "REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer". The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (here...
What is the current status of trial NCT03515629?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2018-07-02. Estimated completion is 2021-07-29.
What interventions are being tested in trial NCT03515629?
The interventions under investigation include: Pembrolizumab (DRUG), REGN2810/chemo/ipi (DRUG), REGN2810/ipi (DRUG).
Who is sponsoring clinical trial NCT03515629?
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 NCT03515629's enrollment target sits among peer trials
5 1997th of 2000 higher than 3 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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