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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 is a Phase 3 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03515629
The ClinicalTrials.gov registry entry for NCT03515629 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03515629 reports 0 study locations.
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.
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