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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 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 789 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03409614
The ClinicalTrials.gov registry entry for NCT03409614 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 789 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 4 interventions - of which Placebo is the first listed.
NCT03409614 reports 0 study locations.
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.
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