Clinical Trial: NCT03409614
Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Regeneron Pharmaceuticals |
| Information Provided By: | Regeneron Pharmaceuticals |
| Last Update Posted: | 2026-05-18 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: REGN2810
- Drug: REGN2810/chemo/ipi
- Other: Chemotherapy
- Drug: Placebo
Other Study ID Numbers
- R2810-ONC-16113
- 2017-001311-36
- 2017
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Regeneron Pharmaceuticals |
| Information Provided By: | Regeneron Pharmaceuticals |
| Last Update Posted: | 2026-05-18 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: REGN2810
- Drug: REGN2810/chemo/ipi
- Other: Chemotherapy
- Drug: Placebo
Other Study ID Numbers
- R2810-ONC-16113
- 2017-001311-36
- 2017