NCT03409614

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 790 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	REGN2810	REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
DRUG	REGN2810/chemo/ipi	REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
OTHER	Chemotherapy	Platinum-based doublet chemotherapy Part 1
DRUG	Placebo	Matching placebo Part 2

Timeline

• Start date: 2018-03-06
• Primary completion: 2025-02-27
• Completion: 2025-02-27
• First posted: 2018-01-24
• Last updated: 2025-03-13

Locations

133 sites across 18 countries: United States, Austria, China, France, Georgia, Greece, Ireland, Italy, Lithuania, Malaysia, Poland, Romania, Russia, Slovakia, South Korea, Thailand, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study