NCT05785767

A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab (also called REGN2810), individually called a "study drug" or collectively called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab and cemiplimab is in treating advanced NSCLC, in comparison with cemiplimab by itself. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much study drug is in your blood at different times * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects) * How administering the study drugs might improve your quality of life

Conditions

• Advanced Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	fianlimab	Every three weeks (Q3W) as intravenous (IV) co-infusion
DRUG	cemiplimab	Q3W as IV co-infusion
DRUG	Placebo	Q3W as IV co-infusion

Timeline

• Start date: 2023-06-30
• Primary completion: 2030-03-11
• Completion: 2032-02-05
• First posted: 2023-03-27
• Last updated: 2026-01-22

Locations

106 sites across 11 countries: United States, Australia, Canada, Georgia, Israel, Malaysia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study