NCT05800015

A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 950 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". 'Investigational' means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, in comparison with cemiplimab and chemotherapy. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much of each 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

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	fianlimab	Administered intravenously (IV) every 3 weeks (Q3W)
DRUG	cemiplimab	Administered IV Q3W
DRUG	Pemetrexed	IV Infusion, Q3W
DRUG	Paclitaxel	IV Infusion, Q3W
DRUG	Carboplatin	IV Infusion, Q3W
DRUG	Cisplatin	IV infusion, Q3W
DRUG	Placebo	IV infusion, Q3W

Timeline

• Start date: 2023-08-08
• Primary completion: 2030-01-16
• Completion: 2031-12-23
• First posted: 2023-04-05
• Last updated: 2026-01-22

Locations

76 sites across 10 countries: United States, Australia, Canada, Georgia, Israel, Malaysia, South Korea, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study