NCT06161441

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• 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) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery. The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC. 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 the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * How administering the study drugs might affect quality of life

Conditions

• Resectable 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	Administered IV Q3W
DRUG	Paclitaxel	Administered IV Q3W
DRUG	Carboplatin	Administered IV Q3W
DRUG	Cisplatin	Administered IV Q3W
DRUG	Placebo	Administered IV Q3W

Timeline

• Start date: 2024-07-16
• Primary completion: 2026-04-17
• Completion: 2029-11-04
• First posted: 2023-12-07
• Last updated: 2026-01-12

Locations

123 sites across 12 countries: United States, Australia, Chile, France, Georgia, Germany, Italy, Malaysia, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study