NCT06465329

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned. The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug. The study is also looking at several other research questions, including: * What are the side effects associated with the investigational treatments in comparison to the control treatment? * Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed? * How much of the study drug(s) are in the blood at a given time? * Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)?

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cemiplimab	Intravenous (IV) infusion administration
DRUG	Platinum-based chemotherapy	IV infusion
DRUG	REGN7075	IV infusion

Timeline

• Start date: 2024-11-18
• Primary completion: 2027-05-20
• Completion: 2030-05-02
• First posted: 2024-06-18
• Last updated: 2026-02-12

Locations

49 sites across 6 countries: United States, Brazil, France, Germany, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study