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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
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Clermont Oncology Center
Clermont, Florida, United States
University of Illinois
Chicago, Illinois, United States
University of Kansas Cancer Center-Westwood
Westwood, Kansas, United States
Henry Ford Health System
Detroit, Michigan, United States
Mercy South
St Louis, Missouri, United States
University of Rochester
Rochester, New York, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Virginia Cancer Care Specialist, PC
Fairfax, Virginia, United States
Eastern Health
Box Hill, Victoria, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
Start Date
July 16, 2024
Primary Completion Date
April 17, 2026
Completion Date
November 4, 2029
Last Updated
January 12, 2026
195
ACTUAL participants
Fianlimab
DRUG
Cemiplimab
DRUG
Pemetrexed
DRUG
Paclitaxel
DRUG
Carboplatin
DRUG
Cisplatin
DRUG
Placebo
DRUG
Lead Sponsor
Regeneron Pharmaceuticals
NCT06169956
NCT05247684
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04056247