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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)
Sponsor: Regeneron Pharmaceuticals
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)?
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-11-18
Completion Date
2030-05-02
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Cemiplimab
Intravenous (IV) infusion administration
Platinum-based chemotherapy
IV infusion
REGN7075
IV infusion
Locations (49)
University of California Irvine
Orange, California, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, United States
Morristown Medical Center
Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Providence Portland Medical Center
Portland, Oregon, United States
University Of Nebraska Medical Center
Portland, Oregon, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
Prairie Lakes Healthcare System
Watertown, South Dakota, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
BRCC/Oncology & Hematology Associates of SW Virginia
Blacksburg, Virginia, United States
Oncology Clinical Research Center
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Instituto Mario Penna
Belo Horizonte, Minas Gerais, Brazil
Instituto Sul Mineiro De Oncologia LTDA
Pouso Alegre, Minas Gerais, Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, Brazil
Liga Norte Riograndense Contra o Cancer
Natal, Rio Grande do Norte, Brazil
Hospital Mae de Deus Integrated Oncology Center
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Ynova Pesquisa Clinica
Florianópolis, Santa Catarina, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Unimed Sorocaba
Sorocaba, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
CHU Rennes
Rennes, Brittany Region, France
Centre Hospitalier Intercommunal Toulon - CHITS
Toulon, Var, France
Centre Hospitalier de la Cote Basque
Bayonne, France
Clinique Belharra
Bayonne, France
CHU Grenoble Alpes
Grenoble, France
Montpellier Academic Hospital
Montpellier, France
Institut Curie
Paris, Île-de-France Region, France
Klinikum Kassel GmbH, Hauttumorzentrum
Kassel, Hesse, Germany
University Medicine Gottingen
Göttingen, Lower Saxony, Germany
University of Leipzig
Leipzig, Saxony, Germany
University Hospital RWTH Aachen
Aachen, Germany
Catalan Instituye of Oncology Badalona
Badalona, Barcelona, Spain
Hospital Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Universitario Clinico San Carlos
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Virgen del Rocio
Seville, Spain
Hospital Clinico Universitario Valencia
Valencia, Spain
Consorci Hospital General Universitario de Valencia
Valencia, Spain
Hospital Clinico Lozano Blesa
Zaragoza, Spain
Florya Medical Park Hospital
Istanbul, Turkey (Türkiye)