RecruitingPhase 2NCT06465329

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


Sponsor

Regeneron Pharmaceuticals

Enrollment

120 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

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)?


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding extra treatments to the standard combination of immunotherapy (cemiplimab) and chemotherapy improves outcomes for people with operable non-small cell lung cancer (NSCLC) before and after surgery. **You may be eligible if...** - You have been diagnosed with stage II to IIIB (N2) non-small cell lung cancer that surgeons believe can be fully removed - You are in good overall health (ECOG 0-1) - Adequate organ and bone marrow function **You may NOT be eligible if...** - Your cancer is not potentially curable with surgery - You have had prior systemic cancer treatments - You have autoimmune conditions that could be worsened by immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCemiplimab

Intravenous (IV) infusion administration

DRUGPlatinum-based chemotherapy

IV infusion

DRUGREGN7075

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)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06465329