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NCT06465329PHASE2Recruiting

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)

Regeneron Pharmaceuticals

Start Date

11/18/2024

Completion Date

5/2/2030

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 Criteria

Age Range: 18 years to No maximum

General Key Inclusion Criteria: 1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol 2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol 4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1 5. Adequate organ and bone marrow function, as described in the protocol General Key Exclusion Criteria: 1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol 2. Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol 3. Presence of grade≥ 2 peripheral neuropathy 4. Another malignancy that is progressing or requires active treatment, as described in the protocol Arm Specific Exclusion Criteria: Arm 1: 1. Grade ≥3 hypercalcemia, as defined in the protocol 2. Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol 3. Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol Note: Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

Cemiplimab

DRUG

Platinum-based chemotherapy

DRUG

REGN7075

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Conditions

Non-Small Cell Lung Cancer

Locations

University of California Irvine

Orange, California 92868

United States

Orchard Healthcare Research Inc.

Skokie, Illinois 60077

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Detroit Clinical Research Center

Farmington Hills, Michigan 48334

United States

Morristown Medical Center

Morristown, New Jersey 07960

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Oncology Hematology Care Clinical Trials LLC

Cincinnati, Ohio 45245

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

University Of Nebraska Medical Center

Portland, Oregon 97213

United States

Lifespan Cancer Institute

Providence, Rhode Island 02903

United States

Prairie Lakes Healthcare System

Watertown, South Dakota 57201

United States

University of Tennessee Medical Center

Knoxville, Tennessee 37920

United States

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee 37203

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

BRCC/Oncology & Hematology Associates of SW Virginia

Blacksburg, Virginia 24060

United States

Oncology Clinical Research Center

Cachoeiro de Itapemirim, Espírito Santo 29306014

Brazil

Instituto Mario Penna

Belo Horizonte, Minas Gerais 30380-472

Brazil

Instituto Sul Mineiro De Oncologia LTDA

Pouso Alegre, Minas Gerais 37554-238

Brazil

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco 50070-902

Brazil

Liga Norte Riograndense Contra o Cancer

Natal, Rio Grande do Norte 59060-195

Brazil

Hospital Mae de Deus Integrated Oncology Center

Porto Alegre, Rio Grande do Sul 90110-270

Brazil

Hospital Sao Lucas da PUCRS

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Ynova Pesquisa Clinica

Florianópolis, Santa Catarina 88020-210

Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo 15090-000

Brazil

Unimed Sorocaba

Sorocaba, São Paulo 18065-100

Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, 01323-903

Brazil

CHU Rennes

Rennes, Brittany Region 35033

France

Centre Hospitalier Intercommunal Toulon - CHITS

Toulon, Var 83055

France

Centre Hospitalier de la Cote Basque

Bayonne, 64100

France

Clinique Belharra

Bayonne, 64100

France

CHU Grenoble Alpes

Grenoble, 38330

France

Montpellier Academic Hospital

Montpellier, 34295

France

Institut Curie

Paris, Île-de-France Region 75005

France

Klinikum Kassel GmbH, Hauttumorzentrum

Kassel, Hesse 34125

Germany

University Medicine Gottingen

Göttingen, Lower Saxony 37083

Germany

University of Leipzig

Leipzig, Saxony 04103

Germany

University Hospital RWTH Aachen

Aachen, 52074

Germany

Catalan Instituye of Oncology Badalona

Badalona, Barcelona 08916

Spain

Hospital Valdecilla

Santander, Cantabria 39008

Spain

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas 35016

Spain

Clinica Universidad de Navarra

Pamplona, Navarre 31008

Spain

MD Anderson Cancer Center

Madrid, 28033

Spain

Hospital Universitario Clinico San Carlos

Madrid, 28040

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario HM Sanchinarro

Madrid, 28050

Spain

Hospital Virgen del Rocio

Seville, 41013

Spain

Hospital Clinico Universitario Valencia

Valencia, 46010

Spain

Consorci Hospital General Universitario de Valencia

Valencia, 46014

Spain

Hospital Clinico Lozano Blesa

Zaragoza, 50009

Spain

Florya Medical Park Hospital

Istanbul, 34295

Turkey (Türkiye)