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
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol

• Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1

• Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol

• Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1

• Adequate organ and bone marrow function, as described in the protocol

Locations
United States
California
University of California Irvine
RECRUITING
Orange
Illinois
Orchard Healthcare Research Inc.
RECRUITING
Skokie
Massachusetts
Prairie Lakes Healthcare System
RECRUITING
Watertown
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Detroit Clinical Research Center
RECRUITING
Farmington Hills
New Jersey
Morristown Medical Center
RECRUITING
Morristown
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Oregon
Providence Portland Medical Center
RECRUITING
Portland
Rhode Island
Lifespan Cancer Institute
RECRUITING
Providence
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Tennessee Oncology
RECRUITING
Nashville
Other Locations
Brazil
Oncology Clinical Research Center
RECRUITING
Cachoeiro De Itapemirim
Liga Norte Riograndense Contra o Cancer
RECRUITING
Natal
Instituto de Medicina Integral Professor Fernando Figueira
RECRUITING
Recife
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
RECRUITING
São José Do Rio Preto
France
Centre Hospitalier de la Cote Basque
RECRUITING
Bayonne
Clinique Belharra
RECRUITING
Bayonne
CHU Grenoble Alpes
RECRUITING
Grenoble
Montpellier Academic Hospital
RECRUITING
Montpellier
Institut Curie
RECRUITING
Paris
CHU Rennes
RECRUITING
Rennes
Centre Hospitalier Intercommunal Toulon - CHITS
RECRUITING
Toulon
Germany
University Hospital RWTH Aachen
RECRUITING
Aachen
University Medicine Gottingen
RECRUITING
Göttingen
Klinikum Kassel GmbH, Hauttumorzentrum
RECRUITING
Kassel
University of Leipzig
RECRUITING
Leipzig
Spain
Hospital Universitario Insular de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Hospital Valdecilla
RECRUITING
Santander
Hospital Virgen del Rocio
RECRUITING
Seville
Consorci Hospital General Universitario de Valencia
RECRUITING
Valencia
Hospital Clinico Universitario Valencia
RECRUITING
Valencia
Hospital Clinico Lozano Blesa
RECRUITING
Zaragoza
Turkey
Florya Medical Park Hospital
RECRUITING
Istanbul
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2030-05-02
Participants
Target number of participants: 120
Treatments
Active_comparator: Chemotherapy+Cemiplimab
Control treatment
Experimental: Arm 1: Chemotherapy+Cemiplimab+REGN7075
Investigational Treatment
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

Similar Clinical Trials