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)

NCT06465329 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: R2810-ONC-22682023-509806-31-00
• Study Type: interventional
• Target: 120
• Locations: 6 countries
• Sites: 49

Brief 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)?

Conditions

Non-Small Cell Lung Cancer

Keywords

Lung Carcinoma; Resectable NSCLC

Outcome Measures

Primary Outcomes (1)

• Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)

  Up to 12 weeks

Secondary Outcomes (21)

• Pathologic complete response (pCR) rate as determined by central BIPR

  Up to 12 weeks

• Residual viable tumor (RVT) as determined by central BIPR

  Up to 12 weeks

• Median event-free survival (EFS)

  Up to 5 years

• EFS rate

  Up to 5 years

• Objective response rate (ORR)

  Up to 9 weeks

Study Arms (2)

Chemotherapy+Cemiplimab

ACTIVE COMPARATOR

Control treatment

Drug: Cemiplimab; Drug: Platinum-based chemotherapy

Arm 1: Chemotherapy+Cemiplimab+REGN7075

EXPERIMENTAL

Investigational Treatment

Drug: Cemiplimab; Drug: Platinum-based chemotherapy; Drug: REGN7075

Interventions

Cemiplimab DRUG

Intravenous (IV) infusion administration

Also known as: REGN2810, LIBTAYO

Arm 1: Chemotherapy+Cemiplimab+REGN7075; Chemotherapy+Cemiplimab

Platinum-based chemotherapy DRUG

IV infusion

Arm 1: Chemotherapy+Cemiplimab+REGN7075; Chemotherapy+Cemiplimab

REGN7075 DRUG

IV infusion

Also known as: EGFRxCD28 bispecific immunotherapy

Arm 1: Chemotherapy+Cemiplimab+REGN7075

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
• 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
• Presence of grade≥ 2 peripheral neuropathy
• Another malignancy that is progressing or requires active treatment, as described in the protocol
• Arm 1:
• Grade ≥3 hypercalcemia, as defined in the protocol
• Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (49)

University of California Irvine

Orange, California, 92868, United States

RECRUITING

Orchard Healthcare Research Inc.

Skokie, Illinois, 60077, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Detroit Clinical Research Center

Farmington Hills, Michigan, 48334, United States

RECRUITING

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

University Of Nebraska Medical Center

Portland, Oregon, 97213, United States

RECRUITING

Lifespan Cancer Institute

Providence, Rhode Island, 02903, United States

RECRUITING

Prairie Lakes Healthcare System

Watertown, South Dakota, 57201, United States

RECRUITING

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

BRCC/Oncology & Hematology Associates of SW Virginia

Blacksburg, Virginia, 24060, United States

RECRUITING

Oncology Clinical Research Center

Cachoeiro de Itapemirim, Espírito Santo, 29306014, Brazil

RECRUITING

Instituto Mario Penna

Belo Horizonte, Minas Gerais, 30380-472, Brazil

RECRUITING

Instituto Sul Mineiro De Oncologia LTDA

Pouso Alegre, Minas Gerais, 37554-238, Brazil

RECRUITING

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, 50070-902, Brazil

RECRUITING

Liga Norte Riograndense Contra o Cancer

Natal, Rio Grande do Norte, 59060-195, Brazil

RECRUITING

Hospital Mae de Deus Integrated Oncology Center

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

RECRUITING

Hospital Sao Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

Ynova Pesquisa Clinica

Florianópolis, Santa Catarina, 88020-210, Brazil

RECRUITING

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

Unimed Sorocaba

Sorocaba, São Paulo, 18065-100, Brazil

RECRUITING

Hospital Alemao Oswaldo Cruz

São Paulo, 01323-903, Brazil

RECRUITING

CHU Rennes

Rennes, Brittany Region, 35033, France

RECRUITING

Centre Hospitalier Intercommunal Toulon - CHITS

Toulon, Var, 83055, France

RECRUITING

Centre Hospitalier de la Cote Basque

Bayonne, 64100, France

RECRUITING

Clinique Belharra

Bayonne, 64100, France

RECRUITING

CHU Grenoble Alpes

Grenoble, 38330, France

RECRUITING

Montpellier Academic Hospital

Montpellier, 34295, France

RECRUITING

Institut Curie

Paris, Île-de-France Region, 75005, France

RECRUITING

Klinikum Kassel GmbH, Hauttumorzentrum

Kassel, Hesse, 34125, Germany

RECRUITING

University Medicine Gottingen

Göttingen, Lower Saxony, 37083, Germany

RECRUITING

University of Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

University Hospital RWTH Aachen

Aachen, 52074, Germany

RECRUITING

Catalan Instituye of Oncology Badalona

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

MD Anderson Cancer Center

Madrid, 28033, Spain

RECRUITING

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

RECRUITING

Hospital Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Hospital Clinico Universitario Valencia

Valencia, 46010, Spain

RECRUITING

Consorci Hospital General Universitario de Valencia

Valencia, 46014, Spain

RECRUITING

Hospital Clinico Lozano Blesa

Zaragoza, 50009, Spain

RECRUITING

Florya Medical Park Hospital

Istanbul, 34295, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

cemiplimab; Platinum Compounds

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 2, 2030
• Last Updated: February 12, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

DE (4); BR (11); FR (7); ES (12); TU (1); US (14)