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)

Last updated: February 10, 2026
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

REGN7075

Platinum-based chemotherapy

Cemiplimab

Clinical Study ID

NCT06465329
R2810-ONC-2268
2023-509806-31-00
  • Ages > 18
  • All Genders

Study 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

Inclusion

General Key Inclusion Criteria:

  1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is consideredresectable 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 forsubmission, 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

Exclusion

General Key Exclusion Criteria:

  1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as describedin 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, asdescribed in the protocol

  3. Presence of grade≥ 2 peripheral neuropathy

  4. Another malignancy that is progressing or requires active treatment, as described inthe 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 immuneeffector cell-associated neurotoxicity syndrome (ICANS), as described in theprotocol

  3. Has marked baseline prolongation of the time from the start of the Q wave to the endof the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or riskfactors for prolonged QTc, as described in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: REGN7075
Phase: 2
Study Start date:
November 18, 2024
Estimated Completion Date:
May 02, 2030

Connect with a study center

  • Oncology Clinical Research Center

    Cachoeiro de Itapemirim 3468376, Espírito Santo 3463930 29306014
    Brazil

    Active - Recruiting

  • Instituto Mario Penna

    Belo Horizonte 3470127, Minas Gerais 3457153 30380-472
    Brazil

    Active - Recruiting

  • Instituto Sul Mineiro De Oncologia LTDA

    Pouso Alegre 3452525, Minas Gerais 3457153 37554-238
    Brazil

    Active - Recruiting

  • Instituto de Medicina Integral Professor Fernando Figueira

    Recife 3390760, Pernambuco 3392268 50070-902
    Brazil

    Active - Recruiting

  • Liga Norte Riograndense Contra o Cancer

    Natal 3394023, Rio Grande do Norte 3390290 59060-195
    Brazil

    Active - Recruiting

  • Hospital Mae de Deus Integrated Oncology Center

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90110-270
    Brazil

    Active - Recruiting

  • Hospital Sao Lucas da PUCRS

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90610-000
    Brazil

    Active - Recruiting

  • Ynova Pesquisa Clinica

    Florianópolis 3463237, Santa Catarina 3450387 88020-210
    Brazil

    Active - Recruiting

  • Unimed Sorocaba

    Sorocaba 3447399, São Paulo 3448433 18065-100
    Brazil

    Active - Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São José do Rio Preto 3448639, São Paulo 3448433 15090-000
    Brazil

    Active - Recruiting

  • Hospital Alemao Oswaldo Cruz

    São Paulo 3448439, 01323-903
    Brazil

    Active - Recruiting

  • CHU Rennes

    Rennes 2983990, Brittany Region 3030293 35033
    France

    Active - Recruiting

  • Institut Curie

    Paris, Ile De France 75005
    France

    Site Not Available

  • Centre Hospitalier Intercommunal Toulon - CHITS

    Toulon, Var 83055
    France

    Site Not Available

  • Centre Hospitalier Intercommunal Toulon - CHITS

    Toulon 2972328, Var 83055
    France

    Active - Recruiting

  • Institut Curie

    Paris 2988507, Île-de-France Region 3012874 75005
    France

    Active - Recruiting

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100
    France

    Active - Recruiting

  • Clinique Belharra

    Bayonne, 64100
    France

    Site Not Available

  • Centre Hospitalier de la Cote Basque

    Bayonne 3034475, 64100
    France

    Active - Recruiting

  • Clinique Belharra

    Bayonne 3034475, 64100
    France

    Active - Recruiting

  • CHU Grenoble Alpes

    Grenoble, 38330
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble 3014728, 38330
    France

    Active - Recruiting

  • Montpellier Academic Hospital

    Montpellier, 34295
    France

    Site Not Available

  • Montpellier Academic Hospital

    Montpellier 2992166, 34295
    France

    Active - Recruiting

  • CHU Rennes

    Rennes, 35033
    France

    Site Not Available

  • Klinikum Kassel GmbH, Hauttumorzentrum

    Kassel 2892518, Hesse 2905330 34125
    Germany

    Active - Recruiting

  • Klinikum Kassel GmbH, Hauttumorzentrum

    Kassel, Hessen 34125
    Germany

    Site Not Available

  • University Medicine Gottingen

    Gottingen, Lower Saxony 37083
    Germany

    Site Not Available

  • University Medicine Gottingen

    Göttingen 2918632, Lower Saxony 2862926 37083
    Germany

    Active - Recruiting

  • University of Leipzig

    Leipzig 2879139, Saxony 2842566 04103
    Germany

    Active - Recruiting

  • University Hospital RWTH Aachen

    Aachen 3247449, 52074
    Germany

    Active - Recruiting

  • Catalan Instituye of Oncology Badalona

    Badalona 3129028, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Universitario Marques

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Valdecilla

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Active - Recruiting

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, Las Palmas 35016
    Spain

    Site Not Available

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria 2515270, Las Palmas 35016
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Clinico San Carlos

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid 3117735, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid 3117735, 28046
    Spain

    Active - Recruiting

  • MD Anderson Cancer Center

    Madrid 3117735, 28033
    Spain

    Active - Recruiting

  • Hospital Virgen del Rocio

    Seville, 41013
    Spain

    Site Not Available

  • Hospital Virgen del Rocio

    Seville 2510911, 41013
    Spain

    Active - Recruiting

  • Consorci Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Consorci Hospital General Universitario de Valencia

    Valencia 2509954, 46014
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Valencia

    Valencia 2509954, 46010
    Spain

    Active - Recruiting

  • Hospital Clinico Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Clinico Lozano Blesa

    Zaragoza 3104324, 50009
    Spain

    Active - Recruiting

  • Florya Medical Park Hospital

    Istanbul, 34295
    Turkey

    Site Not Available

  • Florya Medical Park Hospital

    Istanbul 745044, 34295
    Turkey (Türkiye)

    Active - Recruiting

  • University of California Irvine

    Orange, California 92868
    United States

    Site Not Available

  • University of California Irvine

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • Orchard Healthcare Research Inc.

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Orchard Healthcare Research Inc.

    Skokie 4911600, Illinois 4896861 60077
    United States

    Active - Recruiting

  • Prairie Lakes Healthcare System

    Watertown, Massachusetts 57201
    United States

    Site Not Available

  • Prairie Lakes Healthcare System

    Watertown 4954611, Massachusetts 6254926 57201
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Detroit Clinical Research Center

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Active - Recruiting

  • Detroit Clinical Research Center

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Active - Recruiting

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland 5746545, Oregon 5744337 97213
    United States

    Active - Recruiting

  • University Of Nebraska Medical Center

    Portland 5746545, Oregon 5744337 97213
    United States

    Active - Recruiting

  • Lifespan Cancer Institute

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Lifespan Cancer Institute

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Active - Recruiting

  • Prairie Lakes Healthcare System

    Watertown 5232741, South Dakota 5769223 57201
    United States

    Active - Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Tennessee Medical Center

    Knoxville 4634946, Tennessee 4662168 37920
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • BRCC/Oncology & Hematology Associates of SW Virginia

    Blacksburg 4747845, Virginia 6254928 24060
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.