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: April 22, 2025
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 drugs (which could make the drugs 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 21, 2030

Connect with a study center

  • Institut Curie

    Paris, Ile De France 75005
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal Toulon - CHITS

    Toulon, Var 83055
    France

    Active - Recruiting

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100
    France

    Active - Recruiting

  • CHU Grenoble Alpes

    Grenoble, 38330
    France

    Active - Recruiting

  • Montpellier Academic Hospital

    Montpellier, 34295
    France

    Active - Recruiting

  • Hospital Universitario Marques

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Valdecilla

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Virgen del Rocio

    Seville, 41013
    Spain

    Active - Recruiting

  • Consorci Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Active - Recruiting

  • Hospital Clinico Lozano Blesa

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • Orchard Healthcare Research Inc.

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Detroit Clinical Research Center

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Lifespan Cancer Institute

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

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