A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

Last updated: March 12, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Pemetrexed

Cisplatin

Placebo

Clinical Study ID

NCT06161441
R3767-ONC-2266
2023-505172-29-00
  • Ages > 18
  • All Genders

Study Summary

This study is researching an experimental drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery.

The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drugs

  • How much of each study drug is in the blood at different times

  • Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)

  • How administering the study drugs might affect quality of life

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Patients with newly diagnosed, histologically confirmed, fully resectable stage IIto IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8

  2. For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymphnode sampling is required as defined in the protocol

  3. All patients must have disease status showing no evidence of distant metastasesdocumented by a complete physical examination and imaging studies performed within 4weeks prior to randomization as defined in the protocol

  4. A patient must have an evaluable Programmed cell death ligand-1 (PD-L1)immunohistochemistry (IHC) result as defined in the protocol

  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  6. Adequate bone marrow, hepatic and kidney function as defined in the protocol

Exclusion

Key Exclusion Criteria:

  1. Any evidence of locally advanced unresectable or metastatic disease as defined inthe protocol

  2. Patients with tumors with known Epidermal growth factor receptor (EGFR) genemutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in theprotocol

  3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) orhepatitis C virus (HCV) infection as defined in the protocol

  4. Treatment with anti-cancer therapy including immunotherapy, chemotherapy,radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvanthormonotherapy used for breast cancer or other hormone-sensitive cancers in longterm remission is allowed.

  5. Patients with a history of myocarditis

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Study Design

Total Participants: 180
Treatment Group(s): 7
Primary Treatment: Pemetrexed
Phase: 2
Study Start date:
July 16, 2024
Estimated Completion Date:
April 19, 2029

Connect with a study center

  • Eastern Health

    Box Hill, Victoria 3128
    Australia

    Active - Recruiting

  • St Vincents Hospital

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • St. Vincent's Hospital

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • St John of God Murdoch Hospital

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • St. John Of God Murdoch Hospital

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Orlandi Oncologia

    Providencia, Metropolitan Region 7500713
    Chile

    Active - Recruiting

  • Clinica Santa Maria

    Santiago, Providencia 7520378
    Chile

    Active - Recruiting

  • Centro de Oncologia de Precision

    Las Condes, Region Metropolitana, Santiago 7560908
    Chile

    Active - Recruiting

  • Clinica Santa Maria

    Providencia, Region Metropolitana, Santiago 7520378
    Chile

    Active - Recruiting

  • Oncocentro APYS

    Vina del Mar, Valparaiso 2520598
    Chile

    Active - Recruiting

  • LTD "High Technology Hospital Medcenter"

    Batumi, Autonomous Republic Of Adjara 6000
    Georgia

    Active - Recruiting

  • Llc Todua Clinic

    Tbilisi, Caucasus 0112
    Georgia

    Active - Recruiting

  • Cancer Center of Adjara

    Batumi, 6000
    Georgia

    Active - Recruiting

  • High Technology Medical Center, University Clinic Tbilisi

    Tbilisi, 0144
    Georgia

    Active - Recruiting

  • Institute of Clinical Oncology

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • Israeli Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • JSC K. Eristavi National Center of Experimental and Clinical Surgery

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • LLC "Todua Clinic"

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • LTD "Multiprofile Clinic Consilium Medulla"

    Tbilisi, 0186
    Georgia

    Active - Recruiting

  • LTD "New Hospitals"

    Tbilisi, 0162
    Georgia

    Active - Recruiting

  • LTD "Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic"

    Tbilisi, 0144
    Georgia

    Active - Recruiting

  • LTD "lnstitute of Clinical Oncology"

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • LTD New Hospitals

    Tbilisi, 0114
    Georgia

    Active - Recruiting

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186
    Georgia

    Active - Recruiting

  • TIM - Tbilisi Institute of Medicine

    Tbilisi, 0160
    Georgia

    Active - Recruiting

  • University of Malaya Medical Centre

    Kuala Lumpur, Negeri / Wilayah Persekutuan 50603
    Malaysia

    Active - Recruiting

  • Hospital Pulau Pinang

    George Town, Pulau Pinang 10990
    Malaysia

    Active - Recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur, Wilayah Persekutuan 50586
    Malaysia

    Active - Recruiting

  • Hospital Umum Sarawak

    Kuching, 93586
    Malaysia

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, Sanmin 807
    Taiwan

    Active - Recruiting

  • Hualien Tzu Chi Hospital

    Hualien City, 97002
    Taiwan

    Active - Recruiting

  • Chung Shan Medical University

    Taichung, 40201
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital

    Taipei, 110301
    Taiwan

    Active - Recruiting

  • Taipei Municipal Wan Fang Hospital

    Taipei, 116
    Taiwan

    Active - Recruiting

  • Tri-Service General Hospital

    Taipei City, 114
    Taiwan

    Active - Recruiting

  • Faculty of Medicine of Sakarya University

    Sakarya, Marmara 54290
    Turkey

    Active - Recruiting

  • Ondokuz Mayıs University

    Kurupelit, Samsun 55139
    Turkey

    Active - Recruiting

  • Gulhane Research And Training Hospital

    Ankara, 06010
    Turkey

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Clermont Oncology Center

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Mid-Florida Hematology & Oncology Centers, PA

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • University of Illinois

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Kansas Cancer Center-Westwood

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Summit Medical Group

    Florham Park, New Jersey 07932
    United States

    Active - Recruiting

  • University of Rochester

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Kaiser Permanente Northwest

    Portland, Oregon 97227
    United States

    Active - Recruiting

  • Virginia Cancer Care Specialist, PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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