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NCT06161441 | RECRUITING | Resectable Non-small Cell Lung Cancer

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
Sponsor:

Regeneron Pharmaceuticals

Brief 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

Condition or disease

Resectable Non-small Cell Lung Cancer

Intervention/treatment

Fianlimab

Cemiplimab

Pemetrexed

Paclitaxel

Carboplatin

Cisplatin

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC
Actual Study Start Date : 2024-07-16
Estimated Primary Completion Date : 2025-09-28
Estimated Study Completion Date : 2029-04-19

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • 1. Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8
  • 2. For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol
  • 3. All patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks 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
  • Key Exclusion Criteria
    • 1. Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol
    • 2. Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol
    • 3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis 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. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
    • 5. Patients with a history of myocarditis
    • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
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

Location Details

NCT06161441

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama at Birmingham

Birmingham, Albama, United States, 35294

RECRUITING

United States, Florida

Clermont Oncology Center

Clermont, Florida, United States, 34711

RECRUITING

United States, Florida

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States, 32763

RECRUITING

United States, Illinois

University of Illinois

Chicago, Illinois, United States, 60612

RECRUITING

United States, Kansas

University of Kansas Cancer Center-Westwood

Westwood, Kansas, United States, 66205

RECRUITING

United States, Road cancer

Henry Ford Health System

Detroit, Road cancer, United States, 48202

RECRUITING

United States, New Jersey

Summit Medical Group

Florham Park, New Jersey, United States, 07932

RECRUITING

United States, New York

University of Rochester

Rochester, New York, United States, 14642

RECRUITING

United States, Oregon

Kaiser Permanente Northwest

Portland, Oregon, United States, 97227

RECRUITING

United States, Virginia

Virginia Cancer Care Specialist, PC

Fairfax, Virginia, United States, 22031

RECRUITING

Australia, Victoria

Eastern Health

Box Hill, Victoria, Australia, 3128

RECRUITING

Australia, Victoria

St Vincents Hospital

Fitzra, Victoria, Australia, 3065

RECRUITING

Australia, Western Australia

St John of God Murdoch Hospital

Murdoch, Western Australia, Australia, 6150

RECRUITING

Chile, Metropolitan Region

Orlandi Oncology

Providence, Metropolitan Region, Chile, 7500713

RECRUITING

Chile, Providence

CLINICA SANTA MARIA

Santiago, Providence, Chile, 7520378

RECRUITING

Chile, Metropolitan Region, Santiago

Precision Oncologia Center

Las Condes, Region Metro, Santiago, Chile, 7560908

RECRUITING

Chile, Valparaiso

Oncocentro APYS

Vina del Mar, Valparaiso, Chile, 2520598

RECRUITING

Georgia, Caucasus

Llc Todua Clinic

Tbilisi, Caucasus, Georgia, 0112

RECRUITING

Georgia,

Cancer Center of Adjara

Batumi, Georgia, 6000

RECRUITING

Georgia,

Israeli Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia, 0112

RECRUITING

Georgia,

LTD New Hospitals

Tbilisi, Georgia, 0114

RECRUITING

Georgia,

High Technology Medical Center, University Clinic Tbilisi

Tbilisi, Georgia, 0144

RECRUITING

Georgia,

Institute of Clinical Oncology

Tbilisi, Georgia, 0159

RECRUITING

Georgia,

JSC K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, Georgia, 0159

RECRUITING

Georgia,

TIM - Tbilisi Institute of Medicine

Tbilisi, Georgia, 0160

RECRUITING

Georgia,

Multiprofile clinic policy spinal

Tbilisi, Georgia, 0186

RECRUITING

Malaysia, State / Federal Territory

University of Malaya Medical Centre

Kuala Lumpur, State / Federal Territory, Malaysia, 50603

RECRUITING

Malaysia, Penang

Penang Hospital

George Town, Penang, Malaysia, 10990

RECRUITING

Malaysia, Federal

Kuala Lumpur Hospital

Kuala Lumpur, Federal Territory, Malaysia, 50586

RECRUITING

Malaysia,

Sarawak General Hospital

Kuching, Malaysia, 93586

RECRUITING

Taiwan, Sanmin

Medical University Chunng-Hospital

composed, Sanmin, Taiwan, 807

RECRUITING

Taiwan,

Hualien Tzu Chi Hospital

Hualien City, Taiwan, 97002

RECRUITING

Taiwan,

Chung Shan Medical University

Taichung, Taiwan, 40201

RECRUITING

Taiwan,

Tri-Service General Hospital

Taipei City, Taiwan, 114

RECRUITING

Taiwan,

Taipei Medical University Hospital

Taipei, Taiwan, 110301

RECRUITING

Taiwan,

Taipei Municipal Wan Fang Hospital

Taipei, Taiwan, 116

RECRUITING

Turkey, Marmara

Faculty of Medicine of Sakarya University

Sakarya, Marmara, Turkey, 54290

RECRUITING

Turkey, Samsun

Ondokuz Mayıs University

Dogedolit, Samsun, Turkey, 55139

RECRUITING

Turkey,

Gulhane Research And Training Hospital

Ankara, Turkey, 06010