Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05785767

PHASE2/PHASE3

A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab (also called REGN2810), individually called a "study drug" or collectively called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab and cemiplimab is in treating advanced NSCLC, in comparison with cemiplimab by itself. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much study drug is in your blood at different times * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects) * How administering the study drugs might improve your quality of life

Official title: A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

850

Start Date

2023-06-30

Completion Date

2032-02-05

Last Updated

2026-01-22

Healthy Volunteers

Conditions

Advanced Non-Small Cell Lung Cancer

Interventions

DRUG

fianlimab

Every three weeks (Q3W) as intravenous (IV) co-infusion

DRUG

cemiplimab

Q3W as IV co-infusion

DRUG

Placebo

Q3W as IV co-infusion

Key Inclusion Criteria: 1. Patients with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC. 2. Availability of an archival or on-study formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample, without intervening therapy between biopsy collection and screening as described in the protocol 3. For enrollment in phase 2, patients should have PD-L1 levels ≥ 50%, as determined by a College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) (or equivalently licensed, according to local regulations) accredited laboratory, as described in the protocol. For enrollment in phase 3, patients should have expression of programmed cell death ligand-1 (PD-L1) in ≥50% of tumor cells stained using an assay performed by a central laboratory, as described in the protocol. 4. At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site. 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. 6. Adequate organ and bone marrow function, as described in the protocol. Key Exclusion Criteria: 1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime. 2. Active or untreated brain metastases or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated, and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Patients must be off (immunosuppressive doses of) corticosteroid therapy. 3. Patients with tumors tested positive for actionable epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or c-ros oncogene 1 (ROS1) fusions, as described in the protocol. 4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment. 5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to enrollment. 6. Known primary immunodeficiencies, either cellular (eg, DiGeorge syndrome, T-cell-negative severe combined immunodeficiency \[SCID\]) or combined T- and B-cell immunodeficiencies (eg, T- and B-cell negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency). 7. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-mediated treatment-emergent adverse events (imTEAEs). Patients with uncontrolled type 1 diabetes mellitus or with uncontrolled adrenal insufficiency are excluded. The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment. 8. Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization. Physiologic replacement doses are allowed even if they are \>10 mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Patients with clinically relevant systemic immune suppression within the last 3 months before trial enrollment are excluded. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder. 9. Patients who have received prior systemic therapies are excluded with the exception of the following: 1. Adjuvant or neoadjuvant platinum-based doublet chemotherapy (after surgery and/or radiation therapy) if recurrent or metastatic disease develops more than 6 months after completing therapy as long as toxicities have resolved to CTCAE grade ≤1 or baseline with the exception of alopecia and peripheral neuropathy. 2. Anti-PD-(L) 1 with or without LAG-3 as an adjuvant or neoadjuvant therapy as long as the last dose is \>12 months prior to enrollment. 3. Prior exposure to other immunomodulatory or vaccine therapies as an adjuvant or neoadjuvant therapy, Cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibodies as long as the last dose is \>6 months prior to enrollment. Immune-mediated AEs must be resolved to CTCAE grade ≤1 or baseline by the time of enrollment. Endocrine immune-mediated AEs controlled with hormonal or other non-immunosuppressive therapies without resolution prior to enrollment are allowed. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.

Locations (106)

Arizona Clinical Research Center

Tucson, Arizona, United States

Yuma Regional Medical Center

Yuma, Arizona, United States

Emad Ibrahim, MD, Inc.

Redlands, California, United States

Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, United States

Clermont Oncology Center

Clermont, Florida, United States

Miami Veterans Administration HealthCare System

Miami, Florida, United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

Pinellas Hematology and Oncology

St. Petersburg, Florida, United States

Tallahassee Memorial Healthcare

Tallahassee, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Illinois

Chicago, Illinois, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Mercy South

St Louis, Missouri, United States

St. Vincent Healthcare

Billings, Montana, United States

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, United States

Clinical Research Alliance Inc

Westbury, New York, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Renovatio Clinical

El Paso, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Bon Secours Cancer Institute Richmond

Midlothian, Virginia, United States

Macquarie University Health Science Center (MQ Health)

Macquarie Park, New South Wales, Australia

Riverina Cancer Care Centre (RCCC)

Wagga Wagga, New South Wales, Australia

Southern Medical Day Care Centre

Wollongong, New South Wales, Australia

Ballarat Regional Integrated Cancer Centre (BRICC)

Ballarat, Victoria, Australia

Bendigo Hospital

Bendigo, Victoria, Australia

British Columbia Cancer Center-Kelowna

Kelowna, British Columbia, Canada

Cancer Center of Adjara

Batumi, Adjara, Georgia

Israeli Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Research Institute of Clinical Medicine

Tbilisi, Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, Georgia

NNLE New Vision University Hospital

Tbilisi, Georgia

The Institute of Clinical Oncology

Tbilisi, Georgia

TIM - Tbilisi Institute of Medicine

Tbilisi, Georgia

JSC Evex Hospitals - Caraps Medline

Tbilisi, Georgia

Soroka University Medical Center

Beersheba, Southern District, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Assuta Medical Centers

Tel Aviv, Israel

Hospital Sultan Ismail

Johor Bahru, Johor, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan (HTTA)

Kuantan, Pahang, Malaysia

National Cancer Institute

Putrajaya, Putrajaya, Malaysia

Hospital Pulau Pinang

Pulau Pinang, Malaysia

Gachon University Gil Medical Center

Incheon, Gyeonggi-do, South Korea

St. Vincents Hospital - The Catholic University of Korea

Suwon, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Korea University Guro Hospital

Seoul, South Korea

Ulsan University Hospital

Ulsan, South Korea

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruna, Spain

Son Espases

Palma, Balearic Islands, Spain

Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location

Barcelona, Catalonia, Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Vall d'Hebron Barcelona Hospital Campus

Barcelona, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Hospital De Valme

Seville, Spain

Dalin Tzu Chi Hospital

Dalin, Chia-Yi, Taiwan

Buddhist Tzu Chi General Hospital

Hualien City, Hualien, Taiwan

Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taipei Medical University - Shuang Ho Hospital

New Taipei City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Navamindradhiraj University

Dusit, Bangkok, Thailand

Lampang Cancer Center

Lampang, Changwat Lampang, Thailand

Prince Of Songkla Hospital, Prince Of Songkhla University

Hat Yai, Changwat Songkhla, Thailand

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Chiang Mai University

Chiang Mai, Thailand

Acibadem Adana Hastanesi

Adana, Adana, Turkey (Türkiye)

Hacettepe University Medical Faculty

Altındağ, Ankara, Turkey (Türkiye)

Medipol University Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Bursa Uludag University Medical Faculty

Bursa, Gorukle Bursa Turkiye, Turkey (Türkiye)

Istinye University VMMedical Park Pendik Hospital

Pendik, Istanbul, Turkey (Türkiye)

Ege University Faculty of Medicine

Bornova, İzmir, Turkey (Türkiye)

Kocaeli University Hospital

Kocaeli, Marmara, Turkey (Türkiye)

Necmettin Erbakan University Meram Faculty of Medicine

Konya, Meram, Turkey (Türkiye)

Ondokuz Mayıs University

Kurupelit, Samsun, Turkey (Türkiye)

Gaziantep Medicalpoint Hospital

Gaziantep, Sehitkamil, Turkey (Türkiye)

Sakarya University

Sakarya, Serdivan, Turkey (Türkiye)

Adana City Education and Research Hospital

Adana, Yuregir, Turkey (Türkiye)

Baskent University

Adana, Turkey (Türkiye)

Ankara Etlik Sehir Hastanesi Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Ankara Yildirim Beyazit Universitesi - Tip Fakultesi

Ankara, Turkey (Türkiye)

Gazi University

Ankara, Turkey (Türkiye)

Liv Hospital Ankara

Ankara, Turkey (Türkiye)

Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

Ankara, Turkey (Türkiye)

Yuksek Ihtisas Unıversity Medicalpark Hospital

Ankara, Turkey (Türkiye)

Memorial Ankara Hospital

Ankara, Turkey (Türkiye)

Trakya University

Edirne, Turkey (Türkiye)

Koc University

Istanbul, Turkey (Türkiye)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Memorial Bahcelievler Hospital

Istanbul, Turkey (Türkiye)

Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

Istanbul, Turkey (Türkiye)

Izmir Dr.Suat Seren Gogus Hastaliklari Ve Cerrahisi Egitim Ve Arastirma Hastanesi

Izmir, Turkey (Türkiye)

Izmir Economy University Medical Point Hospital

Izmir, Turkey (Türkiye)

Vm Medicalpark Hospital

Samsun, Turkey (Türkiye)

Clinical Research Directory

A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (106)