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)

NCT05785767 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: R3767-ONC-22352022-501483-18-00
• Study Type: interventional
• Target: 850
• Locations: 11 countries
• Sites: 106

Brief 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

Conditions

Advanced Non-Small Cell Lung Cancer

Keywords

Treatment naïve; NSCLC

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR) as assessed by blinded independent central review (BICR), using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

  Phase 2 Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)

  Up to 136 weeks

• Overall survival (OS)

  Phase 3 The time from randomization to the date of death due to any cause

  Up to 5 years

Secondary Outcomes (43)

• Incidence of treatment-emergent adverse events (TEAEs)

  Up to 136 weeks

• Incidence of treatment-related TEAEs

  Up to 136 weeks

• Incidence of serious adverse events (SAEs)

  Up to 136 weeks

• Incidence of adverse events of special interest (AESIs)

  Up to 136 weeks

• Incidence of immune-mediated adverse events (imAEs)

  Up to 136 weeks

Study Arms (3)

A: fianlimab+cemiplimab

EXPERIMENTAL

Phase 2: fianlimab (HD) Phase 3: fianlimab (chosen dose)

Drug: fianlimab; Drug: cemiplimab

B: fianlimab+cemiplimab

EXPERIMENTAL

Phase 2: fianlimab (LD) Phase 3: fianlimab (chosen dose)

Drug: fianlimab; Drug: cemiplimab

C: cemiplimab monotherapy+placebo

EXPERIMENTAL

Phase 2 and Phase 3

Drug: cemiplimab; Drug: Placebo

Interventions

fianlimab DRUG

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

Also known as: REGN3767

A: fianlimab+cemiplimab; B: fianlimab+cemiplimab

cemiplimab DRUG

Q3W as IV co-infusion

Also known as: REGN2810, Libtayo

A: fianlimab+cemiplimab; B: fianlimab+cemiplimab; C: cemiplimab monotherapy+placebo

Placebo DRUG

Q3W as IV co-infusion

C: cemiplimab monotherapy+placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
• Adequate organ and bone marrow function, as described in the protocol.

You may not qualify if:

• Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime.
• 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.
• 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.
• Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment.
• 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.
• 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).
• 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.
• Patients who have received prior systemic therapies are excluded with the exception of the following:
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (106)

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

Emad Ibrahim, MD, Inc.

Redlands, California, 92373, United States

Location

Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Clermont Oncology Center

Clermont, Florida, 34711, United States

Location

Miami Veterans Administration HealthCare System

Miami, Florida, 33125, United States

Location

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

Location

Pinellas Hematology and Oncology

St. Petersburg, Florida, 33709, United States

Location

Tallahassee Memorial Healthcare

Tallahassee, Florida, 32308, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Mercy South

St Louis, Missouri, 63128, United States

Location

St. Vincent Healthcare

Billings, Montana, 59102, United States

Location

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87102, United States

Location

Clinical Research Alliance Inc

Westbury, New York, 11590, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Renovatio Clinical

El Paso, Texas, 79915, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Bon Secours Cancer Institute Richmond

Midlothian, Virginia, 23114, United States

Location

Macquarie University Health Science Center (MQ Health)

Macquarie Park, New South Wales, 2113, Australia

Location

Riverina Cancer Care Centre (RCCC)

Wagga Wagga, New South Wales, 2650, Australia

Location

Southern Medical Day Care Centre

Wollongong, New South Wales, 2500, Australia

Location

Ballarat Regional Integrated Cancer Centre (BRICC)

Ballarat, Victoria, 3350, Australia

Location

Bendigo Hospital

Bendigo, Victoria, 3550, Australia

Location

British Columbia Cancer Center-Kelowna

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Cancer Center of Adjara

Batumi, Adjara, 6000, Georgia

Location

Israeli Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

Research Institute of Clinical Medicine

Tbilisi, 0112, Georgia

Location

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, 0144, Georgia

Location

NNLE New Vision University Hospital

Tbilisi, 0159, Georgia

Location

The Institute of Clinical Oncology

Tbilisi, 0159, Georgia

Location

TIM - Tbilisi Institute of Medicine

Tbilisi, 0160, Georgia

Location

JSC Evex Hospitals - Caraps Medline

Tbilisi, 0179, Georgia

Location

Soroka University Medical Center

Beersheba, Southern District, 84101, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Assuta Medical Centers

Tel Aviv, 6971028, Israel

Location

Hospital Sultan Ismail

Johor Bahru, Johor, 81100, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

Hospital Tengku Ampuan Afzan (HTTA)

Kuantan, Pahang, 25100, Malaysia

Location

National Cancer Institute

Putrajaya, Putrajaya, 62250, Malaysia

Location

Hospital Pulau Pinang

Pulau Pinang, 10990, Malaysia

Location

Gachon University Gil Medical Center

Incheon, Gyeonggi-do, 21565, South Korea

Location

St. Vincents Hospital - The Catholic University of Korea

Suwon, Gyeonggi-do, 16247, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruna, 15706, Spain

Location

Son Espases

Palma, Balearic Islands, 07120, Spain

Location

Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location

Barcelona, Catalonia, 08028, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Vall d'Hebron Barcelona Hospital Campus

Barcelona, 08035, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Hospital De Valme

Seville, 41001, Spain

Location

Dalin Tzu Chi Hospital

Dalin, Chia-Yi, 622, Taiwan

Location

Buddhist Tzu Chi General Hospital

Hualien City, Hualien, 970, Taiwan

Location

Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110301, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Navamindradhiraj University

Dusit, Bangkok, 10300, Thailand

Location

Lampang Cancer Center

Lampang, Changwat Lampang, 52000, Thailand

Location

Prince Of Songkla Hospital, Prince Of Songkhla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Acibadem Adana Hastanesi

Adana, Adana, 1330, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Altındağ, Ankara, 06230, Turkey (Türkiye)

Location

Medipol University Hospital

Istanbul, Bagcilar, 34284, Turkey (Türkiye)

Location

Bursa Uludag University Medical Faculty

Bursa, Gorukle Bursa Turkiye, 16059, Turkey (Türkiye)

Location

Istinye University VMMedical Park Pendik Hospital

Pendik, Istanbul, 34899, Turkey (Türkiye)

Location

Ege University Faculty of Medicine

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Kocaeli University Hospital

Kocaeli, Marmara, 41380, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Faculty of Medicine

Konya, Meram, 42080, Turkey (Türkiye)

Location

Ondokuz Mayıs University

Kurupelit, Samsun, 55139, Turkey (Türkiye)

Location

Gaziantep Medicalpoint Hospital

Gaziantep, Sehitkamil, 27584, Turkey (Türkiye)

Location

Sakarya University

Sakarya, Serdivan, 54050, Turkey (Türkiye)

Location

Adana City Education and Research Hospital

Adana, Yuregir, 1060, Turkey (Türkiye)

Location

Baskent University

Adana, 1123, Turkey (Türkiye)

Location

Ankara Etlik Sehir Hastanesi Ankara Etlik City Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Ankara Yildirim Beyazit Universitesi - Tip Fakultesi

Ankara, 06050, Turkey (Türkiye)

Location

Gazi University

Ankara, 06100, Turkey (Türkiye)

Location

Liv Hospital Ankara

Ankara, 06100, Turkey (Türkiye)

Location

Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

Ankara, 06100, Turkey (Türkiye)

Location

Yuksek Ihtisas Unıversity Medicalpark Hospital

Ankara, 06370, Turkey (Türkiye)

Location

Memorial Ankara Hospital

Ankara, 906520, Turkey (Türkiye)

Location

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

Koc University

Istanbul, 34010, Turkey (Türkiye)

Location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

Memorial Bahcelievler Hospital

Istanbul, 34180, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty

Istanbul, 34450, Turkey (Türkiye)

Location

Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

Istanbul, 81450, Turkey (Türkiye)

Location

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

Izmir, 35110, Turkey (Türkiye)

Location

Izmir Economy University Medical Point Hospital

Izmir, 35325, Turkey (Türkiye)

Location

Vm Medicalpark Hospital

Samsun, 55200, Turkey (Türkiye)

Location

Related Links

• NSCLC (Harmony Peri Op)

MeSH Terms

Interventions

cemiplimab

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): March 11, 2030
• Study Completion (Estimated): February 5, 2032
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

AU (5); US (23); TU (30); TH (6); TW (8); CA (1); ES (9); IL (4); GE (8); MY (5); KR (7)