A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer

NCT05800015 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: R3767-ONC-22362022-501577-40-00
• Study Type: interventional
• Target: 950
• Locations: 10 countries
• Sites: 76

Brief Summary

This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". 'Investigational' means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, in comparison with cemiplimab and chemotherapy. 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 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

Non-small Cell Lung Cancer

Keywords

NSCLC; Lung cancer; Programmed cell death ligand-1; PD-L1; Lymphocyte-activation gene 3; LAG-3; African descent

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR) as assessed by blinded independent review committee (BICR) using RECIST 1.1

  Phase 2 ORR is defined as 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 Defined as the time from randomization to the date of death due to any cause

  Up to 5 years

Secondary Outcomes (39)

• Incidence of treatment-emergent adverse event (TEAEs)

  Up to 108 weeks

• Incidence of treatment-related TEAEs

  Up to 108 weeks

• Incidence of serious adverse events (SAEs)

  Up to 108 weeks

• Incidence of adverse events of special interest (AESIs)

  Up to 108 weeks

• Incidence of immune-mediated adverse events (imAEs)

  Up to 108 weeks

Study Arms (5)

Phase 2 - Arm A

EXPERIMENTAL

Randomized 1:1:1 fianlimab (higher dose) + cemiplimab + platinum-doublet chemotherapy

Drug: fianlimab; Drug: cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin

Phase 2 - Arm B

EXPERIMENTAL

Randomized 1:1:1 fianlimab (lower dose) + cemiplimab + platinum-doublet chemotherapy

Drug: fianlimab; Drug: cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin

Phase 2 - Arm C

EXPERIMENTAL

Randomized 1:1:1 cemiplimab + platinum-doublet chemotherapy + placebo

Drug: cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Placebo

Phase 3 - Arm A or B

EXPERIMENTAL

Randomized 1:1 fianlimab (chosen dose) + cemiplimab + platinum-doublet chemotherapy

Drug: fianlimab; Drug: cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin

Phase 3 - Arm C

EXPERIMENTAL

Randomized 1:1 cemiplimab + platinum-doublet chemotherapy + placebo

Drug: cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Placebo

Interventions

fianlimab DRUG

Administered intravenously (IV) every 3 weeks (Q3W)

Also known as: REGN3767

Phase 2 - Arm A; Phase 2 - Arm B; Phase 3 - Arm A or B

cemiplimab DRUG

Administered IV Q3W

Also known as: REGN2810, Libtayo

Phase 2 - Arm A; Phase 2 - Arm B; Phase 2 - Arm C; Phase 3 - Arm A or B; Phase 3 - Arm C

Pemetrexed DRUG

IV Infusion, Q3W

Also known as: Alimta

Phase 2 - Arm A; Phase 2 - Arm B; Phase 2 - Arm C; Phase 3 - Arm A or B; Phase 3 - Arm C

Paclitaxel DRUG

IV Infusion, Q3W

Phase 2 - Arm A; Phase 2 - Arm B; Phase 2 - Arm C; Phase 3 - Arm A or B; Phase 3 - Arm C

Carboplatin DRUG

IV Infusion, Q3W

Also known as: Paraplatin

Phase 2 - Arm A; Phase 2 - Arm B; Phase 2 - Arm C; Phase 3 - Arm A or B; Phase 3 - Arm C

Cisplatin DRUG

IV infusion, Q3W

Also known as: Platinol

Phase 2 - Arm A; Phase 2 - Arm B; Phase 2 - Arm C; Phase 3 - Arm A or B; Phase 3 - Arm C

Placebo DRUG

IV infusion, Q3W

Phase 2 - Arm C; Phase 3 - Arm C

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, expression results (regardless of expression level) 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 a valid PD-L1 result, regardless of expression level, using an assay as 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 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 defined in the protocol.

You may not qualify if:

• 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 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 as an adjuvant or neoadjuvant therapy such as 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 (76)

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

The Oncology Institute of Hope & Innovation

Cerritos, California, 90703, United States

Location

Crosson Cancer Institute

Fullerton, California, 92835, United States

Location

St. Joseph Hospital Orange

Orange, California, 92868, United States

Location

Desert Hematology Oncology Medical Group Incorporated

Rancho Mirage, California, 92270, United States

Location

Emad Ibrahim, MD, Inc.

Redlands, California, 92373, United States

Location

PIH Health Hospital

Whittier, California, 90602, United States

Location

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06519, 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

Tallahassee Memorial Healthcare

Tallahassee, Florida, 32308, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Northwest Oncology and Hematology

Rolling Meadows, Illinois, 60008, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Capital Health Hopewell Medical Center

Pennington, New Jersey, 08534, United States

Location

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87102, United States

Location

NYU Langone Health Perlmutter Cancer Center

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Clinical Research Alliance Inc

Westbury, New York, 11590, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Thompson Cancer Survival Center (TCSC ) - Downtown

Knoxville, Tennessee, 37916, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, 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

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

St Vincents Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

St John of God Murdoch Hospital

Murdoch, Western Australia, 6150, Australia

Location

British Columbia Cancer Center-Kelowna

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Hopital Cite de la Sante

Laval, Quebec, H7M 3L9, Canada

Location

LLC High-Tech Hospital Medcenter

Batumi, Adjara, 6000, Georgia

Location

Israeli Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

Research Institute of Clinical Medicine

Tbilisi, 0112, Georgia

Location

LTD New Hospitals

Tbilisi, 0114, Georgia

Location

High Technology Medical Center, University Clinic Tbilisi

Tbilisi, 0144, Georgia

Location

LTD Archangel St. Michael Multiprofile Clinical Hospital

Tbilisi, 0159, 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

Sheba Medical Center

Ramat Gan, Central District, 5265601, 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

Mount Miriam Cancer Hospital

Tanjung Bungah, Pulau Pinang, 11200, Malaysia

Location

National Cancer Institute

Putrajaya, Putrajaya, 62250, Malaysia

Location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

Hospital Pulau Pinang

Pulau Pinang, 10990, Malaysia

Location

CHA Bundang Medical Center CHA University

Seongnam-si, Gyeonggi-do, 13520, 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

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Dalin Tzu Chi Hospital

Dalin Town, Chiayi, 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, 701, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110301, Taiwan

Location

Tri-Service General Hospital

Taipei, 114202, Taiwan

Location

Lampang Cancer Center

Lampang, Changwat Lampang, 52000, Thailand

Location

Adana City Education and Research Hospital

Adana, Yuregir, 1060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

cemiplimab; Pemetrexed; Paclitaxel; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

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 23, 2023
• First Posted: April 5, 2023
• Study Start: August 8, 2023
• Primary Completion (Estimated): January 16, 2030
• Study Completion (Estimated): December 23, 2031
• 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

GE (10); TH (1); MY (7); AU (6); CA (2); TW (8); US (29); TU (1); IL (2); KR (10)