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
NCT ID: NCT05800015
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
950 participants
INTERVENTIONAL
2023-08-08
2031-12-23
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Phase 2 - Arm A
Randomized 1:1:1 fianlimab (higher dose) + cemiplimab + platinum-doublet chemotherapy
fianlimab
Administered intravenously (IV) every 3 weeks (Q3W)
cemiplimab
Administered IV Q3W
Pemetrexed
IV Infusion, Q3W
Paclitaxel
IV Infusion, Q3W
Carboplatin
IV Infusion, Q3W
Cisplatin
IV infusion, Q3W
Phase 2 - Arm B
Randomized 1:1:1 fianlimab (lower dose) + cemiplimab + platinum-doublet chemotherapy
fianlimab
Administered intravenously (IV) every 3 weeks (Q3W)
cemiplimab
Administered IV Q3W
Pemetrexed
IV Infusion, Q3W
Paclitaxel
IV Infusion, Q3W
Carboplatin
IV Infusion, Q3W
Cisplatin
IV infusion, Q3W
Phase 2 - Arm C
Randomized 1:1:1 cemiplimab + platinum-doublet chemotherapy + placebo
cemiplimab
Administered IV Q3W
Pemetrexed
IV Infusion, Q3W
Paclitaxel
IV Infusion, Q3W
Carboplatin
IV Infusion, Q3W
Cisplatin
IV infusion, Q3W
Placebo
IV infusion, Q3W
Phase 3 - Arm A or B
Randomized 1:1 fianlimab (chosen dose) + cemiplimab + platinum-doublet chemotherapy
fianlimab
Administered intravenously (IV) every 3 weeks (Q3W)
cemiplimab
Administered IV Q3W
Pemetrexed
IV Infusion, Q3W
Paclitaxel
IV Infusion, Q3W
Carboplatin
IV Infusion, Q3W
Cisplatin
IV infusion, Q3W
Phase 3 - Arm C
Randomized 1:1 cemiplimab + platinum-doublet chemotherapy + placebo
cemiplimab
Administered IV Q3W
Pemetrexed
IV Infusion, Q3W
Paclitaxel
IV Infusion, Q3W
Carboplatin
IV Infusion, Q3W
Cisplatin
IV infusion, Q3W
Placebo
IV infusion, Q3W
Interventions
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fianlimab
Administered intravenously (IV) every 3 weeks (Q3W)
cemiplimab
Administered IV Q3W
Pemetrexed
IV Infusion, Q3W
Paclitaxel
IV Infusion, Q3W
Carboplatin
IV Infusion, Q3W
Cisplatin
IV infusion, Q3W
Placebo
IV infusion, Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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, 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.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
6. Adequate organ and bone marrow function as defined in the protocol.
Exclusion Criteria
2. 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.
3. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment.
4. 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.
5. 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).
6. 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.
7. 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.
8. 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 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.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Arizona Clinical Research Center
Tucson, Arizona, United States
Yuma Regional Medical Center
Yuma, Arizona, United States
The Oncology Institute of Hope & Innovation
Cerritos, California, United States
Crosson Cancer Institute
Fullerton, California, United States
St. Joseph Hospital Orange
Orange, California, United States
Desert Hematology Oncology Medical Group Incorporated
Rancho Mirage, California, United States
Emad Ibrahim, MD, Inc.
Redlands, California, United States
PIH Health Hospital
Whittier, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
Yale Cancer Center
New Haven, 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
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States
University of Illinois
Chicago, Illinois, United States
Northwest Oncology and Hematology
Rolling Meadows, Illinois, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Capital Health Hopewell Medical Center
Pennington, New Jersey, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
NYU Langone Health Perlmutter Cancer Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Clinical Research Alliance Inc
Westbury, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Thompson Cancer Survival Center (TCSC ) - Downtown
Knoxville, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 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
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Ballarat Regional Integrated Cancer Centre (BRICC)
Ballarat, Victoria, Australia
Bendigo Hospital
Bendigo, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, Australia
British Columbia Cancer Center-Kelowna
Kelowna, British Columbia, Canada
Hopital Cite de la Sante
Laval, Quebec, Canada
LLC High-Tech Hospital Medcenter
Batumi, Adjara, Georgia
Israeli Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
Research Institute of Clinical Medicine
Tbilisi, , Georgia
LTD New Hospitals
Tbilisi, , Georgia
High Technology Medical Center, University Clinic Tbilisi
Tbilisi, , Georgia
LTD Archangel St. Michael Multiprofile Clinical Hospital
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
Sheba Medical Center
Ramat Gan, Central District, 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
Mount Miriam Cancer Hospital
Tanjung Bungah, Pulau Pinang, Malaysia
National Cancer Institute
Putrajaya, Putrajaya, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Hospital Pulau Pinang
Pulau Pinang, , Malaysia
CHA Bundang Medical Center CHA University
Seongnam-si, 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
Gachon University Gil Medical Center
Incheon, Namdong-gu, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Inha University Hospital
Incheon, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Dalin Tzu Chi Hospital
Dalin Town, Chiayi, 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
Lampang Cancer Center
Lampang, Changwat Lampang, Thailand
Adana City Education and Research Hospital
Adana, Yuregir, Turkey (Türkiye)
Countries
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Other Identifiers
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2022-501577-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
R3767-ONC-2236
Identifier Type: -
Identifier Source: org_study_id
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