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)
NCT ID: NCT05785767
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
850 participants
INTERVENTIONAL
2023-06-30
2032-02-05
Brief Summary
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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
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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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A: fianlimab+cemiplimab
Phase 2: fianlimab (HD) Phase 3: fianlimab (chosen dose)
fianlimab
Every three weeks (Q3W) as intravenous (IV) co-infusion
cemiplimab
Q3W as IV co-infusion
B: fianlimab+cemiplimab
Phase 2: fianlimab (LD) Phase 3: fianlimab (chosen dose)
fianlimab
Every three weeks (Q3W) as intravenous (IV) co-infusion
cemiplimab
Q3W as IV co-infusion
C: cemiplimab monotherapy+placebo
Phase 2 and Phase 3
cemiplimab
Q3W as IV co-infusion
Placebo
Q3W as IV co-infusion
Interventions
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fianlimab
Every three weeks (Q3W) as intravenous (IV) co-infusion
cemiplimab
Q3W as IV co-infusion
Placebo
Q3W as IV co-infusion
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 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.
Exclusion Criteria
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.
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
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)
Countries
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Related Links
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NSCLC (Harmony Peri Op)
Other Identifiers
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2022-501483-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
R3767-ONC-2235
Identifier Type: -
Identifier Source: org_study_id
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