A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery
NCT ID: NCT06161441
Last Updated: 2026-01-12
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
195 participants
INTERVENTIONAL
2024-07-16
2029-11-04
Brief Summary
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The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC.
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 the blood at different times
* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
* How administering the study drugs might affect 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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Arm A
Randomized 1:1:1
Neoadjuvant period:
placebo + cemiplimab + platinum doublet chemotherapy
Adjuvant period:
placebo + cemiplimab
Cemiplimab
Administered IV Q3W
Pemetrexed
Administered IV Q3W
Paclitaxel
Administered IV Q3W
Carboplatin
Administered IV Q3W
Cisplatin
Administered IV Q3W
Placebo
Administered IV Q3W
Arm B
Randomized 1:1:1
Neoadjuvant period:
fianlimab high dose + cemiplimab + platinum doublet chemotherapy
Adjuvant period:
fianlimab high dose + cemiplimab
Fianlimab
Administered intravenously (IV) every 3 weeks (Q3W)
Cemiplimab
Administered IV Q3W
Pemetrexed
Administered IV Q3W
Paclitaxel
Administered IV Q3W
Carboplatin
Administered IV Q3W
Cisplatin
Administered IV Q3W
Arm C
Randomized 1:1:1
Neoadjuvant period:
fianlimab low dose + cemiplimab + platinum doublet chemotherapy
Adjuvant Period:
fianlimab low dose + cemiplimab
Fianlimab
Administered intravenously (IV) every 3 weeks (Q3W)
Cemiplimab
Administered IV Q3W
Pemetrexed
Administered IV Q3W
Paclitaxel
Administered IV Q3W
Carboplatin
Administered IV Q3W
Cisplatin
Administered IV Q3W
Interventions
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Fianlimab
Administered intravenously (IV) every 3 weeks (Q3W)
Cemiplimab
Administered IV Q3W
Pemetrexed
Administered IV Q3W
Paclitaxel
Administered IV Q3W
Carboplatin
Administered IV Q3W
Cisplatin
Administered IV Q3W
Placebo
Administered IV Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol
3. All patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks prior to randomization as defined in the protocol
4. A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate bone marrow, hepatic and kidney function as defined in the protocol
Exclusion Criteria
2. Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol
3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol
4. Treatment with anti-cancer therapy including immunotherapy, chemotherapy, radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
5. Patients with a history of myocarditis
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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Clermont Oncology Center
Clermont, Florida, United States
University of Illinois
Chicago, Illinois, United States
University of Kansas Cancer Center-Westwood
Westwood, Kansas, United States
Henry Ford Health System
Detroit, Michigan, United States
Mercy South
St Louis, Missouri, United States
University of Rochester
Rochester, New York, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Virginia Cancer Care Specialist, PC
Fairfax, Virginia, United States
Eastern Health
Box Hill, Victoria, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, Australia
Orlandi Oncologia
Providencia, Metropolitan Region, Chile
Clinica Santa Maria
Santiago, Providencia, Chile
Centro de Oncologia de Precision
Las Condes, Region Metropolitana, Santiago, Chile
Oncocentro APYS
Viña del Mar, Región de Valparaíso, Chile
Centre de Oncologie de Gentilly
Nancy, Grand Est, France
Institut de Cancerologie de l'Ouest
Saint-Herblain, Nantes, France
Centre Hospitalier Universitaire (CHU) Bordeaux
Bordeaux, Nouvelle-Aquitaine, France
CHU Limoges
Limoges, Nouvelle-Aquitaine, France
APHP - Hopital Ambroise Pare
Boulogne-Billancourt, , France
CHU Dijon
Dijon, , France
Centre Hospitalier Universitaire de Nantes Hopital Guillaume et Rene Laennec
Nantes, , France
Uneos - Hopital R Schuman
Vantoux, , France
Chi Creteil
Créteil, Île-de-France Region, France
Hopital Cochin
Paris, Île-de-France Region, France
Cancer Center of Adjara
Batumi, , Georgia
Israeli Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
Llc Todua Clinic
Tbilisi, , Georgia
LTD New Hospitals
Tbilisi, , Georgia
High Technology Medical Center, University Clinic Tbilisi
Tbilisi, , Georgia
Institute of Clinical Oncology
Tbilisi, , Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, , Georgia
TIM - Tbilisi Institute of Medicine
Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla
Tbilisi, , Georgia
LKI LUngenfachklinik Immenhausen
Immenhausen, Hesse, Germany
Evang. Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany
LungenClinic
Großhansdorf, Schleswig-Holstein, Germany
Klinikum Esslingen
Esslingen am Neckar, , Germany
Universitatsklinium Giesse
Giessen, , Germany
Asklepios Klinikum Harburg
Hamburg, , Germany
Lungenklinik Hemer
Hemer, , Germany
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
Neuss, , Germany
UOC Oncoematologia AOU Vanvitelli
Naples, Campania, Italy
Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale
Napoli, Campania, Italy
Azienda Ospedaliero-Universitaria Ferrara (AOU Ferrara)
Ferrara, Emilia-Romagna, Italy
AUSL Piacenza
Piacenza, Emilia-Romagna, Italy
Careggi University Hospital
Florence, Firenze, Italy
UOC Oncologia Medica Ospedale Civile di Livorno Azienda Usl Toscana Nord Ovest
Livorno, Livorno, Italy
ASST Ospedale Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Milano, Italy
Azienda Sanitaria Territoriale di Pesaro e Urbino
Pesaro, Pesaro And Urbino, Italy
Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, Italy
Centro di Riferimento Oncologico (CRO) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
Aviano, Pordenone, Italy
FPO- IRCCS, Istituto di Candiolo
Candiolo, Turin, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Tuscany, Italy
Istituto Tumori Giovanni Paolo II (Istituto di Ricovero e Cura a Carattere Scientifico Bari)
Bari, , Italy
ASST Cremona
Cremona, , Italy
Niguarda Cancer Center
Milan, , Italy
Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology
Novara, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Instituto Fisioterapici Ospitalieri (IFO) Istituto Regina Elena
Rome, , Italy
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia
Udine, , Italy
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Negeri / Wilayah Persekutuan, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Hospital Umum Sarawak
Kuching, , Malaysia
National Cancer Center
Gyeonggi-do, Gyeonggi-do, South Korea
The Catholic University of Korea St Vincents Hospital
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-Gu, 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
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Hospital General Universitario Elche
Elche, Alicante, Spain
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Son Espases
Palma, Balearic Islands, Spain
IOB Institute of Oncology Quiron
Barcelona, Catalonia, Spain
Instituto Oncologico Dr Rosell
Barcelona, Catalonia, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Alvaro Cunqueiro Hospital
Vigo, Pontevedra, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Althaia - Xarxa Assistencial Universitaria de Manresa - Orde Hospitalaria de Sant Joan de Deu
Barcelona, , Spain
Catalan Institute of Oncology
Girona, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital De Valme
Seville, , Spain
Fundacion IVO
Valencia, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, , Spain
Changhua Christian Hospital
Changhua, Changhua County, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin, Taiwan
Hualien Tzu Chi Hospital
Hualien City, , Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
Chung Shan Medical University
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, , Taiwan
Acibadem Adana Hastanesi
Adana, Adana, Turkey (Türkiye)
Ege University Faculty of Medicine
Bornova, İzmir, Turkey (Türkiye)
Kocaeli University Hospital
Kocaeli, Marmara, Turkey (Türkiye)
Faculty of Medicine of Sakarya University
Sakarya, Marmara, Turkey (Türkiye)
Necmettin Erbakan University Meram Faculty of Medicine
Konya, Meram, Turkey (Türkiye)
Ondokuz Mayıs University
Kurupelit, Samsun, Turkey (Türkiye)
Medical Point Gaziantep Hastanesi
Gaziantep, Sehitkamil, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Yenimahalle, Turkey (Türkiye)
Baskent University Adana Turgut Noyan Hospital
Adana, Yuregir, Turkey (Türkiye)
Adana City Education and Research Hospital
Adana, Yuregir, Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
Hacettepe University Cancer Institute
Ankara, , Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, , Turkey (Türkiye)
Ankara University Faculty of Medicine
Ankara, , Turkey (Türkiye)
Koc University
Istanbul, , Turkey (Türkiye)
Bezmialem Vakif University
Istanbul, , Turkey (Türkiye)
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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2023-505172-29-00
Identifier Type: CTIS
Identifier Source: secondary_id
R3767-ONC-2266
Identifier Type: -
Identifier Source: org_study_id
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