NCT06161441Active, not recruitingPhase 2
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
A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
This study is researching an experimental drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery. 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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 195 (actual)
- First submitted
- 29 Nov 2023
- Start date
- 16 Jul 2024
- Primary completion date
- 24 Aug 2026
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Lung cancer
- NCT number
- NCT06161441
- EU CT number
- 2023-505172-29-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 195
- From 16 Jul 2024 to the primary completion date, 24 Aug 2026
- 130 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol
- Patients with a history of myocarditis
- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Lab values
- Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol
Who the study is looking for
- Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8
- For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol
- 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
- A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, hepatic and kidney function as defined in the protocol
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (130)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eastern Health Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| St. Vincent's Hospital Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| St John of God Murdoch Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Centro de Oncologia de Precision Coordinator of this site? Confirm its status | Las Condes | Chile | Unknown status |
| Orlandi Oncologia Coordinator of this site? Confirm its status | Providencia | Chile | Unknown status |
| Clinica Santa Maria Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Oncocentro Apys Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Klinikum Esslingen GmbH Coordinator of this site? Confirm its status | Esslingen am Neckar | Germany | Active, not recruiting |
| Justus-Liebig-Universitaet Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Active, not recruiting |
| LungenClinic Grosshansdorf GmbH Coordinator of this site? Confirm its status | Grosshansdorf | Germany | Active, not recruiting |
| Asklepios Kliniken Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Coordinator of this site? Confirm its status | Hemer | Germany | Active, not recruiting |
| Lungenfachklinik Immenhausen Coordinator of this site? Confirm its status | Immenhausen | Germany | Active, not recruiting |
| MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH Coordinator of this site? Confirm its status | Neuss | Germany | Active, not recruiting |
| Hospital Universitari Dexeus Grupo Quironsalud Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Quirónsalud Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Active, not recruiting |
| Institut Català d'Oncologia Coordinator of this site? Confirm its status | Girona | Spain | Active, not recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Active, not recruiting |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Coordinator of this site? Confirm its status | Manresa | Spain | Active, not recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Active, not recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Active, not recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Active, not recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Active, not recruiting |
| Institut de Cancerologie de L'Ouest Coordinator of this site? Confirm its status | Angers | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Active, not recruiting |
| Centre Hospitalier Intercommunal Créteil Coordinator of this site? Confirm its status | Créteil | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Active, not recruiting |
| Centre Hospitalier Et Universitaire De Limoges Coordinator of this site? Confirm its status | Limoges Cedex 1 | France | Active, not recruiting |
| Medipole De Nancy Coordinator of this site? Confirm its status | Nancy | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Active, not recruiting |
| Hopitaux Prives De Metz Coordinator of this site? Confirm its status | Vantoux | France | Active, not recruiting |
| Cancer Center of Adjara Coordinator of this site? Confirm its status | Batumi | Georgia | Unknown status |
| TIM - Tbilisi Institute of Medicine Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| LTD "New Hospitals" Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| JSC K. Eristavi National Center of Experimental and Clinical Surgery Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Institute of Clinical Oncology Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| High Technology Medical Center, University Clinic Tbilisi Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Multiprofile Clinic Consilium Medulla Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Llc Todua Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Israeli Georgian Medical Research Clinic Helsicore Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo Coordinator of this site? Confirm its status | Alexandria | Italy | Active, not recruiting |
| Centro di Riferimento Oncologico di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Active, not recruiting |
| Istituto Tumori Bari Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Active, not recruiting |
| Azienda Socio-Sanitaria Territoriale di Cremona Coordinator of this site? Confirm its status | Cremona | Italy | Active, not recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Active, not recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Azienda Unita' Sanitaria Locale Toscana Nord Ovest Coordinator of this site? Confirm its status | Leghorn | Italy | Active, not recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Azienda Sanitaria Territoriale di Pesaro e Urbino Coordinator of this site? Confirm its status | Pesaro | Italy | Active, not recruiting |
| Azienda Unita Sanitaria Locale Di Piacenza Coordinator of this site? Confirm its status | Piacenza | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Active, not recruiting |
| National Cancer Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| The Catholic University of Korea St Vincents Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Hospital Pulau Pinang Coordinator of this site? Confirm its status | George Town | Malaysia | Unknown status |
| Hospital Kuala Lumpur Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| University of Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Umum Sarawak Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Memorial Healthcare International S R L Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| CardioMed S.R.L. Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Medisprof S.R.L. Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Spitalul Clinic Judetean De Urgenta Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Oncomed S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Completed |
| Oncocenter Oncologie Clinica S.R.L Coordinator of this site? Confirm its status | Timișoara | Romania | Completed |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| Hualien Tzu Chi Hospital Coordinator of this site? Confirm its status | Hualien City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Taipei Medical University Shuang Ho Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Chung Shan Medical University Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taipei Municipal Wan Fang Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Medical University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Clermont Oncology Center Coordinator of this site? Confirm its status | Clermont | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Virginia Cancer Care Specialist, PC Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Kaiser Permanente Northwest Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mercy South Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| University of Kansas Cancer Center-Westwood Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
| Acibadem Adana Hastanesi Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Adana City Education and Research Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Baskent University Adana Turgut Noyan Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Memorial Ankara Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Hacettepe University Cancer Institute Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara University Faculty of Medicine Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Liv Hospital Ankara Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Gulhane Training and Research Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ege University Faculty of Medicine Coordinator of this site? Confirm its status | Bornova | Turkey (Türkiye) | Unknown status |
| Medical Point Gaziantep Hastanesi Coordinator of this site? Confirm its status | Gaziantep | Turkey (Türkiye) | Unknown status |
| Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Bezmialem Vakif University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Koc University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Kocaeli University Hospital Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
| Necmettin Erbakan University Meram Faculty of Medicine Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Unknown status |
| Ondokuz Mayıs University Coordinator of this site? Confirm its status | Kurupelit | Turkey (Türkiye) | Unknown status |
| Faculty of Medicine of Sakarya University Coordinator of this site? Confirm its status | Sakarya | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.