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

Status: Recruiting
Location: See all (124) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Florida
Clermont Oncology Center
RECRUITING
Clermont
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
Illinois
University of Illinois
RECRUITING
Chicago
Kansas
University of Kansas Cancer Center-Westwood
RECRUITING
Westwood
Michigan
Henry Ford Health System
RECRUITING
Detroit
Missouri
Mercy South
RECRUITING
St Louis
New Jersey
Summit Medical Group
RECRUITING
Florham Park
New York
University of Rochester
RECRUITING
Rochester
Oregon
Kaiser Permanente Northwest
RECRUITING
Portland
Virginia
Virginia Cancer Care Specialist, PC
RECRUITING
Fairfax
Other Locations
Australia
Eastern Health
RECRUITING
Box Hill
St Vincent's Hospital
RECRUITING
Fitzroy
St John of God Murdoch Hospital
RECRUITING
Murdoch
Chile
Centro de Oncologia de Precision
RECRUITING
Las Condes
Orlandi Oncologia
RECRUITING
Providencia
Clinica Santa Maria
RECRUITING
Santiago
Oncocentro APYS
RECRUITING
Viña Del Mar
France
Centre Hospitalier Universitaire (CHU) Bordeaux
RECRUITING
Bordeaux
APHP - Hopital Ambroise Pare
RECRUITING
Boulogne-billancourt
Chi Creteil
RECRUITING
Créteil
CHU Dijon
RECRUITING
Dijon
CHU Limoges
RECRUITING
Limoges
Centre de Oncologie de Gentilly
RECRUITING
Nancy
Centre Hospitalier Universitaire de Nantes Hopital Guillaume et Rene Laennec
RECRUITING
Nantes
Institut de Cancerologie de l'Ouest
RECRUITING
Saint-herblain
Uneos - Hopital R Schuman
RECRUITING
Vantoux
Georgia
Cancer Center of Adjara
RECRUITING
Batumi
High Technology Medical Center, University Clinic Tbilisi
RECRUITING
Tbilisi
Institute of Clinical Oncology
RECRUITING
Tbilisi
Israeli Georgian Medical Research Clinic Helsicore
RECRUITING
Tbilisi
JSC K. Eristavi National Center of Experimental and Clinical Surgery
RECRUITING
Tbilisi
Llc Todua Clinic
RECRUITING
Tbilisi
LTD New Hospitals
RECRUITING
Tbilisi
Multiprofile Clinic Consilium Medulla
RECRUITING
Tbilisi
TIM - Tbilisi Institute of Medicine
RECRUITING
Tbilisi
Germany
Evang. Kliniken Essen-Mitte
RECRUITING
Essen
Klinikum Esslingen
RECRUITING
Esslingen Am Neckar
LungenClinic
RECRUITING
Großhansdorf
Asklepios Klinikum Harburg
RECRUITING
Hamburg
LKI LUngenfachklinik Immenhausen
RECRUITING
Immenhausen
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
RECRUITING
Neuss
Italy
Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
RECRUITING
Alessandria
Centro di Riferimento Oncologico (CRO) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
RECRUITING
Aviano
ASST Ospedale Papa Giovanni XXIII
RECRUITING
Bergamo
FPO- IRCCS, Istituto di Candiolo
RECRUITING
Candiolo
Azienda Ospedaliero-Universitaria Ferrara (AOU Ferrara)
RECRUITING
Ferrara
UOC Oncologia Medica Ospedale Civile di Livorno Azienda Usl Toscana Nord Ovest
RECRUITING
Livorno
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Niguarda Cancer Center
RECRUITING
Milan
UOC Oncoematologia AOU Vanvitelli
RECRUITING
Naples
Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale
RECRUITING
Napoli
Azienda Ospedaliero-Universitaria Maggiore della Carita
RECRUITING
Novara
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Azienda Sanitaria Territoriale di Pesaro e Urbino
RECRUITING
Pesaro
AUSL Piacenza
RECRUITING
Piacenza
Fondazione Policlinico Universitario Campus Bio-Medico
RECRUITING
Roma
Instituto Fisioterapici Ospitalieri (IFO) Istituto Regina Elena
RECRUITING
Rome
Malaysia
Hospital Pulau Pinang
RECRUITING
George Town
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
University of Malaya Medical Centre
RECRUITING
Kuala Lumpur
Hospital Umum Sarawak
RECRUITING
Kuching
Republic of Korea
National Cancer Center
RECRUITING
Gyeonggi-do
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun
Gachon University Gil Medical Center
RECRUITING
Incheon
Inha University Hospital
RECRUITING
Incheon
Asan Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
The Catholic University of Korea St Vincents Hospital
RECRUITING
Suwon
Ulsan University Hospital
RECRUITING
Ulsan
Romania
Institute of Oncology Bucharest
RECRUITING
Bucharest
Sc Focus Lab Plus Srl (Centrul Medical Focus)
RECRUITING
Bucharest
Cardiomed
RECRUITING
Cluj-napoca
Cluj County Clinical Emergency Hospital
RECRUITING
Cluj-napoca
Medisprof Cancer Center
RECRUITING
Cluj-napoca
Oncocenter Oncologie Clinica S.R.L
RECRUITING
Timișoara
Oncomed
RECRUITING
Timișoara
Spain
Althaia - Xarxa Assistencial Universitaria de Manresa - Orde Hospitalaria de Sant Joan de Deu
RECRUITING
Barcelona
Instituto Oncologico Dr Rosell
RECRUITING
Barcelona
IOB Institute of Oncology Quiron
RECRUITING
Barcelona
Hospital Universitario Virgen de la Arrixaca
RECRUITING
El Palmar
Hospital General Universitario Elche
RECRUITING
Elche
Catalan Institute of Oncology
RECRUITING
Girona
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda
RECRUITING
Majadahonda
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Son Espases
RECRUITING
Palma
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Clinico Universitario Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital De Valme
RECRUITING
Seville
Fundacion IVO
RECRUITING
Valencia
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
RECRUITING
Valencia
Alvaro Cunqueiro Hospital
RECRUITING
Vigo
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Hualien Tzu Chi Hospital
RECRUITING
Hualien City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taipei Medical University Shuang Ho Hospital
RECRUITING
New Taipei City
Chung Shan Medical University
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Municipal Wan Fang Hospital
RECRUITING
Taipei
Tri-Service General Hospital
RECRUITING
Taipei
Turkey
Acibadem Adana Hastanesi
RECRUITING
Adana
Adana City Education and Research Hospital
RECRUITING
Adana
Baskent University Adana Turgut Noyan Hospital
RECRUITING
Adana
Ankara University Faculty of Medicine
RECRUITING
Ankara
Gulhane Training and Research Hospital
RECRUITING
Ankara
Hacettepe University Cancer Institute
RECRUITING
Ankara
Liv Hospital Ankara
RECRUITING
Ankara
Memorial Ankara Hospital
RECRUITING
Ankara
Ege University Faculty of Medicine
RECRUITING
Bornova
Medical Point Gaziantep Hastanesi
RECRUITING
Gaziantep
Bezmialem Vakif University
RECRUITING
Istanbul
Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital
RECRUITING
Istanbul
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
RECRUITING
Istanbul
Koc University
RECRUITING
Istanbul
Kocaeli University Hospital
RECRUITING
Kocaeli
Necmettin Erbakan University Meram Faculty of Medicine
RECRUITING
Konya
Ondokuz Mayıs University
RECRUITING
Kurupelit
Faculty of Medicine of Sakarya University
RECRUITING
Sakarya
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2029-04-19
Participants
Target number of participants: 180
Treatments
Experimental: Arm A
Randomized 1:1:1~Neoadjuvant period:~placebo + cemiplimab + platinum doublet chemotherapy~Adjuvant period:~placebo + cemiplimab
Experimental: Arm B
Randomized 1:1:1~Neoadjuvant period:~fianlimab high dose + cemiplimab + platinum doublet chemotherapy~Adjuvant period:~fianlimab high dose + cemiplimab
Experimental: Arm C
Randomized 1:1:1~Neoadjuvant period:~fianlimab low dose + cemiplimab + platinum doublet chemotherapy~Adjuvant Period:~fianlimab low dose + cemiplimab
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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