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A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and cetrelimab combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection); and to evaluate the antitumor effect of the combination at the selected RP2CD in participants with NSCLC characterized on the basis of epidermal growth factor receptor (EGFR) and Programmed-cell death Ligand (PD-L)1 status, in the Phase 2 (expansion).
Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2023-05-18
Completion Date
2027-03-31
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Cetrelimab
Cetrelimab will be administered as IV infusion.
Amivantamab
Amivantamab will be administered as IV infusion.
Locations (43)
City of Hope
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic Westside
Portland, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Fundacao Pio XII
Barretos, Brazil
Cetus Oncologia
Belo Horizonte, Brazil
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, Brazil
CIONC Centro Integrado de Oncologia de Curitiba
Curitiba, Brazil
Hospital do Cancer de Londrina
Londrina, Brazil
Hospital Nossa Senhora da Conceicao S A
Porto Alegre, Brazil
Hospital Santa Izabel Santa Casa de Misericordia da Bahia
Salvador, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
European Institute of Oncology
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Aou San Luigi Gonzaga
Orbassano, Italy
Centro Ricerche Cliniche di Verona S r l
Verona, Italy
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Umum Sarawak
Kuching, Malaysia
INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o
Lublin, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
Poznan, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hosp. Gral. Univ. de Alicante
Alicante, Spain
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp. Univ. Quiron Dexeus
Barcelona, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp. Virgen Macarena
Seville, Spain
Instituto Valenciano de Oncologia
Valencia, Spain
Adana City Hospital
Adana, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey (Türkiye)
Bakirkoy Sadi Konuk Training and Research Hospital
Istanbul, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, Turkey (Türkiye)
Medicana International Izmir
Izmir, Turkey (Türkiye)
Sakarya Universitesi Egitim Ve Arastırma Hastanesi
Sakarya, Turkey (Türkiye)
Imperial College London and Imperial College Healthcare NHS Trust
London, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom