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A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable 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\[s\]) of the amivantamab and capmatinib 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 amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).
Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
57
Start Date
2022-12-13
Completion Date
2027-04-28
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Capmatinib
Capmatinib will be administered orally.
Amivantamab
Amivantamab will be administered as IV infusion.
Locations (78)
University of Alabama at Birmingham, Comprehensive Cancer Center
Birmingham, Alabama, United States
The Oncology Institute of Hope and Innovation
Cerritos, California, United States
UCLA
Los Angeles, California, United States
Montefiore Einstein Center for Cancer Care
The Bronx, New York, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, Brazil
CIONC Centro Integrado de Oncologia de Curitiba
Curitiba, Brazil
UPCO Unidade de Pesquisa Clinica em Oncologia
Pelotas, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, Brazil
Nucleo de Oncologia da Bahia
Salvador, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
Beijing Cancer Hospital
Beijing, China
Sichuan Cancer Hospital
Chengdu, China
West China Hospital Sichuan University
Chengdu, China
Chongqing University Cancer Hospital
Chongqing, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Huizhou Municipal Central Hospital
Huizhou, China
Fudan University Shanghai Cancer Center
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
Shengjing Hospital Of China Medical University
Shenyang, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Yantai Yuhuangding Hospital
Yantai, China
Henan Cancer Hospital
Zhengzhou, China
Institute Coeur Poumon
Lille, France
CHU de la Timone
Marseille, France
Institut de cancerologie de l'ouest
Saint-Herblain, France
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg, France
Charite Universitaetsmedizin Berlin
Berlin, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Universitaetsklinikum Koeln
Cologne, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany
Universitaetsklinikum Essen
Essen, Germany
Universitaetsklinikum Muenster
Münster, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, Italy
Istituto Oncologico Veneto - IRCCS
Padova, Italy
Ospedale S. Maria Delle Croci
Ravenna, Italy
Istituto Nazionale Tumori Regina Elena
Rome, Italy
National Hospital Organization Nagoya Medical Center
Nagoya, Japan
Shizuoka Cancer Center
Sunto Gun, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o
Lublin, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Chungbuk National University Hospital
Cheongju-si, South Korea
National Cancer Center
Goyang-si, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hosp Univ A Coruna
A Coruña, Spain
Hosp. Gral. Univ. de Alicante
Alicante, Spain
Hosp. Del Mar
Barcelona, Spain
Hosp. Univ. Quiron Dexeus
Barcelona, Spain
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp Clinic de Barcelona
Barcelona, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp. Univ. La Paz
Madrid, Spain
Hosp. Virgen Macarena
Seville, Spain
Hosp. Clinico Univ. de Valencia
Valencia, Spain
Gazi University Hospital
Ankara, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Çankaya, Turkey (Türkiye)
University College London Hospitals Nhs Foundation Trust
London, United Kingdom
Imperial College London and Imperial College Healthcare NHS Trust
London, United Kingdom
Sir Bobby Robson Cancer Trials Research Centre
Newcastle upon Tyne, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom