A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
NCT ID: NCT05488314
Last Updated: 2025-11-10
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
PHASE1/PHASE2
57 participants
INTERVENTIONAL
2022-12-13
2028-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1 (Combination Dose Selection)
Participants will receive capmatinib 400 milligrams (mg) orally twice daily from Cycle 1 Day 1, in combination with amivantamab 700 mg intravenous (IV) infusion (for body weight less than 80 kilograms \[kg\]) or 1050 mg IV infusion (for body weight greater than or equal to 80 kg) once weekly from Cycle 1 Day 1 for 4 weeks and then every 2 weeks from Week 5 (Cycle 2; each cycle of 28 days). Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined by the study evaluation team (SET).
Capmatinib
Capmatinib will be administered orally.
Amivantamab
Amivantamab will be administered as IV infusion.
Phase 2 (Dose Expansion)
Participants with mesenchymal-epithelial transition (MET) exon 14 skipping mutation who are treatment naïve (Cohort 1A), who have received prior therapy (Cohort 1B), or participants with MET amplification who have received prior therapy (Cohort 1C) will receive capmatinib in combination with amivantamab at the RP2CD determined by the SET in Phase 1.
Capmatinib
Capmatinib will be administered orally.
Amivantamab
Amivantamab will be administered as IV infusion.
Interventions
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Capmatinib
Capmatinib will be administered orally.
Amivantamab
Amivantamab will be administered as IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* May have: definitively, locally treated brain metastases that are clinically stable and asymptomatic for greater than (\>) 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to \[\<=\]10 milligrams (mg) prednisone or equivalent) for at least 2 weeks prior to start of study treatment
* May have a prior malignancy (other than the disease under study) the natural history or treatment of which is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Exclusion Criteria
* Participant has impairment of the gastrointestinal function that could affect absorption of capmatinib or is unable or unwilling to swallow tablets
* Participant has symptomatic central nervous system (CNS) metastases which are neurologically unstable or have required increasing doses of steroids \>10 mg prednisone or equivalent within the 2 weeks prior to study entry to manage CNS symptoms
* Participant has uncontrolled tumor-related pain: Symptomatic lesions amenable to palliative radiotherapy (example, bone metastases, or metastases causing nerve impingement) should be treated more than 7 days prior to the administration of the first study treatment
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
Napoli, , Italy
Istituto Oncologico Veneto - IRCCS
Padua, , 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 Hospital
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 City Hospital
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
Countries
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Other Identifiers
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61186372PANSC2001
Identifier Type: OTHER
Identifier Source: secondary_id
2022-000485-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508256-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109260
Identifier Type: -
Identifier Source: org_study_id