A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Last updated: April 25, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

N/A

Treatment

Amivantamab

Capmatinib

Clinical Study ID

NCT05488314
CR109260
2022-500729-34-00
2022-000485-18
61186372PANSC2001
2023-508256-19-00
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Previously diagnosed with histologically or cytologically confirmed unresectableStage IV (metastatic) non-small cell lung cancer (NSCLC) (any histology)

  • May have: definitively, locally treated brain metastases that are clinically stableand asymptomatic for greater than (>) 2 weeks and who are off or receiving low-dosecorticosteroid treatment (less than or equal to [<=]10 milligrams (mg) prednisone orequivalent) for at least 2 weeks prior to start of study treatment

  • May have a prior malignancy (other than the disease under study) the natural historyor treatment of which is unlikely to interfere with any study endpoints of safety orthe 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 atscreening and within 72 hours of the first dose of study treatment and must agree tofurther serum or urine pregnancy tests during the study

Exclusion

Exclusion Criteria:

  • Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, orhas current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled outby imaging at screening

  • Participant has impairment of the gastrointestinal function that could affectabsorption of capmatinib or is unable or unwilling to swallow tablets

  • Participant has symptomatic central nervous system (CNS) metastases which areneurologically unstable or have required increasing doses of steroids >10 mgprednisone or equivalent within the 2 weeks prior to study entry to manage CNSsymptoms

  • Participant has uncontrolled tumor-related pain: Symptomatic lesions amenable topalliative radiotherapy (example, bone metastases, or metastases causing nerveimpingement) should be treated more than 7 days prior to the administration of thefirst study treatment

Study Design

Total Participants: 57
Treatment Group(s): 2
Primary Treatment: Amivantamab
Phase: 1/2
Study Start date:
December 13, 2022
Estimated Completion Date:
August 22, 2026

Connect with a study center

  • PERSONAL - Oncologia de Precisão e Personalizada

    Belo Horizonte, 30130-090
    Brazil

    Site Not Available

  • PERSONAL Oncologia de Precisao e Personalizada

    Belo Horizonte, 30130-090
    Brazil

    Site Not Available

  • CIONC - Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810-050
    Brazil

    Site Not Available

  • CIONC Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810 050
    Brazil

    Site Not Available

  • UPCO Unidade de Pesquisa Clinica em Oncologia

    Pelotas, 96020 080
    Brazil

    Site Not Available

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000
    Brazil

    Site Not Available

  • Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000
    Brazil

    Active - Recruiting

  • União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS

    Porto Alegre, 90610-000
    Brazil

    Site Not Available

  • Instituto D Or de Pesquisa e Ensino (IDOR)

    Rio de Janeiro, 22281 100
    Brazil

    Active - Recruiting

  • Instituto D Or de Pesquisa e Ensino IDOR

    Rio de Janeiro, 22281 100
    Brazil

    Site Not Available

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    Rio de Janeiro, 22281-100
    Brazil

    Active - Recruiting

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22 250 905
    Brazil

    Site Not Available

  • Oncoclínicas Rio de Janeiro S.A.

    Rio de Janeiro, 22250-905
    Brazil

    Site Not Available

  • Nucleo de Oncologia da Bahia

    Salvador, 40170 110
    Brazil

    Site Not Available

  • Núcleo de Oncologia da Bahia

    Salvador, 40170-110
    Brazil

    Site Not Available

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    Sao Paulo, 01509 900
    Brazil

    Site Not Available

  • Fundação Antônio Prudente - A.C. Camargo Cancer Center

    Sao Paulo, 01509-010
    Brazil

    Site Not Available

  • Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

    São Paulo, 01308 901
    Brazil

    Site Not Available

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901
    Brazil

    Site Not Available

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario K1Y 4E9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario M5G 1Z5
    Canada

    Site Not Available

  • University Health Network (UHN) Princess Margaret Cancer Centre

    Toronto, Ontario M5G 1Z5
    Canada

    Suspended

  • University Health Network UHN Princess Margaret Cancer Centre

    Toronto, Ontario M5G 1Z5
    Canada

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Site Not Available

  • Sichuan Cancer Hospital

    Chengdu, 610041
    China

    Site Not Available

  • West China Hospital Sichuan University

    Chengdu, 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, 610041
    China

    Active - Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400030
    China

    Site Not Available

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510060
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510060
    China

    Active - Recruiting

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310009
    China

    Site Not Available

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310016
    China

    Site Not Available

  • Harbin medical university cancer hospital

    Harbin, 150081
    China

    Site Not Available

  • Huizhou Municipal Central Hospital

    Huizhou, 516001
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, 200433
    China

    Site Not Available

  • Shengjing Hospital Of China Medical University

    Shenyang, 110055
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'An, 710061
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'An, 710061
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai, 264000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, 450008
    China

    Site Not Available

  • Institute Coeur Poumon

    Lille, 59000
    France

    Site Not Available

  • Centre Leon Bérard

    Lyon Cedex 8, 69008
    France

    Site Not Available

  • CHU de la Timone

    Marseille, 13005
    France

    Site Not Available

  • Institut Curie

    PARIS Cedex 5, 75248
    France

    Site Not Available

  • Institut de cancerologie de l'ouest

    Saint-Herblain Cedex, 44805
    France

    Site Not Available

  • Nouvel Hopital Civil - CHU Strasbourg

    Strasbourg cedex, 67091
    France

    Site Not Available

  • Charite Universitaetsmedizin Berlin

    Berlin, 12203
    Germany

    Site Not Available

  • Helios Klinikum Emil von Behring GmbH

    Berlin, 14165
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Koeln, 50937
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster

    Muenster, 48149
    Germany

    Site Not Available

  • Munchen Klinik GmbH Klinik Bogenhausen

    München, 81925
    Germany

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

    Site Not Available

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    Napoli, 80131
    Italy

    Site Not Available

  • Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

    Napoli, 80131
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto - IRCCS

    Padova, 35128
    Italy

    Site Not Available

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00128
    Italy

    Site Not Available

  • National Hospital Organization Nagoya Medical Center

    Nagoya-shi, 460-0001
    Japan

    Site Not Available

  • Shizuoka Cancer Center

    Sunto Gun, 411 8777
    Japan

    Site Not Available

  • Shizuoka Cancer Center

    Sunto-gun, 411-8777
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550
    Japan

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju-si, 28644
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang-Si, 10408
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Hospital

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214
    Poland

    Site Not Available

  • INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o

    Lublin, 20 609
    Poland

    Site Not Available

  • INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp. z o.o.

    Lublin, 20-609
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warszawa, 02 781
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

    Warszawa, 02-781
    Poland

    Site Not Available

  • Auxilio Mutuo Cancer Center

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Hosp Univ A Coruna

    A Coruna, 15006
    Spain

    Site Not Available

  • Hosp. Univ. A Coruna

    A Coruna, 15006
    Spain

    Site Not Available

  • Hosp. Univ. A Coruna

    A Coruña, 15006
    Spain

    Site Not Available

  • Hosp. Univ. A Coruña

    A Coruña, 15006
    Spain

    Site Not Available

  • Hosp. Gral. Univ. de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hosp Univ Vall D Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hosp. Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp. Del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028
    Spain

    Site Not Available

  • Hosp. Univ. Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hosp. Univ. Fund. Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hosp. Univ. La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hosp. Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Ankara Bilkent City Hospital

    Ankara, 06800
    Turkey

    Site Not Available

  • Gazi University Hospital

    Ankara, 06560
    Turkey

    Site Not Available

  • Liv Hospital Ankara

    Ankara, 06680
    Turkey

    Site Not Available

  • Ankara Bilkent City Hospital

    Cankaya, 06800
    Turkey

    Site Not Available

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098
    Turkey

    Site Not Available

  • Imperial College London and Imperial College Healthcare NHS Trust

    London, W2 1NY
    United Kingdom

    Site Not Available

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • Freeman Hospital

    Newcastle, NE7 7DN
    United Kingdom

    Site Not Available

  • Sir Bobby Robson Cancer Trials Research Centre

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham, Comprehensive Cancer Center

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • The Oncology Institute of Hope and Innovation

    Cerritos, California 90703
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California, Irvine

    Orange, California 92868
    United States

    Site Not Available

  • The Oncology Institute of Hope and Innovation

    Whittier, California 90603
    United States

    Site Not Available

  • H. Lee Moffitt Cancer & Research Institute

    Tampa, Florida 33612
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637-1426
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Montefiore Einstein Center for Cancer Care

    Bronx, New York 10467
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599-1651
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • VCU Medical Center

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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