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NCT05488314Active, not recruitingPhase 1/2

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

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
57 (actual)
First submitted
3 Aug 2022
Start date
13 Dec 2022
Primary completion date
28 Apr 2027
Lead sponsor
Janssen Research & Development, LLC
Diseases
Lung cancer
NCT number
NCT05488314
EU CT number
2023-508256-19-00
EudraCT number
2022-000485-18

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 57
  • From 13 Dec 2022 to the primary completion date, 28 Apr 2027
  • 65 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Participant has impairment of the gastrointestinal function that could affect absorption of capmatinib or is unable or unwilling to swallow tablets

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (65)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
PERSONAL Oncologia de Precisao e Personalizada
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Belo HorizonteBrazilUnknown status
CIONC-Centro Integrado de Oncologia de Curitiba
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CuritibaBrazilUnknown status
UPCO Unidade de Pesquisa Clinica em Oncologia
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PelotasBrazilUnknown status
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Porto AlegreBrazilUnknown status
Oncoclinicas Rio de Janeiro S A
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Rio de JaneiroBrazilUnknown status
Instituto D Or de Pesquisa e Ensino IDOR
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Rio de JaneiroBrazilUnknown status
Nucleo de Oncologia da Bahia
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SalvadorBrazilUnknown status
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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São PauloBrazilUnknown status
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilUnknown status
The Ottawa Hospital Research Institute
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OttawaCanadaUnknown status
Princess Margaret Cancer Centre - University Health Network
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TorontoCanadaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Sichuan Cancer Hospital
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ChengduChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Second Affiliated Hospital, School of Medicine, Zhejiang University
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Huizhou Municipal Central Hospital
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HuizhouChinaUnknown status
Shanghai Pulmonary Hospital
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ShanghaiChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaUnknown status
Yantai Yuhuangding Hospital
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YantaiChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital General Universitario Dr. Balmis
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AlicanteSpainCompleted
Hospital del Mar
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BarcelonaSpainCompleted
Hospital Universitari Dexeus Grupo Quironsalud
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceActive, not recruiting
University College London Hospitals NHS Foundation Trust
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LondonUnited KingdomUnknown status
Imperial College London and Imperial College Healthcare NHS Trust
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LondonUnited KingdomUnknown status
Sir Bobby Robson Cancer Trials Research Centre
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Newcastle upon TyneUnited KingdomUnknown status
Royal Marsden Hospital
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SuttonUnited KingdomUnknown status
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyActive, not recruiting
National Hospital Organization Nagoya Medical Center
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NagoyaJapanUnknown status
Shizuoka Cancer Center
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Sunto-gunJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeongnamSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
University of Alabama at Birmingham, Comprehensive Cancer Center
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BirminghamUnited StatesUnknown status
The Oncology Institute of Hope and Innovation
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CerritosUnited StatesUnknown status
Virginia Cancer Specialists
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FairfaxUnited StatesUnknown status
UCLA
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Los AngelesUnited StatesUnknown status
Montefiore Einstein Center for Cancer Care
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The BronxUnited StatesUnknown status
Ankara Bilkent City Hospital
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AnkaraTurkey (Türkiye)Unknown status
Gazi University Hospital
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent Sehir Hastanesi
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ÇankayaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.