Active Not RecruitingPhase 1 / Phase 2NCT05488314

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

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).

Checked against the public recordLast updated Aug 28, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1 / Phase 2
U.S. locations78
SponsorJanssen Research & Development, LLC
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Janssen Research & Development, LLC
Interventions being studied
Drug: Capmatinib; Drug: Amivantamab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at Birmingham, Comprehensive Cancer CenterBirmingham, Alabama
  • The Oncology Institute of Hope and InnovationCerritos, California
  • UCLALos Angeles, California
  • Montefiore Einstein Center for Cancer CareThe Bronx, New York
  • Virginia Cancer SpecialistsFairfax, Virginia
  • PERSONAL Oncologia de Precisao e PersonalizadaBelo Horizonte
  • CIONC Centro Integrado de Oncologia de CuritibaCuritiba
  • UPCO Unidade de Pesquisa Clinica em OncologiaPelotas
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRSPorto Alegre
  • Oncoclinicas Rio de Janeiro S ARio de Janeiro
  • Instituto D Or de Pesquisa e Ensino IDORRio de Janeiro
  • Nucleo de Oncologia da BahiaSalvador

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 28, 2026. Always confirm current availability with the study team.

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