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New drug combo targets Hard-to-Treat lung cancer

NCT ID NCT05488314

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests a combination of two drugs, amivantamab and capmatinib, in people with advanced non-small cell lung cancer that has spread. The goal is to find the best dose and see if the combination shrinks tumors. About 57 participants will be enrolled, and the study is currently active but not recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amivantamab and capmatinib
What this could lead to
If successful, this combination could offer a new treatment option for people with a specific type of advanced lung cancer (MET-altered NSCLC).
What could go wrong
This is an early-phase trial with only 57 participants, so results may not apply broadly. Side effects could be significant, and the combination may not work better than existing therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

57 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Ankara Bilkent City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Ankara Bilkent Sehir Hastanesi

    Çankaya, 06800, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • CHU de la Timone

    Marseille, 13005, France

  • CIONC Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810 050, Brazil

  • Charite Universitaetsmedizin Berlin

    Berlin, 12203, Germany

  • Chongqing University Cancer Hospital

    Chongqing, 400030, China

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    Naples, 80131, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900, Brazil

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gazi University Hospital

    Ankara, 06560, Turkey (Türkiye)

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Univ A Coruna

    A Coruña, 15006, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010, Spain

  • Hosp. Del Mar

    Barcelona, 08003, Spain

  • Hosp. Gral. Univ. de Alicante

    Alicante, 03010, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028, Spain

  • Hosp. Virgen Macarena

    Seville, 41009, Spain

  • Huizhou Municipal Central Hospital

    Huizhou, 516001, China

  • INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o

    Lublin, 20 609, Poland

  • Imperial College London and Imperial College Healthcare NHS Trust

    London, W2 1NY, United Kingdom

  • Institut de cancerologie de l'ouest

    Saint-Herblain, 44805, France

  • Institute Coeur Poumon

    Lille, 59000, France

  • Instituto D Or de Pesquisa e Ensino IDOR

    Rio de Janeiro, 22281 100, Brazil

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00128, Italy

  • Istituto Oncologico Veneto - IRCCS

    Padova, 35128, Italy

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116, Germany

  • Montefiore Einstein Center for Cancer Care

    The Bronx, New York, 10467, United States

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02 781, Poland

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001, Japan

  • Nouvel Hopital Civil - CHU Strasbourg

    Strasbourg, 67091, France

  • Nucleo de Oncologia da Bahia

    Salvador, 40170 110, Brazil

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22 250 905, Brazil

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121, Italy

  • PERSONAL Oncologia de Precisao e Personalizada

    Belo Horizonte, 30130-090, Brazil

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 1Z5, Canada

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310009, China

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai Pulmonary Hospital

    Shanghai, 200433, China

  • Shengjing Hospital Of China Medical University

    Shenyang, 110055, China

  • Shizuoka Cancer Center

    Sunto Gun, 411 8777, Japan

  • Sichuan Cancer Hospital

    Chengdu, 610041, China

  • Sir Bobby Robson Cancer Trials Research Centre

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016, China

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901, Brazil

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550, Japan

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510060, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061, China

  • The Oncology Institute of Hope and Innovation

    Cerritos, California, 90703, United States

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario, K1Y 4E9, Canada

  • UCLA

    Los Angeles, California, 90095, United States

  • UPCO Unidade de Pesquisa Clinica em Oncologia

    Pelotas, 96020 080, Brazil

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

    Porto Alegre, 90610-000, Brazil

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2PG, United Kingdom

  • University of Alabama at Birmingham, Comprehensive Cancer Center

    Birmingham, Alabama, 35233, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214, Poland

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • West China Hospital Sichuan University

    Chengdu, 610041, China

  • Yantai Yuhuangding Hospital

    Yantai, 264000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.