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Carcinoma, Non-Small-Cell LungPhase 1/2METalmarkNCT05488314

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

A Phase 1/2 study testing Capmatinib and Amivantamab in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 78 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Capmatinib and Amivantamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
78 sitesin 13 countries
Study dates
13 Dec 2022to 31 May 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

78 sites in 13 countries.

78 sites in 13 countries

China14 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510060

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310009

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • Huizhou Municipal Central Hospital

    Huizhou, 516001

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • Shengjing Hospital Of China Medical University

    Shenyang, 110055

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

  • Yantai Yuhuangding Hospital

    Yantai, 264000

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Spain11 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp. Gral. Univ. de Alicante

    Alicante, 03010

  • Hosp. Del Mar

    Barcelona, 08003

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Virgen Macarena

    Seville, 41009

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

Other trials in Spain

Brazil9 sites

  • PERSONAL Oncologia de Precisao e Personalizada

    Belo Horizonte, 30130-090

  • CIONC Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810 050

  • UPCO Unidade de Pesquisa Clinica em Oncologia

    Pelotas, 96020 080

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

    Porto Alegre, 90610-000

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22 250 905

  • Instituto D Or de Pesquisa e Ensino IDOR

    Rio de Janeiro, 22281 100

  • Nucleo de Oncologia da Bahia

    Salvador, 40170 110

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

Other trials in Brazil

South Korea8 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • National Cancer Center

    Goyang-si, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Germany6 sites

  • Charite Universitaetsmedizin Berlin

    Berlin, 12203

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Muenster

    Münster, 48149

Other trials in Germany

Italy6 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    Naples, 80131

  • Istituto Oncologico Veneto - IRCCS

    Padova, 35128

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00128

Other trials in Italy

United States5 sites

  • University of Alabama at Birmingham, Comprehensive Cancer Center

    Birmingham, Alabama, 35233

  • The Oncology Institute of Hope and Innovation

    Cerritos, California, 90703

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • UCLA

    Los Angeles, California, 90095

  • Montefiore Einstein Center for Cancer Care

    The Bronx, New York, 10467

Other trials in United States

France4 sites

  • Institute Coeur Poumon

    Lille, 59000

  • CHU de la Timone

    Marseille, 13005

  • Institut de cancerologie de l'ouest

    Saint-Herblain, 44805

  • Nouvel Hopital Civil - CHU Strasbourg

    Strasbourg, 67091

Other trials in France

United Kingdom4 sites

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2PG

  • Imperial College London and Imperial College Healthcare NHS Trust

    London, W2 1NY

  • Sir Bobby Robson Cancer Trials Research Centre

    Newcastle upon Tyne, NE7 7DN

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Japan3 sites

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001

  • Shizuoka Cancer Center

    Sunto Gun, 411 8777

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

Other trials in Japan

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

  • INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o

    Lublin, 20 609

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02 781

Other trials in Poland

Turkey (Türkiye)3 sites

  • Gazi University Hospital

    Ankara, 06560

  • Ankara Bilkent City Hospital

    Ankara, 06800

  • Ankara Bilkent Sehir Hastanesi

    Çankaya, 06800

Other trials in Turkey (Türkiye)

Canada2 sites

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario, K1Y 4E9

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

About this study

Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy 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).

Being tested
Capmatinib, Amivantamab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapmatinibDrug

    Capmatinib will be administered orally.

  • AmivantamabDrug

    Also called JNJ-61186372

    Amivantamab will be administered as IV infusion.

Study groups in NCT05488314
Study groupRoleWhat they receive
Phase 1 (Combination Dose Selection)ExperimentalParticipants 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).
Receives: Drug: Capmatinib; Drug: Amivantamab
Phase 2 (Dose Expansion)ExperimentalParticipants 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.
Receives: Drug: Capmatinib; Drug: Amivantamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Number of Participants with Adverse events (AEs) by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

    Measured: Up to 2 years 1 month

  2. Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)

    The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, hematologic toxicity, pulmonary toxicity, liver enzyme elevation, or treatment delay greater than (>) 28 days due to unresolved toxicity.

    Measured: Cycle 1 (Day 1 through Day 28)

  3. Phase 2: Objective Response Rate

    ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Up to 2 years 1 month

Secondary outcomes (11)

  1. Phase 1: Number of Participants with AEs by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

    Measured: Up to 2 years 1 month

  2. Phase 1: Number of Participants with Abnormalities in Clinical Laboratory Parameters

    Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported.

    Measured: Up to 2 years 1 month

  3. Phase 2: Duration of Response (DoR)

    DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participants who have PR or CR.

    Measured: Up to 2 years 1 month

  4. Phase 2: Disease Control Rate (DCR)

    DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1.

    Measured: Up to 2 years 1 month

  5. Phase 2: Progression Free Survival (PFS)

    PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1

    Measured: Up to 2 years 1 month

  6. Phase 2: Overall Survival (OS)

    OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause.

    Measured: Up to 2 years 1 month

  7. Phase 2: Time to Subsequent Therapy (TTST)

    TTST is defined as the time from the date of administration of the first study treatment to the start date of the subsequent anticancer therapy following study treatment discontinuation, or death, whichever comes first.

    Measured: Up to 2 years 1 month

  8. Phase 2 (Cohort 1A): Change from Baseline in Health-related Quality of Life in (HRQoL) as Assessed by European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score

    EORTC-QLQ-C30 is a self-administered, 30-item questionnaire developed to assess the HRQoL of cancer participants.

    Measured: Baseline up to 2 years 1 month

  9. Phase 2 (Cohort 1A): HRQoL as Assessed by Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ) Scale Score

    NSCLC-SAQ assesses patient-reported symptom severity associated with NSCLC.

    Measured: Up to 2 years 1 month

  10. Phase 2 (Cohort 1A): HRQoL as Assessed by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale Score

    EQ-5D-5L is a self-administered, standardized measure of health status.

    Measured: Up to 2 years 1 month

  11. Phase 2 (Cohort 1A): HRQoL as Assessed by Patient-reported Outcomes Measurement Information System Short Form Version 2.0 - Physical Function 8c (PROMIS PF 8c) Scale Score

    PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It assesses activities of daily living, mobility, and global impact of physical functioning.

    Measured: Up to 2 years 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2022
  2. Study start13 Dec 2022
  3. Primary completion28 Apr 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05488314
Sponsor's protocol ID
CR109260
Other IDs
61186372PANSC2001, 2022-000485-18, 2023-508256-19-00, 2023
Acronym
METalmark
Status last verified
Nov 2026
First submitted
3 Aug 2022
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Capmatinib and Amivantamab in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 78 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in China, Spain, Brazil, South Korea, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Number of Participants with Adverse events (AEs) by Severity (time frame: Up to 2 years 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05488314.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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