Clinical trial • Phase I/II • Oncology
CAPMATINIB for Unresectable metastatic non-small cell lung cancer
Phase I/II trial of CAPMATINIB for Unresectable metastatic non-small cell lung cancer. None/Not specified-controlled, adaptive. 107 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Unresectable metastatic non-small cell lung cancer
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 25-03-2024
- First CTIS Authorization Date
- 03-05-2024
Trial design
None/Not specified-controlled, adaptive Phase I/II trial in Italy, Poland, Spain and others.
- Comparator
- None/Not specified
- Adaptive
- True, Phase 1 dose-finding/dose-escalation to identify the RP2CD(s) of the amivantamab and capmatinib combination (dose selection followed by Phase 2 expansion). No detailed escalation rules or stopping rules provided in the source JSON.
- Biomarker Stratified
- True, biomarker: MET (strata: MET exon 14 skipping mutation; MET amplified NSCLC)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 107
Eligibility
Recruits 107 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information sheets (SIS) and informed consent forms (ICF) are available (multiple country- and site-specific SIS/ICF documents listed for IT, PL, ES, FR, DE) including documents titled 'Privacy Family' and 'Pregnant partner' and withdrawal/partner appendices. Informed consent is obtained using SIS and ICF documents; no assent process for minors is described in the provided materials..
- Pregnancy Exclusion
- 5. 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
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information sheets (SIS) and informed consent forms (ICF) are available (multiple country- and site-specific SIS/ICF documents listed for IT, PL, ES, FR, DE) including documents titled 'Privacy Family' and 'Pregnant partner' and withdrawal/partner appendices. Informed consent is obtained using SIS and ICF documents; no assent process for minors is described in the provided materials.
Inclusion criteria
- {"criterion_text":"- 1. Previously diagnosed with histologically or cytologically confirmed unresectable Stage IV (metastatic) non-small cell lung cancer (NSCLC) (any histology)\n- 2. 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\n- 3. 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)\n- 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n- 5. 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
- {"criterion_text":"- 1. 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\n- 2. Participant has impairment of the gastrointestinal function that could affect absorption of capmatinib or is unable or unwilling to swallow tablets\n- 3. 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\n- 4. 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"}
Endpoints
Primary endpoints
- {"endpoint_text":"- For Phase 1 Combination Dose Selection: - Incidence and Severity of AEs, including Dose Limiting Toxicities (DLTs)\n- For Phase 2 Expansion: - Objective response rate (ORR) according to RECIST v1.1 by investigator review; confirmatory analysis may be performed using blinded independent central review (BICR)","definition_or_measurement_approach":"Phase 1: Measured as incidence and severity of adverse events (AEs), including assessment of dose limiting toxicities (DLTs). Phase 2: Objective response rate (ORR) assessed according to RECIST v1.1 by investigator review; a confirmatory analysis may be performed using blinded independent central review (BICR)."}
Recruitment
- Planned Sample Size
- 107
- Recruitment Window Months
- 53
- Consent Approach
- Informed consent obtained from adult participants using subject information sheets (SIS) and informed consent forms (ICF). Country- and site-specific SIS/ICF documents are available in multiple languages (Italian, Polish, Spanish, French, German, English as indicated by document titles). Additional consent-related documents include pregnancy ICF, partner/pregnant partner forms, privacy appendices and withdrawal forms.
Methods
- Recruitment arrangements and materials documented: country-specific recruitment brochures and K1/K2 recruitment materials (titles present for IT, PL, ES, FR, DE).
- Advertisements (documented for Spain: 'REDACTED_K2_Recruitment material_Advertisement_ES_ES_61186372PANSC2001').
- Investigator talking points (documented for Spain).
- ICF flip charts and patient brochures for use in site recruitment/consent discussions (country-specific).
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 38
Italy
- Earliest CTIS Part Ii Submission Date
- 07-03-2024
- Latest Decision Or Authorization Date
- 17-12-2025
- Processing Time Days
- 650
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- S.C. Oncologia Falck
- Contact Person Name
- Diego Signorelli
- Contact Person Email
- diego.signorelli@ospedaleniguarda.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- UU. OO. di Oncologia di Ravenna, Faenza e Lugo
- Contact Person Name
- Manolo D'arcangelo
- Contact Person Email
- manolo.darcangelo@auslromagna.it
Poland
- Earliest CTIS Part Ii Submission Date
- 07-03-2024
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 655
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Osrodek Badan Klinicznych Wczesnych Faz
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- rafald@gumed.edu.pl
- Site Name
- Instytut Genetyki I Immunologii Genim Sp. z o.o.
- Contact Person Name
- Izabela Chmielewska
- Contact Person Email
- izachm@wp.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oddział Zachowawczy Kliniki Nowotworów Płuca i Klatki Piersiowej
- Contact Person Name
- Dariusz Kowalski
- Contact Person Email
- Dariusz.Kowalski@pib-nio.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 07-03-2024
- Latest Decision Or Authorization Date
- 19-12-2025
- Processing Time Days
- 652
- Number Of Sites
- 11
- Number Of Participants
- 1
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Contact Person Name
- Victor Moreno
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Del Mar
- Department Name
- Medical Oncology
- Contact Person Name
- Edurne Arriola Aperribay
- Contact Person Email
- earriola@psmar.cat
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Medical Oncology
- Contact Person Name
- Maria Amelia Insa Mollá
- Contact Person Email
- ameliainsamolla@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Medical Oncology
- Contact Person Name
- Francisco Javier De Castro Carpeño
- Contact Person Email
- javier.decastro@salud.madrid.org
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Medical Oncology
- Contact Person Name
- Andrés Aguilar
- Contact Person Email
- aaguilar@oncorosell.com
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Medical Oncology
- Contact Person Name
- Bartomeu Massuti Sureda
- Contact Person Email
- massuti.oncoalicante@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Medical Oncology
- Contact Person Name
- Maria del Carmen Damas Fuentes
- Contact Person Email
- carmendamasf@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Contact Person Name
- Luis Paz-Ares Rodriguez
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Medical Oncology
- Contact Person Name
- Maria del Rosario Garcia Campelo
- Contact Person Email
- ma.rosario.garcia.campelo@sergas.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Contact Person Name
- Noemi Reguart Aransay
- Contact Person Email
- NREGUART@clinic.cat
France
- Earliest CTIS Part Ii Submission Date
- 07-03-2024
- Latest Decision Or Authorization Date
- 19-12-2025
- Processing Time Days
- 652
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Department of Pulmonology
- Contact Person Name
- Celine Mascaux
- Contact Person Email
- celine.mascaux@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
- Contact Person Name
- Pascale Tomasini
- Contact Person Email
- pascale.tomasini@ap-hm.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncology
- Contact Person Name
- Sandrine Hiret
- Contact Person Email
- secr.dr.hiret.nantes@ico.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Pulmonology and Thoracic Oncology
- Contact Person Name
- Alexis Cortot
- Contact Person Email
- alexis.cortot@chru-lille.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 07-03-2024
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 753
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- Technische Universitaet Dresden
- Department Name
- Pulmonary Oncology
- Contact Person Name
- Felix Saalfeld
- Contact Person Email
- felix.saalfeld@ukdd.de
- Site Name
- Klinikum Chemnitz gGmbH
- Department Name
- Innere Medizin
- Contact Person Name
- Stefan Hammerschmidt
- Contact Person Email
- s.hammerschmidt@skc.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Haematologie, Onkologie & Tumorimmunologie
- Contact Person Name
- Sebastian Ochsenreither
- Contact Person Email
- sebastian.ochsenreither@charite.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Innere Medizin
- Contact Person Name
- Juergen Wolf
- Contact Person Email
- juergen.wolf@uk-koeln.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Pulmonary Oncology
- Contact Person Name
- Marcel Wiesweg
- Contact Person Email
- marcel.wiesweg@uk-essen.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Hematology, Oncology and Pneumology
- Contact Person Name
- Annalen Bleckmann
- Contact Person Email
- annalen.bleckmann@ukmuenster.de
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Name
- Bioclinica Inc.
- Responsibilities
- Central Imaging collection & reading services
- Name
- Almac Clinical Technologies LLC
- Name
- Labcorp Central Laboratory Services LP
Third parties
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging collection & reading services","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- INC280
- Active Substance
- CAPMATINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Investigational Product Name
- JNJ-61186372
- Active Substance
- AMIVANTAMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Combination Treatment
- Yes
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