Could a lung cancer drug work for other rare tumors? new trial aims to find out.
NCT ID NCT06988475
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests capmatinib, a drug already approved for certain lung cancers, in adults with rare cancers that have specific MET gene changes. About 30 participants will receive the drug to see if it can shrink tumors or stop them from growing for at least 24 weeks. The goal is to find new uses for existing targeted therapies in hard-to-treat cancers.
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 06 (CAPMATINIB) OUTLINED BELOW\* \*When capmatinib-specific inclusion/exclusion criteria or precautions below differ from those specified in the Master Protocol, the capmatinib-specific criteria will take precedence. Inclusion criteria: A. Confirmed diagnosis of a MET-positive malignancy using an analytically next-generation sequencing method (METex14 skipping, MET amplification, MET fusion, or MET activating mutation). B. Adult patients ≥18 years old. C. Women of childbearing potential are eligible, provided that they meet the following criteria: * Have a negative serum or urine pregnancy test before enrolment, and * Agree to use one form of highly effective birth control method (a method that can achieve a failure rate of \<1% when used consistently and correctly), such as: I. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \[oral, intravaginal or transdermal\]) II. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) III. intrauterine device (IUD) IV. Intrauterine hormone-releasing system (IUS) V. bilateral tubal occlusion VI. vasectomised partner VII. sexual abstinence Effective from the first administration of capmatinib, throughout the trial and for seven days after the last administration of capmatinib. D. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from first administration of capmatinib, throughout the trial and for seven days after the last administration of capmatinib: * Agree to take measures not to father children by using a barrier method of contraception (e.g. condom) or sexual abstinence. * Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception, as in criterion C above. * Male patients with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom) to prevent drug exposure of the foetus or neonate. All male patients must refrain from donating sperm for the same period. E. Patients must be able and willing to undergo a fresh biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and/or trephine or lymph node biopsy samples may be taken. F. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility. Exclusion criteria: A. Diagnosis of NSCLC with METex14 skipping mutation or MET amplification. B. Prior treatment with a selective MET inhibitor or HGF-targeting therapy unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to capmatinib. C. Carcinomatous meningitis. D. Presence or history of additional malignant disease that has been diagnosed and/or required therapy within the past three years. Exceptions to this exclusion include: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type. E. Presence or history of interstitial lung disease (ILD) and/or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention) and evidence of active pneumonitis on screening chest computed tomography (CT) scan. Prior localised radiotherapy related pneumonitis is permitted if resolved and off steroids and asymptomatic for at least six months. F. Clinically significant, uncontrolled heart disease such as: * Unstable angina within three months prior to screening * Myocardial infarction within three months prior to screening * History of documented congestive heart failure (New York Heart Association functional classification III-IV) * Uncontrolled hypertension defined by a systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening. Patients with a cerebrovascular event (including stroke or transient ischaemic attack \[TIA\]) within three months before screening. • Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within two weeks of the first dose of capmatinib, and patients with punctate CNS haemorrhages \<3 mm may be considered. G. History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the trial such as: * Concomitant clinically significant cardiac arrhythmias (atrial and ventricular), e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker * History of familial long QT syndrome or known family history of Torsades de Pointes * Resting QTcF (Corrected QT interval by Fridericia formula) ≥450 msec (male) or ≥460 msec (female) at screening ECG (as a mean of triplicate ECG) H. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within four weeks prior to starting trial treatment (two weeks for resection of brain lesions) or patients who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can be enrolled in the trial at least one week after the procedure. I. Patients receiving treatment with strong inducers of cytochrome P450 (CYP) 3A that cannot be discontinued at least one week prior to the start of treatment with capmatinib and for the duration of the trial. J. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial. K. Any impairment of gastrointestinal (GI) function or GI disease that may significantly alter the administration or absorption of capmatinib (e.g., Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome). Unable to swallow capmatinib intact, without chewing or crushing the tablets (as per the dosing schedule). L. Active infections including, but not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Screening for known chronic conditions is not required. Patients with known serological evidence of chronic HBV or HCV infection whose disease is controlled under antiviral therapy according to local regulation are eligible. Patients with history of testing positive for human immunodeficiency virus (HIV) infection are eligible provided the each of the following conditions are met: * CD4 count ≥350/μL; * undetectable viral load; * receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and * no HIV/ acquired immune deficiency syndrome-associated opportunistic infection in the last 12 months. M. Known hypersensitivity to any of the excipients of capmatinib. N. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the two weeks prior to trial entry to manage CNS symptoms. Primary brain or CNS malignancies are allowed providing the patient is clinically stable (if corticosteroids are required, they must be at a stable or decreasing dose for at least 14 days prior to Cycle 1 Day 1). If patients are on corticosteroids for endocrine deficiencies or tumour-associated symptoms other than CNS related, the dose must have been stabilised (or decreasing) for at least five days before Cycle 1 Day 1. O. Patients receiving treatment with any enzyme-inducing anticonvulsant that cannot be discontinued at least one week before first dose of capmatinib, and for the duration of the trial. Patients on non-enzyme-inducing anticonvulsants are eligible. P. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for seven days following their last dose of capmatinib. Q. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during capmatinib treatment or within six months after the final dose of capmatinib.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
17 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Addenbrooke's Hospital
NOT_YET_RECRUITINGCambridge, CB2 OQQ, United Kingdom
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Belfast City Hospital
RECRUITINGBelfast, BT9 7AB, United Kingdom
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Bristol Haematology and Oncology Centre
RECRUITINGBristol, BS2 8ED, United Kingdom
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Churchill Hospital
RECRUITINGOxford, OX3 7LE, United Kingdom
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Clatterbridge Cancer Centre
RECRUITINGMetropolitan Borough of Wirral, CH63 4JY, United Kingdom
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Freeman Hospital
RECRUITINGNewcastle, NE7 7DN, United Kingdom
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Guy's Hospital
RECRUITINGLondon, SE1 9RT, United Kingdom
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Leicester Royal Infirmary
RECRUITINGLeicester, LE1 5WW, United Kingdom
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Royal Marsden Hospital
RECRUITINGSutton, SM2 5PT, United Kingdom
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Southampton General Hospital
RECRUITINGSouthampton, SO16 6YD, United Kingdom
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The Beatson Hospital
RECRUITINGGlasgow, G12 OYN, United Kingdom
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The Christie Hospital
RECRUITINGManchester, M20 4BX, United Kingdom
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University College London Hospital
RECRUITINGLondon, NW1 2BU, United Kingdom
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University Hospital Birmingham
RECRUITINGBirmingham, B15 2TT, United Kingdom
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Velindre Cancer Centre
RECRUITINGCardiff, CF14 2TL, United Kingdom
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Western General Hospital
RECRUITINGEdinburgh, EH4 2XU, United Kingdom
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Western Park Hospital
RECRUITINGSheffield, S10 2SJ, United Kingdom
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