Actively Recruiting
DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations
Led by Cancer Research UK · Updated on 2025-11-24
30
Participants Needed
17
Research Sites
253 weeks
Total Duration
On this page
Sponsors
C
Cancer Research UK
Lead Sponsor
U
University of Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is looking at a drug called capmatinib. Capmatinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Capmatinib works in patients with lung cancer with a particular mutation in their cancer known as a METex14 skipping mutation. Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation or other specific mutations or changes which take place in the MET gene. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.
CONDITIONS
Official Title
DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of a MET-positive cancer using next-generation sequencing (including METex14 skipping, MET amplification, MET fusion, or MET activating mutation).
- Adults aged 18 years or older.
- Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use highly effective birth control during the trial and for seven days after the last dose.
- Male patients with partners of childbearing potential must agree to use barrier contraception or sexual abstinence during the trial and for seven days after the last dose.
- Ability and willingness to undergo a fresh biopsy at baseline and provide blood samples for research.
- Adequate organ function based on blood tests as defined in the protocol.
You will not qualify if you...
- Diagnosis of non-small cell lung cancer with METex14 skipping mutation or MET amplification.
- Prior treatment with selective MET inhibitors or HGF-targeting therapy unless resistance profile suggests sensitivity to capmatinib.
- Carcinomatous meningitis.
- History or presence of other malignant diseases requiring treatment in the last three years, except certain fully resected skin cancers and carcinoma in situ.
- History or evidence of interstitial lung disease, pneumonitis, or active pneumonitis on chest CT scan.
- Significant uncontrolled heart disease including unstable angina, recent heart attack, severe heart failure, or uncontrolled hypertension.
- Cerebrovascular event within three months prior to screening.
- Unstable or symptomatic central nervous system metastases or recent intra-tumoral bleeding.
- Electrocardiogram abnormalities posing safety risk including certain arrhythmias and prolonged QTc interval.
- Major surgery within four weeks prior to treatment (two weeks for brain surgery) or not recovered from surgery side effects.
- Use of strong cytochrome P450 3A inducers that cannot be stopped before treatment.
- Any significant disease or condition that could interfere with trial conduct or drug absorption.
- Gastrointestinal disorders affecting drug administration or absorption or inability to swallow tablets intact.
- Active infections including hepatitis B, hepatitis C, or HIV unless well controlled per specific criteria.
- Known allergy to capmatinib components.
- Pregnant, breastfeeding, or planning pregnancy during the trial or for seven days after last dose.
- Recent use of live attenuated vaccines within 28 days before enrollment or planned during treatment or six months after last dose.
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Trial Site Locations
Total: 17 locations
1
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
2
University Hospital Birmingham
Birmingham, United Kingdom, B15 2TT
Actively Recruiting
3
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
4
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 OQQ
Not Yet Recruiting
5
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
6
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
7
The Beatson Hospital
Glasgow, United Kingdom, G12 OYN
Actively Recruiting
8
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
9
University College London Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
10
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
11
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
12
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
13
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Actively Recruiting
14
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
15
Western Park Hospital
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
16
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
17
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
A
Aida Sarmiento Castro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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