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Tyrosine Kinase Inhibitor
Capmatinib for Non-Small Cell Lung Cancer with Brain Metastasis
Phase 2
Recruiting
Led By Timothy F Burns, MD, PhD
Research Sponsored by Timothy Burns, MD, PHD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug for people with NSCLC that has spread to their brain and have MET amplification.
Who is the study for?
Adults over 18 with advanced non-squamous NSCLC, brain metastases detectable by MRI, and positive MET alterations in cfDNA. They must be able to consent, have an ECOG status of 0 or 1, adequate organ function, a life expectancy of at least 3 months, and no prior MET inhibitor therapy. Patients with symptomatic brain metastases or other recent malignancies are excluded.Check my eligibility
What is being tested?
The trial is testing Capmatinib's effectiveness on brain tumors in patients with NSCLC who have specific genetic changes (MET amplification or mutation). It's a phase II study where all participants receive the drug to see how well it works against cancer that has spread to the brain.See study design
What are the potential side effects?
Capmatinib may cause side effects such as swelling in the lungs (pneumonitis), liver issues, blood count changes leading to increased infection risk or bleeding problems. There might also be gastrointestinal disturbances affecting absorption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CNS Overall response rate (CORR) in
Secondary outcome measures
Adverse Events (AEs)
CNS Duration of response (DOR)
CNS Overall response rate (CORR) (in cfDNA MET ex14 positive)
+6 moreSide effects data
From 2023 Phase 2 trial • 373 Patients • NCT0241413972%
Oedema peripheral
47%
Nausea
38%
Blood creatinine increased
25%
Hypocalcaemia
22%
Lipase increased
22%
Back pain
19%
Insomnia
19%
Fatigue
19%
Dyspnoea
19%
Asthenia
19%
Vomiting
19%
Decreased appetite
19%
Weight decreased
16%
Hypoacusis
16%
Hypoalbuminaemia
16%
Hypotension
16%
Amylase increased
13%
Pyrexia
13%
Dizziness
13%
Diarrhoea
13%
Hypokalaemia
9%
Alopecia
9%
Muscle spasms
9%
Thrombocytopenia
9%
Oedema
9%
COVID-19
9%
Blood alkaline phosphatase increased
9%
Pain in extremity
9%
Epistaxis
9%
Cough
9%
Rash
9%
Abdominal pain
9%
Abdominal pain upper
9%
Constipation
9%
Peripheral swelling
9%
Alanine aminotransferase increased
9%
Neutrophil count decreased
9%
Neuropathy peripheral
6%
Blood bilirubin increased
6%
Muscular weakness
6%
Pruritus
6%
Pleurisy
6%
Productive cough
6%
Pleural effusion
6%
Palpitations
6%
Dyspepsia
6%
Fall
6%
Erysipelas
6%
Epididymitis
6%
Arthralgia
6%
Pulmonary embolism
6%
Dermatitis acneiform
6%
Skin lesion
6%
Superficial vein thrombosis
6%
Deep vein thrombosis
6%
Hyperthyroidism
6%
Anaemia
6%
Cardiac failure
6%
Stomatitis
6%
Gastrooesophageal reflux disease
6%
Generalised oedema
6%
Blood albumin decreased
6%
Pneumonia
6%
Urinary tract infection
6%
Nasopharyngitis
6%
Aspartate aminotransferase increased
6%
Lymphocyte count decreased
6%
C-reactive protein increased
6%
Weight increased
6%
Hyponatraemia
6%
Hypomagnesaemia
6%
Paraesthesia
6%
Dysgeusia
6%
Depression
3%
Rhinitis allergic
3%
Anxiety
3%
Adenocarcinoma gastric
3%
Rhinorrhoea
3%
Embolism
3%
Cardiopulmonary failure
3%
Ascites
3%
General physical health deterioration
3%
Sacroiliitis
3%
Pneumonitis
3%
Peripheral ischaemia
3%
Atrial fibrillation
3%
Upper respiratory tract infection
3%
Oral candidiasis
3%
Influenza
3%
Musculoskeletal chest pain
3%
Oedema genital
3%
Headache
3%
Hypertension
3%
Dry skin
3%
Dehydration
3%
Bone pain
3%
Cerebrovascular accident
3%
Tumour pain
3%
Confusional state
3%
Organic brain syndrome
3%
Tinnitus
3%
Dysphagia
3%
Pain
3%
Contrast media allergy
3%
Liver function test increased
3%
Platelet count decreased
3%
Protein total decreased
3%
White blood cell count decreased
3%
Hyperkalaemia
3%
Neck pain
3%
Taste disorder
3%
Haemoptysis
3%
Dyspnoea exertional
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 7 (Expansion of Cohort 5b): On-treatment
Cohort 5b: Post-treatment Efficacy/Survival Follow-up Period
Cohort 6.2 (Expansion of Cohort 4): On-treatment
Cohort 4 + Cohort 6.2: On-treatment
Cohort 3: Post-treatment Efficacy/Survival Follow-up Period
Cohort 4: Post-treatment Efficacy/Survival Follow-up Period
Cohort 2: On-treatment
Cohort 5a: Post-treatment Efficacy/Survival Follow-up Period
Cohort 1a: On-treatment
Cohort 6.1 (Expansion of Cohort 1a): Post-treatment Efficacy/Survival Follow-up Period
Cohort 7 (Expansion of Cohort 5b): Post-treatment Efficacy/Survival Follow-up Period
Cohort 1b: On-treatment
Cohort 6.2 (Expansion of Cohort 4): Post-treatment Efficacy/Survival Follow-up Period
All Patients: Post-treatment Efficacy/Survival Follow-up
Cohort 3: On-treatment
Cohort 4: On-treatment
Cohort 6.1 (Expansion of Cohort 1a): On-treatment
Cohort 5b: On-treatment
Cohort 5b + Cohort 7: On-treatment
All Patients: On-treatment
Cohort 5a: On-treatment
Cohort 1b: Post-treatment Efficacy/Survival Follow-up Period
Cohort 5b + Cohort 7: Post-treatment Efficacy/Survival Follow-up Period
Cohort 1a: Post-treatment Efficacy/Survival Follow-up
Cohort 2: Post-treatment Efficacy/Survival Follow-up Period
Cohort 4 + Cohort 6.2: Post-treatment Efficacy/Survival Follow-up Period
Trial Design
1Treatment groups
Experimental Treatment
Group I: CapmatinibExperimental Treatment1 Intervention
400 mg orally, twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capmatinib
2021
Completed Phase 3
~570
Find a Location
Who is running the clinical trial?
Timothy Burns, MD, PHDLead Sponsor
Timothy BurnsLead Sponsor
NovartisIndustry Sponsor
1,613 Previous Clinical Trials
2,721,233 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any cancer other than NSCLC or required treatment for another cancer in the last 3 years.My cancer has specific genetic changes that could respond to targeted therapy.I am using reliable birth control methods if I can become pregnant.I am a sexually active male and will use a condom during treatment and for 7 days after.I haven't had cancer treatment within the last 4 weeks or 5 half-lives of the drug.I have been treated with MET inhibitors or HGF-targeting therapy before.I have been on a stable or decreasing dose of corticosteroids for at least 1 month.I do not have symptoms from brain metastases or leptomeningeal disease.I can provide tissue samples for testing.I do not have any severe, unmanaged heart conditions.My cancer has a MET mutation or amplification based on a specific blood test.I have or had lung conditions like interstitial lung disease.I am not taking seizure medications that affect enzyme levels, or I can stop them a week before starting the study drug.I do not have any stomach or intestine problems that affect how my body absorbs medication.I have had any number of previous treatments.I have a brain tumor larger than 10mm, no symptoms, and haven't taken steroids for it.I haven't had major surgery in the last 4 weeks or still recovering from one.My blood counts and organ functions are within the required ranges.My lung cancer does not have EGFR mutations or ALK fusions.I have not had chest radiation within the last 4 weeks or still have side effects from it.I am not on strong CYP3A inducers or can stop them before starting the study treatment.I am not taking any medication that is not allowed in the study.My lung cancer is non-squamous and at stage IV.I am willing and able to follow the study's treatment plan and attend all visits.I have not received any live vaccines in the last 30 days.I am older than 18 years.I am fully active or restricted in physically strenuous activity but can do light work.I can sign and agree to follow the study's rules.I've had brain radiation without my cancer getting worse.
Research Study Groups:
This trial has the following groups:- Group 1: Capmatinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process for this research still open?
"According to clinicaltrials.gov, this particular research study is no longer actively seeking participants; its original posting date was December 1st 2022 and it has not been modified since September 30th 2022. However, 642 other trials are now open for recruitment."
Answered by AI
What is the current regulatory status of Capmatinib?
"With the data currently available, Capmatinib recieved a safety score of 2. This reflects its status as a Phase 2 trial; this medication has yet to be proven effective, but there is evidence that it carries minimal risk."
Answered by AI
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