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Kinase Inhibitor
Capmatinib + Trametinib for Non-Small Cell Lung Cancer
Phase 1
Recruiting
Led By Collin M Blakely, MD, PhD
Research Sponsored by Collin Blakely
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Asymptomatic serum amylase =< grade 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing the side effects and best doses of two drugs, capmatinib and trametinib, when given together to treat patients with metastatic non-small cell lung cancer that has a mutation in the MET gene.
Who is the study for?
Adults with a life expectancy of at least 3 months and confirmed non-small cell lung cancer that has spread, with specific MET gene mutations. They must have adequate organ function, no severe liver issues or untreated brain metastases, and agree to use contraception. Prior treatments are allowed but not required.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs, Capmatinib and Trametinib, both kinase inhibitors targeting abnormal proteins in cancer cells. It aims to find the best doses for treating patients with a particular mutation in their lung cancer cells.See study design
What are the potential side effects?
Potential side effects include risks associated with kinase inhibitors such as fatigue, digestive issues, skin reactions, increased blood pressure, vision changes like blurred vision or reduced visual acuity; heart problems including decreased ejection fraction; muscle pain; fever; allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hepatitis B virus is under control with treatment.
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My amylase levels are within normal or slightly elevated.
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My liver enzyme ALT levels are within normal range.
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I had hepatitis C but am cured or my current treatment has made the virus undetectable.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lung cancer is confirmed to be non-small cell type.
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My liver enzyme AST levels are within normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with reported dose limiting toxicity (DLT) (Phase I)
Proportion of participants with treatment-emergent adverse events (Phase Ib)
Secondary outcome measures
Mean Disease Control Rate (DCR) (Phase Ib)
Median Progression Free Survival (PFS) (Phase Ib)
Overall Response Rate (ORR) (Phase Ib)
+2 moreSide effects data
From 2023 Phase 2 trial • 373 Patients • NCT0241413949%
Oedema peripheral
46%
Nausea
32%
Vomiting
26%
Diarrhoea
23%
Constipation
23%
Blood creatinine increased
22%
Decreased appetite
19%
Alanine aminotransferase increased
16%
Dyspnoea
16%
Fatigue
16%
Aspartate aminotransferase increased
13%
Gamma-glutamyltransferase increased
13%
Hypoalbuminaemia
13%
Hypophosphataemia
13%
Dry skin
13%
Amylase increased
13%
Cough
12%
Non-cardiac chest pain
12%
Pyrexia
12%
Back pain
12%
Blood alkaline phosphatase increased
10%
Pruritus
10%
Nasopharyngitis
10%
Pneumonia
10%
Weight decreased
10%
Weight increased
10%
Insomnia
9%
Headache
9%
Pain in extremity
9%
Pleural effusion
9%
Asthenia
9%
Arthralgia
7%
Anaemia
7%
Lipase increased
7%
Hypokalaemia
6%
Muscle spasms
6%
Dysphonia
6%
Pain
6%
Dizziness
6%
Hypertension
6%
Hypotension
6%
Abdominal pain upper
6%
Dyspepsia
6%
Myalgia
4%
Rash
4%
Dysgeusia
4%
General physical health deterioration
4%
Respiratory failure
4%
Gastrooesophageal reflux disease
4%
Cellulitis
4%
Musculoskeletal pain
4%
Pneumonitis
4%
Productive cough
4%
Blood albumin decreased
4%
Blood bilirubin increased
4%
Platelet count decreased
4%
C-reactive protein increased
4%
Neutrophil count decreased
4%
Haemoptysis
3%
Musculoskeletal chest pain
3%
Rash maculo-papular
3%
Neutropenia
3%
Seizure
3%
Atrial fibrillation
3%
Hypoacusis
3%
Cardiac failure
3%
Dysphagia
3%
Hyponatraemia
3%
Vertigo
3%
Abdominal pain
3%
Malaise
3%
White blood cell count decreased
3%
Hypomagnesaemia
3%
Somnolence
3%
Confusional state
1%
Thrombocytopenia
1%
Hepatotoxicity
1%
Pancreatitis acute
1%
Intestinal obstruction
1%
Generalised oedema
1%
Oesophageal stenosis
1%
Lung abscess
1%
Respiratory tract infection
1%
Hyperkalaemia
1%
Acute kidney injury
1%
Tumour pain
1%
Cerebral ischaemia
1%
Renal failure
1%
Breast pain
1%
Pneumothorax
1%
Leukopenia
1%
Jugular vein thrombosis
1%
Superior vena cava syndrome
1%
Palpitations
1%
Tinnitus
1%
Face oedema
1%
Stomatitis
1%
Herpes zoster
1%
Oropharyngeal pain
1%
Dermatitis acneiform
1%
Pulmonary embolism
1%
Rhinorrhoea
1%
Embolism
1%
Duodenitis
1%
Vascular device occlusion
1%
Hepatitis
1%
Influenza
1%
Medical device site infection
1%
Pneumonia bacterial
1%
Femur fracture
1%
Bone pain
1%
Muscular weakness
1%
Hemiparesis
1%
Aphasia
1%
Cerebral mass effect
1%
Epilepsy
1%
Abdominal discomfort
1%
Hyperthyroidism
1%
Oedema
1%
Chest discomfort
1%
Peripheral swelling
1%
Bronchitis
1%
Fall
1%
Spinal compression fracture
1%
Hypercalcaemia
1%
Hypocalcaemia
1%
Sleep disorder
1%
Dysuria
1%
Paraesthesia
1%
Depression
1%
Hypoaesthesia
1%
Neuropathy peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1a: On-treatment
Cohort 2: 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 7 (Expansion of Cohort 5b): On-treatment
Cohort 5a: Post-treatment Efficacy/Survival Follow-up Period
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
2Treatment groups
Experimental Treatment
Group I: Phase 1b: Dose ExpansionExperimental Treatment2 Interventions
Patients will receive the recommended phase 2 dose (RP2D) or capmatinib in combination with trametinib determined by the safety profile of the Phase 1 group. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Phase 1: Dose EscalationExperimental Treatment2 Interventions
Patients receive 200 - 400 mg capmatinib orally, twice a day and 1.0 or 1.5 mg trametinib orally once a day on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capmatinib
FDA approved
Trametinib
FDA approved
Find a Location
Who is running the clinical trial?
Collin BlakelyLead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,721,002 Total Patients Enrolled
Collin M Blakely, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hepatitis B virus is under control with treatment.I had to stop or lower my dose of capmatinib due to side effects.I am not pregnant, as the treatment could harm my unborn baby.You are allergic to capmatinib or trametinib or any of the ingredients in these medications.My amylase levels are within normal or slightly elevated.I agree to use contraception during and for 16 weeks after the study.Your hemoglobin level is at least 9 grams per deciliter.My liver enzyme ALT levels are within normal range.Your lipase levels in the blood are not higher than the normal range.Your total bilirubin level is not too high, except if it's caused by Gilbert's syndrome and your direct bilirubin level is normal.My brain cancer hasn't worsened after treatment and I'm not on steroids.I currently have an active COVID-19 infection.My kidney function is good enough for the trial, with a GFR of at least 30 mL/min.I had hepatitis C but am cured or my current treatment has made the virus undetectable.I have had cancer before, but it's not currently being treated and won't affect this trial.Your creatinine levels are within the normal range for the hospital where you are being treated.I haven't had major surgery in the last 4 weeks or brain surgery in the last 2 weeks, or I've recovered from any side effects.I had to stop or lower my dose of capmatinib due to side effects.I have a history or current case of RVO or RPED in my eyes.I had to stop or lower my dose of capmatinib due to side effects.I am 18 years old or older.Your alkaline phosphatase levels are not more than 5 times the normal limit at the hospital where the study is taking place.My last cancer treatment wasn't specifically for blocking MET.I have a history of heart problems.You have enough white blood cells called neutrophils in your body.I am fully active or restricted in physically strenuous activity but can do light work.I can provide samples from my previous biopsy or am willing to have a new one.My cancer has specific genetic changes in EGFR, KRAS, ALK, ROS1, NTRK, BRAF, RET, or MET.I have taken capmatinib before and tolerated the recommended phase 2 dose well.I have had interstitial lung disease or pneumonitis.I haven't had cancer treatments like chemotherapy, radiation, or targeted therapy in the specified time before starting the study drug.I have HBV, HCV, or HIV with low CD4+ T cell counts or a history of AIDS-related infections.Your platelet count is at least 100,000 per microliter.My lung cancer is confirmed to be non-small cell type.I may or may not have had platinum-based chemotherapy or anti-PD-1/PD-L1 therapy.You have a tumor that can be measured according to specific guidelines.I have recovered from all serious side effects of my previous cancer treatments, except for hair loss.I am not on strong CYP3A inducers, or can stop them before starting the study.My liver enzyme AST levels are within normal range.You have a device implanted in your heart to help with irregular heartbeats.My cancer has a specific mutation (MET exon 14 skipping) and has worsened after treatment with a MET inhibitor.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b: Dose Expansion
- Group 2: Phase 1: Dose Escalation
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
What are the intended outcomes of this experiment?
"As outlined by the clinical trial sponsor, Novartis, this experiment will be gauging its primary outcome -- Proportion of participants with reported dose limiting toxicity (DLT) (Phase I) -- over a 12 month period. Secondary outcomes include: Proportion of participants with treatment-emergent adverse events (Phase I), Overall survival (OS) (Phase Ib), and Median Progression Free Survival (PFS) (Phase Ib). These are respectively defined as proportion of patients exhibiting Adverse Events graded via NCI CTCAE version 5.0 in Phase Ib; 1+ days from first drug dosage to death due to any"
Answered by AI
Are there substantial risks associated with taking Capmatinib?
"As this is an early-stage trial, the safety of capmatinib has been assigned a score of 1. This implies that there exists minimal data on its efficacy and security."
Answered by AI
How many participants will be part of this clinical trial?
"Correct. Details on clinicaltrials.gov confirm that this medical experiment, which was first listed on August 10th 2022, is still enrolling participants. 33 individuals will be accepted from 1 particular site."
Answered by AI
Is recruitment still open for this experiment?
"Per clinicaltrials.gov, this medical research is currently recruiting patients who meet the criteria. This trial was first published on August 10th of 2022 and last modified five days later."
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