Kinase Inhibitor

Capmatinib for Lung Cancer

University of California San Francisco, San Francisco, CA

Targeting 2 different conditionsCapmatinib +1 morePhase 1RecruitingLed by Collin M Blakely, MD, PhDResearch Sponsored by Collin Blakely

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Archived tissue available or willingness to undergo new tumor biopsy

Life expectancy of at least 3 months

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 12 months

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Lung Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You have tissue samples available from a previous biopsy or are willing to undergo a new biopsy of your tumor.

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You are expected to live for at least 3 more months.

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You can participate in this trial if you had cancer in the past, but you are not currently receiving treatment for it and do not have any active cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

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 more

Side effects data

From 2020 Phase 2 trial • 18 Patients • NCT03647488

39%

Nausea

28%

Diarrhoea

28%

Blood creatinine increased

28%

Vomiting

28%

Dyspnoea

22%

Pyrexia

22%

Asthenia

22%

Fatigue

22%

Oedema peripheral

17%

Weight decreased

11%

Anxiety

11%

Pleural effusion

11%

Pruritus

11%

Decreased appetite

11%

Constipation

11%

Lipase increased

11%

Chest pain

11%

Dysphagia

11%

Anaemia

11%

Alanine aminotransferase increased

11%

Lymphocyte count decreased

11%

Aspartate aminotransferase increased

11%

C-reactive protein increased

General physical health deterioration

Hyperglycaemia

Pain in extremity

Cancer pain

Confusional state

Sleep disorder

Dyspnoea exertional

Hyperhidrosis

Haemoptysis

Productive cough

Herpes zoster

Osteomyelitis

Depression

Stress cardiomyopathy

Abdominal pain

Cough

Blood magnesium decreased

Dehydration

Lethargy

Gamma-glutamyltransferase increased

Hypotension

Arthralgia

Hypoalbuminaemia

Pain

Dysgeusia

Pneumonia

Dizziness

Dyspepsia

Dry mouth

Stomatitis

Cardiac failure congestive

Cheilitis

Ventricular arrhythmia

Deep vein thrombosis

Respiratory failure

Eyelid oedema

Drug hypersensitivity

Respiratory tract infection

Bronchial obstruction

Abdominal infection

Anaphylactic reaction

Pericardial effusion

Renal pain

Hypomagnesaemia

Axillary pain

Muscle spasms

Dysphonia

Blood alkaline phosphatase increased

Creatinine renal clearance decreased

Somnolence

Amylase increased

Musculoskeletal chest pain

Headache

Nipple pain

Rash macular

Bronchospasm

100%

80%

60%

40%

20%

Study treatment Arm

Run-in Part: Capmatinib + Spartalizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 either 300 or 400 mg capmatinib orally, twice a day and 1.5 or 2 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

2021

Completed Phase 2

~380

Trametinib

2014

Completed Phase 2

~1600

0 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

Collin BlakelyLead Sponsor

1 Previous Clinical Trials

22 Total Patients Enrolled

NovartisIndustry Sponsor

1,599 Previous Clinical Trials

2,709,102 Total Patients Enrolled

Collin M Blakely, MD, PhDPrincipal Investigator

University of California, San Francisco

Media Library

Capmatinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05435846 — Phase 1

Lung Cancer Research Study Groups: Phase 1b: Dose Expansion, Phase 1: Dose Escalation

Lung Cancer Clinical Trial 2023: Capmatinib Highlights & Side Effects. Trial Name: NCT05435846 — Phase 1

Capmatinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05435846 — Phase 1

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation

Collin Blakely 2022. "Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05435846.