Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation

NCT ID: NCT03693339

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2022-06-30

Brief Summary

This study is a phase II, single-arm, open label study under an umbrella trial for NSCLC. This clinical study is targeted for the patients who harbor exon 14 skipping mutation of MET and all patients will be treated with Capmatinib. The treatment period begins on Day 1 of Cycle 1 and 1 cycle consists of 28 days.

Conditions

Cancer; Lung Cancer Metastatic; MET Gene Mutation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capmatinib

Capmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle)

Group Type: EXPERIMENTAL

Capmatinib

Intervention Type: DRUG

Capmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle)

Interventions

Capmatinib

Capmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects with histologically or cytologically confirmed, unresectable stage IIIB/IV NSCLC that carries MET exon 14 skipping alteration by molecular testing, as per NGS and RT PCR.
• ECOG performance status of 0 to 2
• Male or female; ≥ 18
• Subjects with measurable lesion (using RECIST 1.1 criteria)
• Subjects must have archival tissue sample available, collected either at the time of diagnosis of NSCLC or any time since
• Patients who have progressed during or after 1st line or 2nd line therapy prior to the first dose of capmatinib. For patient who have received prior platinum containing adjuvant, neoadjuvant, or definitive chemoradiation for locally advanced disease, those treatments are regarded as 1st line if the progression has occurred < 12 months from last therapy.

Exclusion Criteria

• Any major operation or irradiation within 4 weeks of baseline disease assessment
• Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
• Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
• Patients who have received more than 2 lines of prior systemic therapy, which include chemo, immune and targeted therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sang-We Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Sang-We Kim, Prof.

Role: primary

swkim@amc.seoul.kr

82-2-3010-5923

Other Identifiers

STARTER_cMET

Identifier Type: -

Identifier Source: org_study_id