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

NCT03693339 | Unknown Phase 2

• 1 other identifier: STARTER_cMET
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  ORR is a proportion of patients with a best overall response defined as complete response or partial response by RECIST1.1

  At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months]

Secondary Outcomes (3)

• Duration of response

  At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

• Progression-free survival

  At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

• Overall survival

  At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

Study Arms (1)

Capmatinib

EXPERIMENTAL

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

Drug: Capmatinib

Interventions

Capmatinib DRUG

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

Capmatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

capmatinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: October 30, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2022
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

KR (1)