Clinical Trials /

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

NCT03693339

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation
  • Official Title: An Open-label, Multicenter, Phase II Study of Capmatinib in Patients With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation

Clinical Trial IDs

  • ORG STUDY ID: STARTER_cMET
  • NCT ID: NCT03693339

Conditions

  • Cancer
  • Lung Cancer Metastatic
  • MET Gene Mutation

Interventions

DrugSynonymsArms
CapmatinibCapmatinib

Purpose

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.

Trial Arms

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

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate
Time Frame: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]
Safety Issue:
Description:ORR is a proportion of patients with a best overall response defined as complete response or partial response by RECIST1.1

Secondary Outcome Measures

Measure:Duration of response
Time Frame: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
Safety Issue:
Description:DOR is calculated as the time from the date of the first document of complete remission (CR) or partial remission (PR) to the first documented preogressive disease (PD) or death due to any cause for patients with PR or CR.
Measure:Progression-free survival
Time Frame: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
Safety Issue:
Description:PFS is defined as time from the first dose of investigational products (IPs) to progression or death due to any cause. OS is defined as time from the first dose of IPs to death due to any cause.
Measure:Overall survival
Time Frame: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
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Asan Medical Center

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