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

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ClinicalTrials.gov Identifier: NCT03693339
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Sang-We Kim, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Cancer Lung Cancer Metastatic MET Gene Mutation Drug: Capmatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 30, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Capmatinib

Arm Intervention/treatment
Experimental: Capmatinib
Capmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle)
Drug: Capmatinib
Capmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle)




Primary Outcome Measures :
  1. 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] ]
    ORR is a proportion of patients with a best overall response defined as complete response or partial response by RECIST1.1


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]

    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.


  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693339


Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Sang-We Kim, Prof.    82-2-3010-5923    swkim@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
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Responsible Party: Sang-We Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03693339    
Other Study ID Numbers: STARTER_cMET
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases