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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03693339
Other study ID # STARTER_cMET
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 30, 2018
Est. completion date June 30, 2022

Study information

Verified date October 2018
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 27
Est. completion date June 30, 2022
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Duration of response 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. 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 Progression-free survival 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.
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 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
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