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

Primary Purpose

Cancer, Lung Cancer Metastatic, MET Gene Mutation

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Capmatinib

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capmatinib

Arm Description

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

Outcomes

Primary Outcome Measures

Objective response rate

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

Secondary Outcome Measures

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.

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.

Overall survival

Full Information

NCT ID

NCT03693339

First Posted

October 1, 2018

Last Updated

October 1, 2018

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03693339

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 30, 2018 (Anticipated)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Lung Cancer Metastatic, MET Gene Mutation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Capmatinib

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Capmatinib

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective response rate

Description

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

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]

Secondary Outcome Measure Information:

Title

Duration of response

Description

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

Title

Progression-free survival

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.

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sang-We Kim, Prof.

Phone

82-2-3010-5923

swkim@amc.seoul.kr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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