CancerPhase 2NCT03693339
Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation
A Phase 2 study testing Capmatinib in people with Cancer and Lung Cancer Metastatic, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung Cancer Metastatic, MET Gene Mutation
- What is being tested?
- Capmatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Oct 2018to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Sang-We Kim, Prof., 82-2-3010-5923, swkim@amc.seoul.kr
About this study
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
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
- Being tested
- Capmatinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapmatinibDrug
Capmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle)
| Study group | Role | What they receive |
|---|---|---|
| Capmatinib | Experimental | Capmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle) Receives: Drug: Capmatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
ORR is a proportion of patients with a best overall response defined as complete response or partial response by RECIST1.1
Measured: 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
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.
Measured: 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
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.
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start30 Oct 2018 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-We Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693339
- Sponsor's protocol ID
- STARTER_cMET
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03693339
- Acronym / sponsor ID
- STARTER_cMET
- Conditions
- Cancer, Lung Cancer Metastatic, MET Gene Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 30 Oct 2018 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capmatinib | Experimental | Drug: CapmatinibCapmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapmatinibCapmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle) | Drug | Capmatinib |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capmatinib in people with Cancer and Lung Cancer Metastatic, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.