None listed
Conditions
Interventions
Drug : IP will be administered orally. Each daily dose of capmatinib is 400 mg bid. Capmatinib should be taken at least one hour before or two hours after a meal. One cycle of treatment is on 28 days.
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. ECOG performance status of 0 to 2 3. Male or female >=18 4. Subjects with measurable lesion (using RECIST 1.1 criteria) 5. Subjects must have archival tissue sample available, collected either at the time of diagnosis of NSCLC or any time since 6. If patients received chemotherapy, such patients must have progressed during or after the last chemotherapy regimen received prior to the first dose of Capmatinib. 7. Patients who is treatment naive or who have progressed during or after 1st line or 2nd line therapy prior to the first dose of capmatinib. 8. 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. Subjects who meet the following criteria: - Absolute neutrophil count (ANC) ?1.5 x 109/L - Platelet count?100 x 109/L - Serum creatinine ?1.5 x upper limit of normal (ULN) - AST (SGOT) and ALT (SGPT) ? 3 x upper limit of normal (ULN) (If there is Liver Metastasis ? 5 x upper limit of normal (ULN)) - Total bilirubin?1.5 x upper limit of normal (ULN) 9. Patients with asymptomatic brain metastasis could be eligible 10. Provision of written informed consent prior to any study specific procedures
Exclusion criteria
Exclusion criteria: 1.Any unresolved chronic toxicity greater than CTC grade 2 from previous anti-cancer treatment 2. Patients who harboring two or more actionable mutation 3. Any major operation or irradiation within 4 weeks of baseline disease assessment 4. Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug 5. Patients who have received exceeding 2 lines of prior systemic therapy, which include chemo, immune and targeted therapy 6. 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 7. Other co-existing malignancies or malignancies diagnosed within the last 3years with the exception of basal cell carcinoma or cervical cancer in situ. 8. Subjects with an uncontrolled major cardiovascular disease (including AMI ithin 12 months, unstable angina within 6 months, over NYHA class III,congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension) 9. Patients with known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of drug pneumonitis, hypersensitivity pneumonitis, obliterative bronchiolitis, and clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention). 10. Pregnant or lactating female 11. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study 12. Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with IPs for the duration of participation: - Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (please refer to http://www.azcert.org/medical- pros/drug-lists/drug-lists.cfm) - Strong and moderate inhibitors of CYP3A4 - Strong inducers of CYP3A4 - Proton pump inhibitors (PPI) - Unstable or increasing doses of corticosteroids - enzyme-inducing anticonvulsive agents - Herbal supplements 13. Patients who have received thoracic radiotherapy to lung fields = 4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs), radiotherapy = 2 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions = 2weeks prior to starting study treatment is allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives: To identify objective response rate of capmatinib in the NSCLC patients with MET exon 14 skipping mutation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: To identify DoR(Duration of Response ), PFS(progression free survival), OS(overall survival), DCR(disease control rate), toxicity, acquired resistance mechanisms ' | — |
Countries
Korea, Republic of
Contacts
Public ContactSangwe Kim
Asan Medical Center
Outcome results
None listed