None listed
Conditions
Interventions
Drug : Clinical trials are oral medications. Daily doses are 150 mg twice daily for dabrafenib and 2 mg daily for trametinib. Drugs are taken 1 hour before meals or 2 hours after meals. A daily dose o
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 a V600E/K BRAF mutation, as per NGS 2· ECOG performance status of 0 to 2 3· 18 = Male or female;<= 80 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· Patients who have progressed during or after 1st line or 2nd or 3rd line therapy prior to the first dose of dabrafenib/trametinib. 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. 7· Subjects who meet the following criteria: - Absolute neutrophil count (ANC) ³1.5 x 109/L - Platelet count³100 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) 8· Patients with asymptomatic brain metastasis could be eligible 9· Provision of written informed consent prior to any study specific procedures.
Exclusion criteria
Exclusion criteria: 1 Any major operation or irradiation within 4 weeks of baseline disease assessment 2 Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug 3 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 4 Subjects with chemotherapy naïve or those who already had received exceeding three lines of chemotherapy including immunotherapy or targeted therapy. 5 Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ. 6 Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, abnormal left ventricular ejection fraction, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension) 7 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). 8 Pregnant or lactating female 9 Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study 10 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 inhibitors or strong inducers of CYP2C8 and CYP3A4 - Unstable or increasing doses of corticosteroids - enzyme-inducing anticonvulsive agents - herbal supplements 11 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 12 Having disease or history of retinal vein occlusion 13 History of previous treatment with BRAF inhibitor or MEK inhibitor 14 Hypersensitivity reaction to the major constituent of the investigational product. 15 Patients who are under other clinical study
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, PFS, OS, DCR, toxicity, acquired resistance mechanisms | — |
Countries
Korea, Republic of
Contacts
Public ContactShinkyo Yoon
Asan Medical Center
Outcome results
None listed