EGFR-TKI treated T790M positive non-small cell lung cancer (NSCLC) with CNS metastasis (radiotherapy-naive)
Conditions
Interventions
Osimertinib at the dose of 80mg/day is orally administered once daily and the administration is continued until progression disease (PD)
Sponsors
Clinical Research Support Center Kyushu
(1)Lung Oncology Group in Kyushu (2) West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically. 2) Patients with EGFR sensitive mutation (del19, L858R) detected in tumour tissue specimen or cytologic specimen. 3) Patients with treatment history of 1st generation and/or 2nd generation EGFR-TKI. 4) Patients with confirmation of EGFR T790M mutation positive after progression disease. 5) Patients with metastatic brain tumour (>= 5mm) with the major axis more than twice the slice width in MRI. However, patients required for urgent radiotherapy or surgical resection are ineligible. 6) Radiotherapy-naive for brain metastasis. 7) Patient is at least 20 years of age (at enrollment date). 8) Performance status (ECOG): 0-2 9) The latest clinical laboratory test within 14 days prior to enrollment (it is eligible on the same day 2 weeks before the enrolment day) meets the following all standard. 1.Neutrophil count >= 1,500/mm3 2.Haemoglobin >= 8.0g/dL 3.Platelet count >=100,000/mm3 4.AST, ALT <=100 IU/L 5.Total bilirubin <=1.5mg/dL 6.Creatinine<=1.5mg/dL 7.SpO2 >= 90% 10) Corrected QT interval (QTc) <= 470 msec. 11) Patients with life expectancy of at least 3 months. 12) Patients providing the written informed consent.
Exclusion criteria
Exclusion criteria: 1) Symptomatic brain metastasis required for radiation therapy or surgical resection. 2) Patients with severe complication: such as myocardial infarction within 3 months, uncontrollable angina pectoris and heart failure 3) Patients with active double cancer (synchronous double cancer and asynchronous double cancer within 5 years of progression-free period. However, the lesions correspondent to carcinoma in situ and intramucosal carcinoma curable by topical treatment are excluded) 4) Treatment history of anti-PD-1 antibody, anti-PD-L1 antibody, anti- CD137 antibody or anti-CTLA-4 antibody. 5) Patients with pregnant or possibly pregnant. 6) Patients with nursing. 7) History of interstitial pulmonary disease, drug-induced interstitial pulmonary disease and irradiation pneumonitis required for steroidal treatment. 8) Urgent radiotherapy because of symptom of superior vena cava syndrome. 9) Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom. 10) Any other patients who are regarded as unsuitable for this study by the investigators. 11) Patients with anamnesis of hypersensitivity to ingredients of the drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) of metastatic brain tumor, progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, ORR of metastatic brain tumor (evaluated according to RECIST ver. 1.1), PFS of metastatic brain tumor, overall survival (OS), safety | — |
Countries
Japan
Contacts
Public Contact(1) Hiroyuki (2) Kazushige (1) Yamaguchi (2) Wakuda
(1) Nagasaki University Hospital (2) Shizuoka Cancer Center (1) Department of Respiratory Medicine (2) Division of Thoracic Oncology
Outcome results
None listed