Lung Cancer
Conditions
Interventions
Sponsors
Kagoshima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with NSCLC with a histological diagnosis or cytodiagnosis 2) Patients with EGFR gene mutation 3) Patients with unresectable advanced case 4) Patients that 14 days pass from the last dosage of systemic chemotherapy 5) Patients with more than 20 years old 6) Patients with ECOG PS 0,1,2 7) Patients harboring a more than one measurable lesion 8) Patients that expected survival time is more than 2 months 9) Patients with adequate organ function Neutrophil >= 1500/mm3 Platelet >= 100,000/mm3 Hemoglobin >= 8.0g/dl AST,ALT <=2.5 x ULN Total bilirubin <= 2mg/dl 10) Patients providing written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with interstitial pneumonitis or pulmonary fibrosis 2) Patients with serious infection 3) Patients with unsteady angina or cardiac infarction 4) Patients with severe complication 5) Patients with active double cancer 6) Patients requiring medication influenced P glycoprotein 7) Patients with history of dosage afatinib 8) Patients with contraindication against afatinib 9) Patients with history of serious hypersensitivity or allergy 10) Pregnant, pregnancy suspect, nursing women, patients who plan to have a baby 11) Patients with complication with mental disease or a mind symptom, and are judged to have difficulty in participation in the study 12) Any other patients who are regarded as unsuitable for this study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of T790M mutation and concordance rate between blood and tumor tissue at PD | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) PFS 2) ORR 3) TTF 4) OS 5) Safety 6) The correlation between blood concentration of afatinib and safety | — |
Countries
Japan
Contacts
Public ContactKeiko Mizuno
Kagoshima University Hospital Department of Pulmonary medicine
Outcome results
None listed