Non-small cell lung cancer
Conditions
Interventions
Sponsors
Dokkyo Medical University
Tochigi-kitakan Thoracic Oncology Research Organization (TOTORO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically and/or cytologically proven NSCLC 2) Unresectable clinical stage IIIB/IV 3) Patients who have sensitive EGFR mutation (exon19 deletion, exon21 L858R) 4) Previous treated with platinum combination chemotherapy and EGFR-TKI (gefitinib or erlotinib), or the platinum combination chemotherapy is unacceptable 5) Measurable or evaluable disease for RECIST 6) Age: over 20 7) PS (ECOG): 0-2 8) Adequate organ functions judged by laboratory tests 9) Life expectancy: over 3 months 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patient with serious disease condition (interstitial pneumonia, lung fibrosis, pneumoconiosis, drug-induced pneumonia, radiation pneumonitis) 2) Patient with much ascetic fluid, pleural effusion, cardiac effusion. 3) Patient with active infection 4) Pregnancy 5) Symptomatic brain metastases 6) Patient with active double cancer 7) Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities. 8) Considered to be interfere to the agreement or understanding the protocol by attending doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR), Progression free survival (PFS), Overall survival (OS), Safety and Biomarker research of afatinib | — |
Countries
Japan
Contacts
Public ContactRyo Arai
Dokkyo Medical University Department of Pulmonary Medicine and Clinical Immunology
Outcome results
None listed