non-small cell lung cancer
Conditions
Interventions
gefitinib 250mg/m2 /day orally
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Inoperable stage III or stage IV NSCLC 2) Chemonaive or prior 1-2 regimens of chemotherapy 3) Availability of tissue sample for mutation analyses 4) At least one measurable lesion 5) Age 20 years or older 6) Performance status (PS) of 0 to 2 7) Adequate main organ functions 8) No prior treatment of gefitinib or erlotinib 9) Written informed consent
Exclusion criteria
Exclusion criteria: Intestinal pneumonia or lung fibrosis 2) History of severe drug allergic reaction 3) Severe infection and complication (cardio insufficiency or hemorrhage etc.) 4) Severe diarrhea 5) Bowel obstruction,ileus 6) Symptomatic brain metastasis 7) History of other malignancy 8) Pregnant women or women willing child-bearing 9) No regulatory condition because of psychological disease 10) Inadequate condition diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Primary Endpoint) Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary Endpoint) Overall survival, One year survival, Time to progression, disease control rate, safety | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed