gefitinib in patients with NSCLC
Conditions
Interventions
gefitinib 250mg/m2 EGFR orally per day
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) NSCLC 2) Chemonaive or prior 1-2 regimens of chemotherapy 3) At least one measurable lesion 4) Availability of tissue sample for immunohistochemical analyses 5) Age > 20 years 6) Adequate main organ functions 7) Performance status (PS) of 0 to 2 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Gefitinib with concurrently other chemotherapy 2) Need of curable radiation therapy to primary lesion. 3) Need of radiation therapy to the biopsy lesion for tissue samples for immunohistochemical analyses 4) Old tissue sample (before 2 regimens from the gefitinib therapy) for immunohistochemical analyses and no way to gain a new tissue sample 5) No estimation of at least 3 months survival 6) Intestinal pneumonia or lung fibrosis 7) History of severe drug allergic reaction 8) Severe infection and complication (cardio insufficiency or hemorrhage etc.) 9) Severe diarrhea 10) Bowel obstruction 11) Symptomatic brain metastasis 12) History of other malignancy 13) Pregnant women or women willing child-bearing 14) No regulatory condition because of psychological disease 15) Inadequate condition diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and efficacy of gefitinib | — |
Secondary
| Measure | Time frame |
|---|---|
| Relationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and disease control rate or safety of gefitinib | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed