non small cell lung cancer
Conditions
Interventions
A: Experimental arm Gefitinib (250mg/day) monotherapy until disease progression
B: Reference arm CDDP (80mg/sqm) day1, Docetaxel (60mg/sqm), q3w x 3-6 courses
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.A) Patients with NSCLC who have recurrent disease after surgery with no prior drug therapy for the recurrent disease and who are not candidates for radiotherapy with a curative intent. Those who received postoperative adjuvant chemotherapy other than CDDP+DOC are eligible. OR B) NSCLC patients with stage IIIB or IV disease with no prior treatment who are not candidates for surgical resection or radiotherapy with a curative intent. 2.A case with confirmed EGF-R genomic mutation (deletion in Exon 19 or codon 858 change of Leucin to Arginine in Exon 21) in the histologic or cytologic specimen in which tumor cells definitely exist. 3.A case of which histologic or cytologic (pleural effusion) specimen is reserved if the case needs to be pre-registered because of no confirmation of EGF-R mutation. 4.Patients with evaluable disease (not necessarily to be measurable by RECIST) 5. If the patient underwent pre- or postoperative chemotherapy, there should be the following interval between the chemotherapy and the registration. i) Platinum doublet ->6 months ii) other (UFT and other fluoropyrimmidine, non-platnum) -> 1 month 6. If the patient underwent radiotherapy, there should be the following interval between the radiotherapy and the registration. i)Radiotherapy including pulmonary field ->3 months ii)Radiotherapy other than thoracic radiation ->1 month 7. Age eligible for study: 20 years and above, 75 years and below 8. ECOG PS 0-1 9. Sufficient organ function 10. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Prior drug therapy targeting EGFR (TKI, Abs) 2. History of interstitial pneumonia or pulmonary fibrosis (Patients with radiation pneumonitis limited to radiation field are eligible) 3. History of severe drug allergy 4. History of active infection or other serious disease condition (GI bleeding, poorly controlled cardiac diseases, cirrhosis, ileus, persistant watery diarrhea, etc.) 5. History of symptomatic brain metastases. Brain metastases necessitating drug therapy for brain edema 6. History of poorly controlled pleural effusion 7. History of pericardial effusion or ascites necessitating drainage 8. History of active double cancer 9. History of severe hypersensitivity to polysolvate 80 containing drugs 10. History of pregnancy or lactation 11. Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Response | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed