Randomized comparative study of cisplatin, docetaxel, and irinotecan versus cisplatin and docetaxel in patients with stage IIIB or stage IV non-small cell lung cancer (OLCSG 0403)

INTERVENTION: Intervention arm: Cisplatin (60mg/m2, day1), Docetaxel (60mg/m2, day 1), Irinotecan (60mg/m2, day 2) combination chemotherapy Control arm: Cisplatin (80mg/m2, day1), Docetaxel (60mg/m2, day 1) combination chemotherapy CONDITION: Stage IIIB or Stage IV Non‐Small Cell Lung Cancer PRIMARY OUTCOME: Overall survival; Quality of life SECONDARY OUTCOME: Best overall response; Duration of overall response; Time to progression; Adverse event INCLUSION CRITERIA: 1. Histologically and/or cytologically proven NSCLC 2. No prior treatment 3. Age<=70 4. stage IIIB, or IV 5. ECOG performance status: 0‐1 6. Measurable or evaluable disease 7. Adequate bone marrow function: WBC>=4,000/cmm and PLT>=100,000/cmm 8. Adequate liver function: T‐Bil<=1.5 mg/dl, GOT, GPT<=2.5 x normal value 9. Adequate renal function: Creatinine<1.5 mg/dl and Ccr>=60 ml/min 10. Adequate pulmonary function: PaO2>=60 Torr (room air, at rest) 11. Written informed consent