Randomized phase II trial of daily administrations versus alternate-day administrations of S-1 in patients with advanced non-small cell lung cancer

INTERVENTION: Daily administrations: S‐1 is administered orally twice daily after morning and evening meals at a dose of 40‐60 mg (80‐120 mg/day), depending on the BSA from days 1 to 28, which is followed by 14 days rest. Alternate‐day administrations: S‐1 is administered orally twice daily after morning and evening meals at a dose of 40‐60 mg (80‐120 mg/day), depending on the BSA on Mondays, Wednesdays, Fridays and Sundays CONDITION: Non‐small cell Lung Cancer PRIMARY OUTCOME: Safety; (Incidence of grade3 or higher Adverse Events) SECONDARY OUTCOME: Response Rate; Progression‐free Survival; Overall Survival; Completion rate of 1st course INCLUSION CRITERIA: 1)Histologically or cytologically confirmed NSCLC 2)Unresectable or reccurent NSCLC 3)With or without measurable lesions 4)With at least 1 prior chemotherapy 5)Age of 20 years or older 6)ECOG performance status 2 or less 7)With adequate major organ functions within 14 days before randomization, as defined below: *White blood cell count >= 3,000/mm3 *Neutrophil count >= 1,500/mm3 *Platelet count >= 100,000/mm3 *Hemoglobin >= 9.0 g/dL *AST <= 2.5 x ULN *ALT <= 2.5 x ULN *Total bilirubin <= 1.5 mg/dL *PaO2 >= 60 Torr or SpO2 >= 94% *Estimated CCr >= 50 mL/min. 8)Sufficient oral intake 9)Written informed consent