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Background. To evaluate the safety and efficacy of second- line chemotherapy with docetaxel and cisplatin for non- small cell lung cancer (NSCIL), we performed a phase II study. Methods. The subjects were 25 patients with NSCIJC, 75 years or younger, without organ dysfunction (performance status [PS], 0 to 2) in whom treatment with cisplatin and irinotecan had been ineffective or had been followed by recurrence or relapse. Four weeks or more after the end of the previous therapy, 60 mg/m² of cisplatin and 60 mg/m² of docetaxel were administered at intervals of 3 weeks. Results. Observed toxicities of grade 3 or 4 included anemia (24% of patients), leukocytopenia (48%), neutropenia (76%), thrombocytopenia (4%), hepatic dysfunction (8%), and electrolyte abnormalities (4%). However, no severe non hem atologic adverse reactions occurred. The overall response rate was 32% (95% confidence interval, 13.7- 50.3). The median time to disease progression was 98 days, and the median survival time was 257 days. Conclusion. Our results suggest that cisplatin and docetaxel can be used as second-line chemotherapy against NSCIL. But further, comparative, study of this combination should be performed in patients with good PS and organ function who have responded to prior platinum-based chemotherapy. [ABSTRACT FROM AUTHOR]