This study was designed to compare the outcome of stage IIIB /IV non- small cell lung cancer patients who were treated with chemotherapy but did not participate in clinical trials of first-line chemotherapy with patients that had been treated with three clinical trials during this period. From October 1997 through October 1999, 132 patients (stage IIIB, 31 patients; stage IV, 101 patients) who received at least one dose of chemotherapy but did not participate in first- line chemotherapy trials were included. Response was evaluated in 132 patients. Six (4.5%) achieved a complete response and 32 (24.3%) achieved a partial response, resulting in an overall response rate of 28.8% (95% CI, 21.0–36.6). The median overall survival for all 132 patients was 11 months (95% CI, 9.5–12.5), and the median progression-free survival was 4.2 months (95% CI, 3.4–5.0) . The median overall and progression-free survival for patients (N = 129) who participated in one of three clinical trials during the study period was 13.5 months (95% CI, 11. 2–15.8) and 5.6 months (95% CI, 4.9–6.0), respectively. There was no significant difference in overall and progression-free survival between patients who did or did not participate in clinical trials (overall survival: P = 0. 36; progression-free survival : P = 0.57). Our data suggest that the survival of patients who received chemotherapy but did not participate in clinical trials was similar to patients participated in clinical trials. ; 附設醫院腫瘤醫學部 ; 醫學院附設醫院 ; 期刊論文