The combination of docetaxel and gemcitabine is an active 1(st) line chemotherapy against NSCLC. This phase II study aimed to assess the efficacy and safety of this combination in patients with stage IIIB/IV NSCLC. Pts were treated with gemcitabine 800 mg/m(2) dl, d8 and docetaxel 85 mg/m(2) d8, q3w. 34 pts were enrolled. PR was observed in 8 pts (25.8%; 95% CI, 10.4%-41.2%), SD in 16 (51.6%) and PD in 7 (22.6%). The median duration of response and the TTP were 8.9 and 5.3 months, while the median survival time was 10.9 months. The 1 and 2-year survival rates were 45% and 18%. Most toxicities were mild and nonhematologic. Neutropenia G3/4 occurred in 6 (17,6%) pts. In conclusion combination therapy with docetaxel and gemcitabine is an effective and well-tolerated (1st) line treatment option in pts with stage IIIB/IV NSCLC.