The aim of the study was to assess the activity and tolerability of the combination of gemcitabine (GEM) and vindesine (VDS) in elderly or poor performance patients with advanced non-small cell lung cancer. Forty four patients (36 males and 8 females with a median age of 70 years and a median Karnofsky performance score of 60) were recruited between January 1998 and June 2001; 9 (20.5%) were stage IIIB patients and 35 (79.5%) were stage IV patients; 20 (45.5%) had squamous carcinoma and 24 (54.5%) non-squamous carcinoma. The patients received GEM 1000 mg/m(2) and VDS 3mg/m(2) (max 5mg) on days 1 and 8 every 3 weeks, and were all evaluable for response and toxicity: 17 (38.6%) were partial responders, 17 (38.6%) experienced stable disease, and 10 (22.3%) progressive disease. Grade 3-4 anemia, neutropenia and thrombocytopenia were observed in, respectively, 6.8, 9.1 and 2.3% of the patients, and grade 2-3 fatigue, paresthesias and skin toxicity in, respectively, 11.4, 20.4 and 2.3%. After a median follow-up of 54 months, 43/44 patients died; median survival was 12 months, and a clinical benefit was observed in 54.5% of cases. GEM plus VDS is an active and well-tolerated schedule.