Phase II trial of thalidomide, irinotecan and gemcitabine in chemonaive patients with advanced non-small cell lung cancer.

This study aim was to determine the efficacy and safety of the combination of Gemcitabine 1000 mg/m(2) day 1 & 8 and Irinotecan 100 mg/m(2) day 1 & 8 with escalating dose of thalidomide in chemonaive patients with advanced non-small cell lung cancer. Among the 20 patients who met eligibility criteria and received treatment, two patients (10%) experienced partial response and 14 (70%) experienced stable disease. The median time to disease progression was 4 months (95% CI: 2.8-6.6). The 1 year and 2 year survival rates were 36% and 27%, respectively. This combination is active in advanced NSCLC with manageable toxicity profile.