Following encouraging preclinical evidence suggesting anticancer synergy when docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) and vinorelbine are administered together, a clinical trial was designed to determine the maximum tolerated dose of the combination when given with granulocyte colony-stimulating factor support to 27 patients with advanced non-small cell lung cancer. Doses were escalated in stages to a maximum of 45 mg/m2 vinorelbine and 60 mg/m2 docetaxel, both administered on day 1 of a 2-week cycle. Hematologic toxicity was mild, with febrile neutropenia complicating only four of the 209 cycles delivered. Clinically significant fluid retention and peripheral neuropathy were also uncommon. Major response was seen in 37% of patients. The median survival was 9 months and 1-year survival was approximately 35%. The combination of 45 mg/m2 vinorelbine and 60 mg/m2 docetaxel has now moved into a phase II trial.