Randomized clinical trials of vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) as a single agent and in combination with cisplatin have demonstrated antitumor activity in patients with advanced non-small cell lung cancer (NSCLC). Administered as a single agent on a weekly schedule, the vinorelbine therapeutic profile compares favorably with other regimens currently used in palliative treatment of patients with advanced NSCLC. Vinorelbine is also being considered in other treatment settings as well: adjuvant treatment in stage I and II disease, and regimens with curative intent in stage IIIa and IIIb disease. Future directions for vinorelbine in the treatment of NSCLC are likely to be directed toward combination trials with other agents active in NSCLC. Current phase I-II trials, for example, combine vinorelbine with cisplatin, 5-fluorouracil/leucovorin, mitomycin-C, ifosfamide, carboplatin, and paclitaxel (Taxol; Bristol-Myers Squibb Co, Princeton, NJ). Some phase III trials are planned and some are under way. Vinorelbine has been a focus of interest in multimodality trials. A Canadian trial, for example, combined vinorelbine and cisplatin, followed by accelerated radiation. Results from all these trials can be expected to guide the further development of vinorelbine in adjuvant and neoadjuvant settings in NSCLC. Moreover, trials that are documenting the efficacy of vinorelbine in small cell lung cancer are just beginning.