OBJECTIVE: To evaluate trastuzumab for the treatment of advanced non-small-cell lung cancer (NSCLC). DATA SOURCES: Clinical literature was accessed through MEDLINE (1966-January 2003), EMBASE (1974-January 2003), International Pharmaceutical Abstracts (1970-January 2003), Proceedings of the American Society of Clinical Oncology (1995-January 2003), and Genentech. Key search terms included trastuzumab, lung cancer, Herceptin, and NSCLC. DATA SYNTHESIS: Research has revealed that NSCLC specimens may express the protein HER-2/neu. The monoclonal antibody against HER-2/neu, trastuzumab, could prove valuable for patients. An evaluation of the studies exploring trastuzumab for management of NSCLC was conducted. Phase 11 clinical trials reveal variable response rates from no improvement to a partial response rate of 42%. Due to a lack of clinical trials and deficiencies in the literature, the ultimate benefit of this agent remains to be proven. CONCLUSIONS: Clinical data from ongoing trials indicate potential synergy when trastuzumab is added to standard chemotherapy. The ultimate benefit in NSCLC remains to be proven.