Phase I and II clinical studies demonstrated that gefinitib single agent therapy is well tolerated and provides clinically significant antitumor activity in patients with advanced NSCLC who have previously received prior treatment with cytotoxic chemotherapy. Large-scale studies to assess the clinical benefit of gefitinib versus placebo when combined with cisplatin/gemcitabine and carboplatin/paclitaxel as first-line treatment, however, did not prove that the three drug combinations be able to improve survival and compared to "standard"-doubled chemotherapy. Therefore it can be summarized that gefinitib may provide evaluable addition to the therapeutic options available for the treatment of advanced NSCLC and may also have potential for use in early NSCLC.