Paclitaxel (Taxol ® ) as single agent has shown promising activity in advanced non-small-cell lung cancer (NSCLC). In our phase II trial, we have determined the efficacy of paclitaxel combined with cisplatin. Inclusion criteria were good performance status, adequate renal as well as bone marrow function and no prior chemotherapy. Patients with signs of severe cardiac or hepatic dysfunction, pregnancy, clinical manifest neuropathy or manifest cerebral metastasis were excluded. Twenty patients with histologically proven NSCLC stage IIIB or IV were treated with paclitaxel (175mg/m 2 ) as 3-hour infusion after standard premedication on day 1 and cisplatin (50mg/m 2 daily) on days 1 and 2 with antiemetic therapy and sufficient pre- and posthydration. Treatment cycles were repeated every 3 weeks. Progressive disease resulted in discontinuation of treatment. All 20 patients were evaluable for response and toxic effects. Partial responses were seen in 7 patients (35%), no change in 9 patients (45%) and progressive disease in 4 patients (20%). Major side effects included leukopenia (WHO Grade 4 in 1 patient), anemia, alopecia and dose-limiting neurotoxicity (WHO Grade 3 in 1 patient). No severe hypersensitivity reaction has been observed. Thus paclitaxel/cisplatin has shown good antitumor activity in patients with advanced NSCLC and should be further evaluated in this disease.