The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer

Inclusion Criteria: * Written informed consent * Age \> 18 * Histological diagnosis of non small-cell lung cancer (NSCLC) * Stage IIIb or Stage IV disease (in IIIb, previous treatment with chemotherapy + radiotherapy, or metastatic supraclavicular lymph nodes or pleural effusion) * Disease in progression * Previous chemotherapy with platinum-derivative (and with \> 21 days from last administration) Exclusion Criteria: * ECOG performance status \> 2 * Age \> 75 years * History of malignant neoplasm within the previous 5 years (except for baso- or spino-cellular skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated) * Previous treatment with docetaxel * Presence of symptomatic cerebral metastasis * Neutrophils \< 2.0 x 109/l, platelets \< 100,000/l, hemoglobin \> 10g/dl * Bilirubin \< 1.5 x the upper normal limit * SGOT , SGPT, or bilirubin \> 1.25 x the upper normal limits except in the presence of hepatic metastasis * Creatinine \>1.25 x the upper normal limit * Any concomitant pathology that would, in the Investigator's opinion, contraindicate the use of the drugs in the protocol * Inability to comply with follow up * Pregnant or nursing females