Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer

Inclusion criteria: * Written informed consent * At least 18 years old * Confirmed advanced non-small cell lung carcinoma (NSCLC) * Received one prior chemotherapy for metastatic NSCLC excluding TAXOTERE or HYCAMTIN. In addition, subjects are allowed to have previously received a non-cytotoxic therapy, such as an endothelial growth factor receptor (EGFR) or angiogenesis inhibitor. * Presence of either measurable or non-measurable disease by radiologic study or physical examination. * Full recovery and at least 21 days from prior treatment for NSCLC; 42 days from treatment with mitomycin or nitrosureas and 30 days from prior non-cytotoxic therapy. * At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient). * At least 7 days since prior radiotherapy. * A probable life expectance of at least 3 months. * Adequate bone marrow reserve, CBC/Platelet, kidney and liver function. Exclusion criteria: * Concomitant malignancies or other malignancies within the last five years. * Symptoms of brain metastases requiring treatment with steroids. * Active infection. * Severe medical problems other than the diagnosis of NSCLC that would limit the ability of the subject to follow study guidelines or expose the subject to extreme risk. * Ongoing or planned chemotherapy (other than treatment during this study), immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC. * Use of investigational drug within 30 days or 5 half-lives prior to the first dose of study medication. * Women who are pregnant or lactating. * Subjects of child-bearing potential refusing to practice adequate contraception. * Prior treatment with or history of allergic reaction to either HYCAMTIN or TAXOTERE. * Subjects who cannot receive steroid premedication.