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.