An Open-Label, Multicenter, Randomized, Phase III Study Comparing Combination IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Advanced (IIIB/IV) Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

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.