An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-Naive Patients With Extensive Disease-Small Cell Lung Cancer.

Inclusion Criteria:

- Written informed consent (patient's written understanding of and agreement to
participate in this study).

- Patients with confirmed extensive small cell lung cancer (SCLC).

- No prior chemotherapy within 5 years of the diagnosis of SCLC.

- Presence of either measurable or non-measurable SCLC by X-ray or physical
examination.

- At least 3 weeks since last major surgery (a lesser period is acceptable if decided
to be in the best interest of the patient).

- At least 24 hours since prior radiotherapy. Patients who have received radiotherapy
must have recovered from any reversible side effects, such as nausea and vomiting.

- Laboratory criteria: Patients must have adequate bone marrow reserve and adequate
kidney and liver function.

Exclusion Criteria:

- Symptoms of spreading of the disease to the brain that requires treatment with drugs
called steroids.

- Any active infection.

- Severe medical problems other than the diagnosis of SCLC, that would limit the
ability of the patient to follow study guidelines or that would expose the patient to
extreme risk.

- Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational
therapy for the treatment of SCLC.

- Use of an investigational drug within 30 days before the first dose of study
medication.

- Women who are pregnant or lactating.

- Patients of child-bearing potential who refuse to practice an adequate form of birth
control.

- Patients with clinical evidence of any stomach or intestinal (GI) condition.

- Patients requiring treatment with the drug cyclosporin A.