A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.

Inclusion Criteria

• •1. Female.
• •2. Histologically- or cytologically-confirmed diagnosis of NSCLC.
• •3. ECOG performance score of 2.
• •4. Patients who meet one of the following criteria:
• •* Stage IIIB who are not candidates for combined modality therapy (primary radiation therapy or surgery), or
• •* Stage IV.
• •5. Age greater than or equal to 18 years.
• •6. Adequate bone marrow function
• •7. Adequate renal function
• •8. Adequate hepatic function
• •9. Patients with known brain metastases must have received standard antitumor treatment for their CNS metastases as defined by the site's institutional standards.
• •10. Patients who have had major surgery must be fully recovered from the surgery.
• •11. Ability to comply with the visit schedule and assessments required by the protocol.
• •12. For patients of reproductive potential, commitment to use adequate contraception.
• •13. Signed approved informed consent, with understanding of study procedures.
• •14. Agreement to begin study therapy within 8 calendar days after randomization.
• •7. Clinically significant active infection for which active therapy is underway.
• •8. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent.
• •10. Pregnant women or nursing mothers.
• •11. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.