- Confirmed diagnosis of non small cell lung cancer with a primary histology of
predominantly squamous cell, large cell or adenosquamous carcinoma.
- Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or
recurrent disease.
- No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant
chemotherapy must have completed for greater than or equal to 12 months prior to
randomization.
- Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to
randomization and all acute toxicities have resolved.
- ECOG performance status (PS) 0 or 1.
- Patients with symptomatic central nervous system (CNS) metastases are not permitted.
- Patients requiring chronic steroid use or patients with uncontrolled diabetes are not
permitted.
- Patients with other active cancer types are not permitted.