Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)

Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy

The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.

Inclusion Criteria:

• Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to curative surgery or radiotherapy
• At least one prior chemotherapy for palliative therapy
• Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status assessment
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Exclusion Criteria:

• Concurrent administration of any other tumor therapy
• Pregnant or breast feeding
• Serious concomitant disorders
• Inability or unwillingness to take folic acid or vitamin B12 supplementation