Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers

A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" Patients With Advanced Non-Small Cell Lung Cancer

The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.

Inclusion Criteria:

• Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
• Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at least 4 weeks prior to study enrolment.
• Have 'never smoked' (defined as having smoked <100 cigarettes during his/her lifetime)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria:

• Concurrent administration of any other tumor therapy
• Other co-existing malignancies
• Pregnancy or breast feeding
• Serious concomitant disorders
• Inability or unwillingness to take folic acid or vitamin B12 supplementation