This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Inclusion Criteria:

• Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
• No prior chemotherapy for lung cancer.
• Patients must have at least one uni-dimensionally measurable lesion.
• Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.

Exclusion Criteria:

• Treatment with any drug within the last 30 days that has not received regulatory approval.
• Serious cardiac condition.
• Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
• Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
• Presence of fluid retention that cannot be controlled by drainage.

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.