Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.

Randomized Phase II Study of Cisplatin + Gemcitabine Administered Either as Short Infusion or at a Fixed Dose Rate in Non-Small Cell Lung Cancer

The purposes of this study are to determine:

How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer.

The safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.

Inclusion Criteria:

• At least 18 years of age
• Histologically or cytologically confirmed diagnosis of NSCLC
• Have provided written informed consent
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Adequate organ function

Exclusion Criteria:

• Prior chemotherapy or biologic therapy (approved or experimental) for NSCLC
• Presence of uncontrolled central nervous system (CNS) metastases
• Inability to comply with protocol or study procedures
• Pregnancy
• Breast feeding