The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.

Inclusion Criteria:

• 18 years of age or older
• Histologically confirmed non-small cell lung cancer (NSCLC)
• Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)
• Measurable disease by RECIST
• ECOG status of 0-1
• Adequate liver and renal function
• Adequate bone marrow reserves

Exclusion Criteria:

• Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC
• Up to one prior adjuvant or neoadjuvant chemotherapy is allowed
• History of bone marrow transplantation or stem cell support
• Pregnant or lactating women