Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

Exclusion Criteria

• •More than 2 prior chemotherapy regimens
• •Progression of disease on prior pemetrexed treatment
• •Brain metastases (exception: patients who had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month)
• •Serum creatinine ≥2.0mg/dL or creatinine clearance \<45mL/min
• •Absolute neutrophil count \<1500/μL or platelets \<100,000/μL
• •Any malignancy within 5 years immediately prior to the first dose of study medication (exception: basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix)
• •Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
• •Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment.
• •Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception during treatment.