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

Inclusion Criteria:

* Men or women age ≥18 years
* Histologically or cytologically confirmed NSCLC (Recurrent, locally advanced or metastatic, inoperable NSCLC \[Stage IIIB/IV\]. Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion.)
* Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
* Measurable disease on computerized tomography (CT) scan
* ECOG Performance Status of 0 or 1
* Expected survival ≥12 weeks
* Provide written informed consent

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.