Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

INCLUSION CRITERIA:

• Men or women age 18 years or older

• 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 pleuraleffusion

• Failed or relapsed after receiving a platinum-containing chemotherapy regimen asfirst-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

• Clinically significant laboratory abnormalities, specifically:

• Total bilirubin ≥ institutional upper limit of normal (ULN)

• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 xULN concomitant with alkaline phosphatase >2.5 x ULN

• Serum creatinine ≥2.0mg/dL

• Absolute neutrophil count <1500/μL or platelets <100,000/μL

• Untreated or symptomatic brain metastases

• Any malignancy within the 5 years immediately prior to the first dose of studymedication with the exception of basal cell or non-metastatic squamous cell carcinomaof the skin, and carcinoma in-situ of the cervix

• A history of severe hypersensitivity to drugs formulated with polysorbate 80

• Any comorbidity or condition which, in the opinion of the investigator, may interferewith the assessments and procedures of this protocol

• Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, orother investigational medication for NSCLC.

• Pregnancy or lactation. Women of childbearing potential and non-vasectomized men mustagree to use a barrier method of contraception.