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 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
* Clinically significant laboratory abnormalities, specifically:

  * Total bilirubin ≥ institutional upper limit of normal (ULN)
  * Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN 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 study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of 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 interfere with the assessments and procedures of this protocol
* Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC.
* Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.