This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.
INCLUSION CRITERIA:
Men or women age 18 years or older
Histologically or cytologically confirmed NSCLC
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
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EXCLUSION CRITERIA:
More than 2 prior chemotherapy regimens
Clinically significant laboratory abnormalities, specifically:
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.
Brownstown, Michigan 48183, United States