Inclusion Criteria

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.