Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Inclusion Criteria:

- Male and females ≥ 18 years of age

- ECOG performance status ≤ 1

- Pathologically or histologically confirmed advanced non-small cell lung cancer
(unresectable Stage IIIb or IV) that has progressed after treatment with at least one
chemotherapy regimen; measurable disease is not required for enrollment into this
trial

- All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have
resolved to Grade ≤ 2

- Signed informed consent

Exclusion Criteria:

- Administration of certain chemotherapy, biological, immunotherapy, radiation therapy,
surgery or investigational agent within specified time frames

- Significant cardiac history

- Prior treatment with tumor vascular disruptive agents

- Seizure disorder

- Brain metastases

- Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy

- Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or
C

- Patients with a prior hypersensitivity reaction to product components

- Pregnant or breast-feeding women.

- Concurrent, active second malignancy for which the patient is receiving therapy,
excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix

- Unwilling or unable to comply with procedures required in this protocol