A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared With Taxol and Carboplatin as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

- Histologically or cytologically confirmed stage IIIB or IV NSCLC

- Male or non-pregnant and non-lactating female, and equal or greater than age 18

- If a female patient is of child-bearing potential, as evidence by regular menstrual
periods, she must have a negative serum pregnancy test (BhCG) documented within 72
hours of the first administration of study drug

- If sexually active, the patient must agree to utilize contraception considered
adequate and appropriate by the investigator

- No other current active malignancy

- Radiographically-documented measurable disease (defined by the presence of at least 1
radiographically documented measurable lesion)

- Patients must have received no prior chemotherapy for the treatment of metastatic
disease. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was
completed 12 months prior to starting the study

- Patient has the following blood counts at baseline:

- ANC greater than or equal to 1.5x10^9/L

- Platelets greater than or equal to 100x10^9/L

- Hgb greater than or equal to 9g/dL

- Patient has the following blood chemistry levels at baseline:

- AST (SGOT), ALT (SGPT) less than or equal to 2.5x upper limit of normal range (ULN)or
less than or equal to 5.0x ULN if liver metastases;

- total bilirubin less than or equal to ULN

- creatinine less than or equal to 1.5mg/dL

- Expected survival of greater than 12 weeks

- ECOG performance status 0 or 1

- Patient or his/her legally authorized representative or guardian has been informed
about the nature of the study, and has agreed to participate in the study, and signed
the Informed Consent form prior to participation in any study-related activities

Exclusion Criteria:

- Evidence of active brain metastases, including leptomeningeal involvement. Prior
evidence of brain metastasis permitted only if stable 2 months after completion of
treatment

- The only evidence of disease is non-measurable

- Patient has pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE).

- Patient received radiotherapy in last 4 weeks, except if to a non-target lesion only.
Prior radiation to a target lesion is permitted only if there has been clear
progression of the lesion since radiation was completed

- Patient has a clinically significant concurrent illness

- Patient has received treatment with any investigational drug within the previous 4
weeks

- Patient has a history of allergy or hypersensitivity to any of the study drugs

- Patient has serious medical risk factors involving any of the major organ systems
such that the investigator considers it unsafe for the patient to receive an
experimental research drug

- Patient is enrolled in any other clinical protocol or investigational trial that
involves administration of experimental therapy and/or therapeutic devices