Phase 3, Randomized, Double-Blind, Placebo-controlled Study of CBT-1 and Paclitaxel/Carboplatin in Patients With Inoperable Non-Small Cell Lung Cancer

Inclusion Criteria:

- histological confirmed diagnosis of NSCLC

- advanced inoperable NSCLC

- have adequate renal function, serum creatinine <2.0 mg/dL or 24 hour creatinine
clearance > 50mL/minute

- have adequate liver function defined as SGOT <4 times the upper limit of normal (ULN)
and bilirubin <2.0 mg/dL

- have calcium <11.0 mg/dL and albumin >2.0g/dL

- have adequate bone marrow reserve defined as granulocyte count >1,500/mm3, hemoglobin
>10.0 g/dL and platelets >100,000/mm3

- if female and of child-bearing potential, agree to use one of the following methods
of birth control: oral contraceptives, barrier with spermicide, intrauterine
progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone
acetate contraceptive injection, complete abstinence from sexual intercourse

Exclusion Criteria:

- have previously received taxanes, platinums, vinca alkaloids, anthracyclines,
epipodophyllotoxins or CBT-1

- have known or suspected hypersensitivity to platinum containing compounds, taxanes,
polyoxyethylated castor oil, or mannitol

- have significant central nervous system disease, including history of seizures within
last 3 months or psychiatric history which would impair the ability to give informed
consent or prevent compliance with protocol requirements

- be eligible for curative surgery or radiotherapy.

- must not have a diagnosis and/or treatment in the past 5 years of any malignancy
other than NSCLC or basal cell carcinoma of the skin

- be pregnant or nursing

- have a history of significant coronary artery disease, cardiac arrhythmias requiring
treatment, history of other cardiac disease or other cardiac anomalies determined by
ECG which in the judgment of the investigator would compromise the patient's ability
to tolerate the therapy

- have ongoing serious infections that require parenteral antibiotics

- have clinically significant bleeding disorders

- have solid organ allograft

- have significant intercurrent disease

- have bleeding peptic ulcer disease

- have participated in any experimental study within 2 months preceding enrollment

- be using a medication that could interact adversely with CBT-1, paclitaxel, or
carboplatin. Medications include:aminoglycoside antibiotics, Prilosec, Losec, Zantac