A Phase II/III Double Blind Randomized Trial of BMS-275291 vs. Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer
(NSCLC)

- Local or metastatic failure after surgery and/or radiotherapy allowed

- Phase II only:

- At least one measurable lesion

- At least 20 mm by conventional techniques OR 10 mm by spiral CT scan

- No known CNS metastases unless asymptomatic and at least 4 weeks since prior
corticosteroid therapy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- ALT no greater than 2 times ULN (5 times ULN for liver metastases)

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No significant cardiac disease

- No uncontrolled high blood pressure, unstable angina, congestive heart failure,
second or third degree atrioventricular conduction defects, or ventricular
arrhythmias requiring medication

- No myocardial infarction within the past year

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior allergic reaction to drugs containing Cremophor EL

- No serious active infection or other underlying medical condition that would preclude
study participation

- No peripheral neuropathy

- No condition (e.g., psychological, geographical) that would preclude study
participation

- No prior breast cancer or melanoma

- No other prior malignancy within the past 5 years except carcinoma in situ, basal
cell or squamous cell skin cancer, or other cancer that has been curatively treated
surgically

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy

- No prior biological response modifiers

- No other concurrent biologic therapy or immunotherapy

Chemotherapy:

- No prior antineoplastic chemotherapy, including intrapleural chemotherapy

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy to study lesion (unless evidence of disease progression) or to
30% or greater of marrow bearing bones

- At least 1 week since prior radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 2 weeks since prior major surgery

- No concurrent surgery

Other:

- At least 2 weeks since prior investigational drugs

- No other concurrent cytotoxic anticancer therapy

- No other investigational drugs during and for 30 days after study