OBJECTIVES:

• Compare the overall survival of patients with stage III or IV non-small cell lung cancer treated with oral carboxyamidotriazole (CAI) vs placebo.
• Evaluate the safety and tolerability of oral CAI in these patients.
• Compare the time to disease progression in patients treated with these regimens.
• Compare the quality of life of patients treated with these regimens.
• Determine the response rate of patients with measurable or evaluable disease treated with CAI.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to timing of first-line therapy (prior to registration vs after registration), disease stage (IIIA vs IIIB vs IV), therapy components (chemotherapy and thoracic radiotherapy vs chemotherapy only), ECOG performance status (0 vs 1 vs 2) and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral carboxyamidotriazole daily.
• Arm II: Patients receive oral placebo daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then monthly during study.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 750 patients (375 per treatment arm) will be accrued for this study within 5 years.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage III or IV non-small cell lung cancer (NSCLC)
• Received or plan to receive 1 and only 1 chemotherapy regimen with or without thoracic radiotherapy as first-line therapy for NSCLC
• Disease must be stable or responding after prior or planned chemotherapy for 3-6 months
• No untreated brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months (patients who have received first-line therapy) OR
• At least 6 months (patients who plan to receive first-line therapy)

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10.0 g/dL

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST no greater than 3 times ULN
• Alkaline phosphatase no greater than 3 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No other concurrent immunotherapy

Chemotherapy:

• See Disease Characteristics
• Prior radiosensitizers allowed
• No more than 6 weeks since prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No more than 6 weeks since prior thoracic radiotherapy
• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• No concurrent participation in another phase III lung cancer treatment trial