S0720: Adjuvant Therapy Based on Gene Expression in Stage IA and IB Non-Small Cell Lung Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed non-small cell lung cancer
• * Stage IA (longest tumor diameter 2-3 cm) or stage IB disease
• Must have undergone preoperative CT scan of the chest (including the entire liver and adrenals) with IV contrast AND a whole body PET scan or a combined PET/CT scan with no evidence of N1, N2, N3, or M1 disease within 42 days prior to surgery
• A whole body PET scan or a combined PET/CT must be performed within 84 days
• * Any finding on PET scan that clinically suggests N1, N2, N3, or M1 disease must have been cleared by further evaluation, including, but not limited to, any of the following:
• * Ultrasonography, X-ray radiology, magnetic resonance imaging, or nuclear medicine imaging
• Completely resected (R0) disease by lobectomy, bilobectomy, or pneumonectomy performed by open thoracotomy or video-assisted thoracoscopic surgery within the past 35 days
• * Completely excised primary lesion with negative gross and microscopic margins
• * At least two mediastinal lymph node stations sampled
• Must have tumor tissue available from the surgical resection specimen AND agree to have treatment assignment determined by a gene expression analysis performed on that tissue
• PATIENT CHARACTERISTICS:
• Zubrod performance status 0-1
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 mg/dL
• Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 1.5 times ULN
• Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other prior malignancy except for the following:
• * Adequately treated basal cell or squamous cell skin cancer
• * In situ cervical cancer
• * Adequately treated stage I-II cancer from which the patient is currently in complete remission
• * Any other cancer from which the patient has been disease-free for 5 years
• Willing to provide prior smoking history
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior systemic chemotherapy or biologic therapy for lung cancer
• No prior thoracic radiation therapy (RT) (including RT to the chest wall)
• No other concurrent investigational agents, chemotherapeutic agents, RT, or hormonal therapy
• * Steroids administered for antiemesis, adrenal failure, or septic shock OR hormones administered for non-disease-related conditions (e.g., insulin for diabetes) allowed