Phase II ERCC1 and RRM1-Based Adjuvant Therapy Trial in Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

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