Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Biopsy-proven stage IIIA nonsquamous non-small cell lung cancer

  • pN2 disease proven by mediastinoscopy

• Meets any of the following criteria:

  • Never smoked
  • EGFR mutations (in exon 18, 19, or 21)*
  • FISH positive for EGFR* NOTE: *Irrespective of smoking history
• Presence of at least 1 unidimensionally measurable lesion on thoracic CT scan, according to RECIST
• Feasible to undergo pneumonectomy or lobectomy

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-1
• FEV_1 ≥ 2.0 L in preoperative pulmonary function test
• Hemoglobin ≥ 9.0 g/dL
• WBC 4,000-12,000/μL
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/mm³
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 3.0 times ULN
• AST and ALT ≤ 3.0 times ULN
• Creatinine ≤ 1.5 times ULN
• Negative pregnancy test

Exclusion criteria:

• Severe complications or infections
• Pregnant or breast-feeding women
• Clinically significant heart disease
• Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
• Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy, chemotherapy, hormone therapy, or target therapy
• No other concurrent systemic anticancer therapies, including experimental drugs, chemotherapy, immunotherapy, or radiotherapy