Neoadjuvant IRESSA As Single Agent PreopTherapy for NSCLC With Molecular Correlates

DISEASE CHARACTERISTICS:

* Histologically confirmed resectable non-small cell lung cancer (NSCLC), meeting 1 of the following clinical staging criteria:

  * Stage IA or IB (T1-2, N0)
  * Stage II (T1-2, N1 with negative mediastinoscopy or T3, N0)
  * Stage IIIA (T3, N1 with negative mediastinoscopy)

    * Level 10 hilar nodes may be positive provided mediastinoscopy is negative
* The following are not allowed (as evidenced by clinical staging criteria \[CT scan, positron-emission tomography (PET) scan, or mediastinoscopy):

  * Positive N2 lymph nodes (ipsilateral/subcarinal mediastinal lymph nodes)
  * Positive N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scalene lymph nodes)
  * T4 primary tumor (malignant pleural effusion or mediastinal invasion)
  * Symptomatic tumors (T3, N0-1) involving the superior sulcus (i.e., Pancoast tumors)
* Measurable disease by contrast-enhanced CT scan
* No metastatic disease (except peribronchial or hilar lymph node involvement \[N1\]) by fludeoxyglucose F 18 PET scan
* No malignant pleural effusion by preoperative evaluation

  * Pleural effusions visible only on CT scan that are not large enough for safe thoracentesis are allowed
  * No exudative effusions (even if cytologically negative), as evidenced by any of the following:

    * Ratio of pleural fluid protein to serum protein \> 0.5
    * Ratio of pleural fluid lactic dehydrogenase (LDH) to serum LDH ≥ 0.6
    * Pleural fluid LDH \> 200 IU/L
* No superior vena cava syndrome
* No spinal cord compression

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Eastern Cooperative Oncology Group (ECOG) 0-1

Life expectancy

* Not specified

Hematopoietic

* WBC ≥ 4,000/mm\^3
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT ≤ 2 times ULN
* Alkaline phosphatase ≤ 2 times ULN

Renal

* Creatinine \< 1.5 times ULN

Cardiovascular

* No uncontrolled ventricular arrhythmia
* No myocardial infarction within the past 3 months

Pulmonary

* Pre-resection FEV\_1 \> 2.0 L OR
* Predicted post-resection FEV\_1 \> 1.0 L
* No clinically active interstitial lung disease

  * Chronic stable asymptomatic radiographic changes allowed
* No post-obstructive pneumonia

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to provide tumor biopsy pre- and post-gefitinib administration AND undergo PET scan
* No known severe hypersensitivity to study drug or any of its excipients
* No uncontrolled major seizure disorder
* No unstable or uncontrolled diabetes mellitus
* No serious infection requiring IV antibiotics
* No grade 3 neuropathy
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No other unstable or serious medical condition that would preclude study treatment or surgery
* No psychiatric disorder that would preclude giving informed consent
* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow up
* No other significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior or concurrent systemic chemotherapy for NSCLC

Endocrine therapy

* Not specified

Radiotherapy

* No prior or concurrent radiotherapy for NSCLC

Surgery

* Recovered from prior oncologic or other major surgery
* At least 5 years since prior resection of lung disease
* No prior surgery for NSCLC
* No concurrent ophthalmic surgery

Other

* More than 30 days since prior non-approved or investigational drugs
* No other concurrent therapy for NSCLC
* No other concurrent investigational therapy
* No concurrent use of any of the following medications:

  * Phenytoin
  * Carbamazepine
  * Barbiturates (e.g., phenobarbital)
  * Rifampin
  * Hypericum perforatum (St. John's wort)