Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

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

  * Stage IIIB (with pleural effusion) or stage IV disease
  * Recurrent disease after prior surgery
* Measurable or evaluable disease is desirable but not required
* No untreated symptomatic brain metastases

  * Patients who are neurologically unstable despite radiotherapy for the brain metastases are not eligible
  * No requirement for steroids to control neurological symptoms

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* ANC ≥ 1,500/mm³
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 2.0 mg/dL
* Total bilirubin ≤ 1.5 mg/dL
* Normal hemostasis by history
* PT/PTT within 0.5 seconds of normal range
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to undergo biopsy procedures
* No known severe hypersensitivity to erlotinib hydrochloride or any of the excipients of this product
* No other concurrent malignancies or malignancies diagnosed within the past 5 years, except basal cell carcinoma or cervical cancer in situ
* No significant cardiac disease, including any of the following:

  * NYHA class III or IV heart disease
  * Uncontrolled dysrhythmia
  * Myocardial infarction within the past 6 months
* No evidence of clinically active interstitial lung disease

  * Chronic stable radiographic changes that are asymptomatic allowed
* No evidence of any other severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
* No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
* No uncontrolled hypertension

  * Blood pressure must be ≤ 150/90 mmHg on a stable antihypertensive regimen

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 6 months since prior adjuvant chemotherapy
* No unresolved chronic toxicity \> CTC grade 2 from prior anticancer therapy (except alopecia)
* More than 30 days since prior non-approved or investigational drugs
* No prior chemotherapy for advanced NSCLC
* No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or St. John's wort
* No concurrent administration of other drugs known to inhibit EGFR
* No other concurrent anti-neoplastic or anti-tumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
* No other concurrent investigational agents
* Concurrent cardioprotective doses of aspirin, as recommended by the physician, for cardiovascular disease allowed