Laboratory Test in Predicting Response to Erlotinib in Patients With Relapsed Metastatic or Unresectable Non-Small Cell Lung Cancer That Did Not Respond to Previous Treatment

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed metastatic or unresectable non-small cell lung cancer
* Relapsed disease

  * Failed ≥ 1 prior chemotherapy regimen
* Measurable disease
* Tumor must be accessible to fine-needle aspiration
* No uncontrolled brain metastases

  * Patients with brain metastases must have stable neurologic status after local therapy (surgery or radiotherapy) for ≥ 4 weeks and no neurologic dysfunction that would preclude evaluation of neurologic and other adverse events

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 12 weeks
* WBC \> 3,000/mm³
* Absolute neutrophil count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Bilirubin normal
* PT and activated PTT normal
* Creatinine normal OR creatinine clearance \> 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled intercurrent illness, including, but not limited to, any of the following:

  * Ongoing or active infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Cardiac arrhythmia
  * Psychiatric illness or social situation that would preclude study compliance
* No significant ophthalmologic abnormalities\*, including any of the following:

  * Severe dry eye syndrome
  * Keratoconjunctivitis sicca
  * Sjögren's syndrome
  * Severe exposure keratopathy
  * Disorders that might increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
* No serious, nonhealing wound, ulcer, or bone fracture
* No significant traumatic injury within the past 14 days NOTE: \*Patients with mild forms of any of the above ophthalmologic abnormalities, an asymptomatic history, or a normal ophthalmologic examination allowed at the discretion of the investigator. Patients with treatable conditions (e.g., infectious keratitis/conjunctivitis or allergic conjunctivitis) allowed after treatment or resolution of the condition.

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior small molecule inhibitors of epidermal growth factor receptor, including erlotinib hydrochloride or gefitinib
* At least 4 weeks since prior anticancer therapy, including chemotherapy, radiotherapy, biologic therapy, or other investigational therapy (6 weeks for nitrosoureas or mitomycin C)
* More than 14 days since prior major surgery or open biopsy and recovered
* At least 7 days since prior and no concurrent inhibitors of CYP3A4, including any of the following:

  * Itraconazole
  * Herbal extracts and tinctures, including any of the following:

    * Hydrastis canadensis (goldenseal)
    * Uncaria tomentosa (cat's claw)
    * Echinacea angustifolia roots
    * Trifolium pratense (wild cherry)
    * Chamomile
    * Licorice root
    * Dillapiol
    * Naringenin
* No concurrent inducers of CYP3A4, including any of the following:

  * Phenytoin
  * Carbamazepine
  * Rifampin
  * Barbiturates
  * Hypericum perforatum (St. John's wort)
* No concurrent chemotherapy
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent radiotherapy, including palliative radiotherapy
* No concurrent therapeutic anticoagulation
* No other concurrent anticancer agents or therapies