RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This clinical trial is studying how well erlotinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

OBJECTIVES:

Primary

• Determine downstream markers of epidermal growth factor receptor-linked signaling pathways that are predictive of response to erlotinib in patients with stage IIIB or IV or recurrent non-small cell lung cancer.

Secondary

• Determine antitumor objective response rate in patients treated with this drug.
• Determine disease control rate (complete response, partial response, or stable disease) in patients treated with this drug.
• Determine time to progression and overall survival of patients treated with this drug.
• Determine whether a grade 2 rash is a predictor of response to this drug and of survival of these patients.
• Determine the safety profile of this drug in these patients.
• Correlate smoking status, as measured by the Smoking Status Survey, with disease outcome and overall survival in patients treated with this drug.

OUTLINE: This is a pilot, multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients complete the Smoking Status Survey, a questionnaire regarding smoking habits, at baseline, and then every 3 months during study treatment.

After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 129 patients will be accrued for this study within 6 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer (NSCLC)*

  • Stage IIIB with malignant pleural effusion or IV or recurrent disease NOTE: *Must have diagnostic specimen available on paraffin-embedded block

• Measurable disease

  • Previously irradiated areas are considered measurable if there is documented disease progression
• Stable, treated brain metastases allowed provided patients are asymptomatic and not taking corticosteroids

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3

Hepatic

• AST and ALT < 2 times upper limit of normal
• Bilirubin < 1.5 mg/dL

Renal

• Creatinine < 1.5 mg/dL OR
• Creatinine clearance > 50 mL/min

Cardiovascular

• No unstable angina pectoris
• No symptomatic congestive heart failure
• No symptomatic cardiac arrhythmia

Gastrointestinal

• No requirement for IV alimentation
• No active peptic ulcer disease
• No gastrointestinal tract disease resulting in an inability to take oral medication

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No bone fracture
• No serious non-healing wound
• No active or ongoing infection
• No psychiatric illness that would preclude study compliance
• No comorbidity that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 2 weeks since prior immunotherapy and recovered
• No concurrent routine myeloid growth factors

Chemotherapy

• No prior chemotherapy for metastatic disease

  • Prior adjuvant chemotherapy for stage IB-IIIA disease OR chemoradiotherapy for stage IIIA or IIIB disease allowed provided both of the following criteria are met:

    • Prior treatment completed ≥ 6 months ago
    • Patient now presents with advanced disease

Endocrine therapy

• See Disease Characteristics
• More than 2 weeks since prior hormonal therapy and recovered

Radiotherapy

• See Disease Characteristics
• See Chemotherapy
• More than 2 weeks since prior radiotherapy and recovered

Surgery

• More than 21 days since prior major surgical procedure
• No prior surgical procedure affecting absorption

Other

• No prior epidermal growth factor receptor inhibitors
• No prior targeted therapy for metastatic disease
• At least 1 week since prior CYP3A4 inducers or inhibitors
• Concurrent warfarin allowed
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent grapefruit juice
• No concurrent enrollment in any other clinical trial