• Survival [ Designated as safety issue: No ]
• Functional and symptom status [ Designated as safety issue: No ]
• Correlation of epidermal growth factor receptor (EGFR) expression levels and/or EGFR polymorphisms with progression-free and/or overall survival [ Designated as safety issue: No ]
• Correlation of activated signal pathway molecules with response and/or survival [ Designated as safety issue: No ]

• Survival
• Functional and symptom status
• Correlation of epidermal growth factor receptor (EGFR) expression levels and/or EGFR polymorphisms with progression-free and/or overall survival
• Correlation of activated signal pathway molecules with response and/or survival

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

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer.

OBJECTIVES:

• Determine survival of patients with advanced primary non-small cell lung cancer and a Zubrod performance status of 2 treated with erlotinib.
• Determine the objective tumor response rates (confirmed, unconfirmed, complete, or partial) in patients treated with this drug.
• Determine functional and symptom status in patients treated with this drug.
• Determine the toxic effects of this drug in these patients.
• Correlate, preliminarily, epidermal growth factor receptor (EGFR) expression levels and/or EGFR polymorphisms with progression-free and/or overall survival in patients treated with this drug.
• Correlate, preliminarily, activated signal pathway molecules, including basal p27 expression levels, with response and/or survival in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 18 months.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria:

  • Selected stage IIIB disease (excluding Pancoast tumors)

    • T4 lesion due to malignant pleural effusion only
    • Any N
    • M0

  • Stage IV disease

    • Any T
    • Any N
    • M1
  • Recurrent disease after prior surgery and/or radiotherapy

• The following histologies are eligible:

  • Adenocarcinoma
  • Large cell carcinoma
  • Squamous cell carcinoma
  • Unspecified

• Measurable disease by CT scan, MRI, x-ray, or physical or nuclear exam

  • Measurable disease must be outside prior irradiated fields OR a new lesion must be present
  • Measurable disease must be outside the area of prior surgical resection

• No brain metastases

  • Negative CT scan or MRI if there are neurological abnormalities on physical exam or symptoms
• Patients must be offered participation in protocol SWOG-S9925 (Lung Cancer Specimen Repository study)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 2

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

• Bilirubin ≤ upper limit of normal (ULN) AND 1 of the following:

  • Alkaline phosphatase ≤ ULN AND SGOT OR SGPT ≤ 2 times ULN
  • Alkaline phosphatase ≤ 4 times ULN AND SGOT OR SGPT ≤ ULN

Renal

• Creatinine ≤ 2 mg/dL

Cardiovascular

• No significant history of cardiac disease
• No uncontrolled high blood pressure
• No unstable angina
• No congestive heart failure
• No cardiac ventricular arrhythmias requiring medication
• No myocardial infarction within the past 6 months

Gastrointestinal

• No GI tract disease resulting in an inability to take oral medication
• No malabsorption syndrome
• No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
• No requirement for IV alimentation

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy for NSCLC
• No concurrent biologic therapy

Chemotherapy

• No prior systemic chemotherapy for NSCLC

Endocrine therapy

• No prior hormonal therapy for NSCLC
• No concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy to measurable or non-measurable lesions

  • Concurrent palliative radiotherapy to small-field non-measurable sites of painful bony metastases allowed provided there are other sites of measurable disease outside of the radiotherapy treatment field

Surgery

• See Disease Characteristics
• At least 3 weeks since prior thoracic or other major surgeries and recovered
• No prior surgical procedures affecting gastrointestinal (GI) absorption

Other

• No prior epidermal growth factor receptor inhibitors