RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of non-small cell lung cancer.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES:

• Determine the 1-year survival, progression-free survival, and overall survival of patients with stage IIIB or IV bronchoalveolar carcinoma treated with gefitinib.
• Determine the frequency and severity of toxic effects of this drug in these patients.
• Determine the response rate in patients with measurable disease treated with this drug.
• Correlate epidermal growth factor receptor (EGFR) and EGFR variant III overexpression with clinical outcome in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic treatment for bronchoalveolar carcinoma (yes vs no). (The previously untreated stratum closed to accrual as of 2/15/2003.)

Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 90 patients (55 for the previously untreated stratum and 35 for the previously treated stratum) will be accrued for this study within 24 months. (The previously untreated stratum closed to accrual as of 2/15/2003.)

• West HL, Franklin WA, McCoy J, Gumerlock PH, Vance R, Lau DH, Chansky K, Crowley JJ, Gandara DR. Gefitinib therapy in advanced bronchioloalveolar carcinoma: Southwest Oncology Group Study S0126. J Clin Oncol. 2006 Apr 20;24(12):1807-13.
• Hirsch FR, Varella-Garcia M, McCoy J, West H, Xavier AC, Gumerlock P, Bunn PA Jr, Franklin WA, Crowley J, Gandara DR; Southwest Oncology Group. Increased epidermal growth factor receptor gene copy number detected by fluorescence in situ hybridization associates with increased sensitivity to gefitinib in patients with bronchioloalveolar carcinoma subtypes: a Southwest Oncology Group Study. J Clin Oncol. 2005 Oct 1;23(28):6838-45. Epub 2005 Jul 5.
• Gandara DR, West H, Chansky K, Davies AM, Lau DH, Crowley J, Gumerlock PH, Hirsch FR, Franklin WA. Bronchioloalveolar carcinoma: a model for investigating the biology of epidermal growth factor receptor inhibition. Clin Cancer Res. 2004 Jun 15;10(12 Pt 2):4205s-4209s. Review.

DISEASE CHARACTERISTICS:

• Histologically confirmed bronchoalveolar carcinoma

  • No fine needle aspirates or bronchial brushings or washings
  • Multi-focal or diffuse tumors
• Stage IIIB disease due to cytologically confirmed malignant pleural effusion OR
• Stage IV disease
• Evidence of disease by CT scan of chest
• Incompletely resected or unresectable disease
• No known brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• WBC at least 3,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
• Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if bone metastases present)

Renal:

• Not specified

Cardiovascular:

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

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No uncontrolled concurrent illness
• No ongoing or active infection
• No gastrointestinal tract disease that would preclude oral medication intake or cause requirement for IV alimentation
• No corneal inflammation or infection
• No psychiatric illness or social situation that would preclude study compliance
• 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:

• At least 4 weeks since prior biologic therapy
• No prior biologic therapy that targets epidermal growth factor receptor

Chemotherapy:

• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy
• No prior radiotherapy to areas of assessable disease

Surgery:

• See Disease Characteristics
• Recovered from prior surgery
• No prior surgical procedure affecting gastrointestinal absorption

Other:

• No other concurrent therapy for bronchoalveolar carcinoma
• No other concurrent investigational agents
• No concurrent agents that induce CYP3A4 (e.g., nafcillin, rifampin, carbamazepine, phenobarbital, phenytoin, and St. John's wort)