Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed non-small cell lung cancer
• * Advanced disease (stage IIIB or IV)
• * Diagnosis within 62 days prior to randomization
• Not suitable for first-line chemotherapy, as defined by the following criteria\*:
• * ECOG performance status 2-3
• * ECOG performance status 0-1 AND creatinine clearance \< 60 mL/min
• NOTE: \*These criteria do not imply that all such patients are unsuitable for chemotherapy; patients are considered unsuitable on a case by case basis
• No symptomatic brain metastases
• PATIENT CHARACTERISTICS:
• Estimated life expectancy of at least 8 weeks
• Able to take oral medication
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No severe uncontrolled infection
• No unstable angina
• No myocardial infarction within the past month
• No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
• No acute renal failure
• Bilirubin \< 2 times upper limit of normal (ULN)
• Transaminases \< 2 times ULN (5 times ULN if liver metastases are present)
• Creatinine \< 5 times ULN
• No evidence of other significant laboratory finding or uncontrolled medical illness that would interfere with study treatment or results comparison or render the patient at high risk from treatment complications
• No other prior or current malignant disease likely to interfere with study treatment or comparisons
• PRIOR CONCURRENT THERAPY:
• No prior chemotherapy
• No prior biological anticancer therapy (e.g., gefitinib, thalidomide, or cetuximab)
• No prior palliative radiotherapy
• * Prior palliative radiotherapy to bone metastases allowed within the past 2 weeks
• No concurrent cyclooxygenase-2 inhibitors