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

Inclusion criteria

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