Gefitinib as First-Line Therapy Followed by Gemcitabine and Cisplatin 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 (NSCLC), including any of the following cellular subtypes:
• * Squamous cell carcinoma
• * Adenocarcinoma
• * Large cell carcinoma
• * Poorly differentiated NSCLC NOTE: \*New biopsies or cytologic specimens required for primary resection specimens older than 2 years
• De novo or recurrent disease, meeting 1 of the following stage criteria:
• * Stage IIIB disease
• * Malignant pleural effusion OR supraclavicular node involvement (N3)
• * Not suitable for curative multimodal treatment or surgery
• * Stage IV disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI
• * Measurable lesion must be outside previously irradiated areas
• Immediate chemotherapy is not clinically mandatory
• No small cell lung cancer (SCLC) or SCLC combined with NSCLC
• No symptomatic and/or untreated brain metastases
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• WHO 0-1
• Life expectancy
• Not specified
• Hematopoietic
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 10.0 g/dL
• Hepatic
• Bilirubin normal
• AST or ALT ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN in the presence of bone metastases)
• No unstable or uncompensated hepatic disease
• Renal
• Creatinine clearance \> 60 mL/min
• No unstable or uncompensated renal disease
• Cardiovascular
• No unstable or uncompensated cardiac disease
• No myocardial infarction within the past 3 months
• Pulmonary
• No clinically active interstitial lung disease
• * Asymptomatic patients with chronic stable radiographic changes allowed
• No unstable or uncompensated respiratory disease
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 12 months after completion of study treatment
• Able to swallow and retain oral medication
• No active infection
• No uncontrolled diabetes mellitus
• No history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biological composition to study drugs
• No other severe or uncontrolled systemic disease
• No other serious underlying medical condition that would preclude study participation
• No psychiatric disability that would preclude study compliance or giving informed consent
• No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• Prior intrapleural or intrapericardial local chemotherapy allowed
• No prior chemotherapy for advanced disease
• More than 6 months since prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC
• Endocrine therapy
• Not specified
• Radiotherapy
• See Disease Characteristics
• Concurrent palliative radiotherapy allowed (except to brain metastases)
• Surgery
• Not specified
• Other
• No prior epidermal growth factor receptor-targeted therapy for NSCLC
• No concurrent use of any of the following CYP3A4 inducers:
• * Phenytoin
• * Carbamazepine
• * Rifampin
• * Barbiturates
• * Hypericum perforatum (St. John's wort)
• More than 30 days since prior participation in another clinical trial
• No other concurrent investigational agent