Gefitinib as First-Line Therapy Followed by Gemcitabine and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

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