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