A Randomized, Double Blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSA) in Combination With Gemcitabine and Cisplatin Versus Placebo in Combination With Gemcitabine and Cisplatin in Chemotherapy Naive Patients With Advanced (Stage III or IV) Non-Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven non-small cell lung cancer Stage III
disease that is not curable with surgery or radiotherapy OR Stage IV disease Chemotherapy
naive

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 WBC at least
4,000/mm3 Hepatic: ALT and AST less than 2.5 times upper limit of normal (ULN) (less than
5 times ULN if liver metastasis present) Bilirubin less than 1.25 times ULN Renal:
Creatinine less than 1.5 times ULN Creatinine clearance greater than 60 mL/min
Cardiovascular: No evidence of severe or uncontrolled cardiovascular disease Pulmonary: No
evidence of severe or uncontrolled pulmonary disease

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: No concurrent systemic endocrine therapy that is known
to have an effect on non-small cell lung cancer Radiotherapy: See Disease Characteristics
Prior localized irradiation allowed Surgery: See Disease Characteristics Prior surgery
allowed Other: No concurrent drugs with known significant cytochrome P450 3A4 inhibitory
effects (e.g., ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem,
verapamil)