An Open Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically and/or cytologically confirmed non-small cell lung cancer (NSCLC)
meeting 1 of the following criteria:

- Stage IIIB disease with pleural effusion or pericardial effusion

- Stage IV disease

- Unresectable disease

- No mixed histologies of small cell lung cancer

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- No symptomatic, uncontrolled (by corticosteroids) brain metastases

- No leptomeningeal metastasis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

Hepatic

- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver
metastasis)

- Bilirubin ≤ 1.5 times ULN

Renal

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No myocardial infarction within the past 6 months

- No severe or unstable angina

- No New York Heart Association class III or IV congestive heart failure

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after study
completion

- No known HIV- or AIDS-related illness

- No known hypersensitivity to cisplatin

- Able to take oral medication

- No other active malignancy

- No peripheral neuropathy > grade 2

- No chronic nausea, vomiting, and/or diarrhea

- No psychiatric disorder that would preclude study compliance

- No other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy

- No concurrent biologic response modifiers

Chemotherapy

- More than 12 months since prior cytotoxic chemotherapy except for adjuvant or
neoadjuvant therapy for NSCLC

- No prior cisplatin as neoadjuvant and/or adjuvant chemotherapy with a cumulative dose
> 300 mg/m^2

- No other concurrent chemotherapy

- No fluoropyrimidine-group antineoplastic agents within 7 days after the last dose of
S-1

Endocrine therapy

- See Disease Characteristics

- No concurrent endocrine therapy

Radiotherapy

- More than 2 weeks since prior radiotherapy

- No prior radiotherapy to a target lesion unless there is subsequent evidence of
disease progression and it is not the only site of measurable disease

- No concurrent radiotherapy

Surgery

- Not specified

Other

- More than 12 months since prior adjuvant or neoadjuvant therapy

- More than 30 days since prior investigational agents

- No other concurrent investigational agent

- No concurrent enrollment in another clinical trial

- No other concurrent anticancer therapy

- No concurrent administration of any of the following:

- Sorivudine

- Uracil

- Cimetidine

- Leucovorin calcium

- Dipyridamole

- Allopurinol

- Phenytoin

- Flucytosine

- Aminoglycosides (avoid within 8 days after cisplatin)

- Amifostine

- No other concurrent drugs that interact with study treatment

- No flucytosine within 7 days after the last dose of S-1