A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer

Inclusion Criteria: To be eligible for inclusion, each subject must fulfill all of the following criteria: 1. histologically or cytologically confirmed non-small cell bronchogenic carcinoma 2. Stage IIIb or IV disease 3. presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥20 mm with conventional CT/MRI or ≥10 mm with spiral CT scan 4. performance status of ECOG 0, 1 5. age between 20 and 74 years at registration 6. life expectancy of at least 12 weeks 7. ability to take the oral study medication (TS-1) 8. voluntarily signed the written informed consent form. Exclusion Criteria: * other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to the entry of study * previously received chemotherapy or therapy with systemic anti-tumor effect * significant co-morbid medical conditions, including, but not limited to , heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes * fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment * Presence of mental disease or psychotic manifestation * Participation in another clinical trial with any investigational drug within 30 days prior to entry * judged ineligible by physicians for participation in the study due to safety concern.