NSCLC

Primary Objective: To bridge the data of efficacy in term of overall response rate of TS-1 plus cisplatin in Taiwanese advanced NSCLC patients from that gained from Japanese population. Secondary Objectives: A. To assess progression free survival B. To assess overall survival C. To bridge the safety profile by assessing the toxicities and tolerability

TS-1

TS-1

capsule

20, 25

Primary Endpoints:
To assess overall response rate

Secondary Endpoints:
To assess progression free survival
To assess overall survival
To bridge the safety profile by assessing the toxicities and tolerability

Inclusion Criteria:
To be eligible for inclusion, each subject must fulfill all of the following criteria:
a. histologically or cytologically confirmed non-small cell bronchogenic carcinoma.
b. Stage IIIb or IV disease
c. 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.
d. performance status of ECOG 0, 1
e. age between 20 and 74 years at registration.
f. life expectancy of at least 12 weeks.
g. ability to take the oral study medication (TS-1).
h. voluntarily signed the written informed consent form.

Exclusion Criteria:
Subjects who fulfill any of the following criteria will be excluded from the trial:
a. mixed type lung carcinoma (non-small cell plus small cell lung
cancer)
b. presence of CNS metastasis
c. 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.
d. previously received chemotherapy or therapy with systemic
anti-tumor effect.
e. less than 4 weeks since previous radiotherapy or 2 weeks since
previous thoracotomy.
f. presence of diarrhea ≧ common terminology criteria for adverse events v4.0 (CTCAE v4.0) grade 2.
g. inadequate hematopoietic function which is defined as below:
(i) white blood cell (WBC) less than 3,500/mm3
(ii)absolute neutrophil count (ANC) less than 1,500/mm3
(iii) platelets less than 100,000/mm3
(iv) hemoglobin level less than 9 g/dl
h. inadequate hepatic function which is defined as below:
(i) serum bilirubin greater than 1.5 mg/dl
(ii) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases.
i. Inadequate renal function which is defined as serum creatinine
greater than 1 time the ULN or creatinine clearance equal to or less than 60 ml/min (based upon 24-hour urine collection or calculated by Cockroft-Gault formula)
j. partial pressure of arterial oxygen (PaO2) less than 60 Torr or
saturation of pulse oximetry oxygen (SpO2) less than 93%
k. presence of symptomatic peripheral neuropathy greater than grade 1.
l. significant co-morbid medical conditions, including, but not limited to, heart failure, renal failure, hepatic failure, hemorrhagic pepticulcer, mechanical or paralytic ileus, or poorly controlled diabetes.
m. receiving a concomitant treatment with drugs interacting with TS-1 and/or Cisplatin. The following drugs are prohibited due to possible interactions with TS-1 and/or cisplatin:
(i) phenytoin
(ii) warfarin
(iii) flucytosine
(iv) aminoglycosides
(v) aminophylline
n. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients of childbearing age
should have effective contraception for both the patient and his or
her partner during the study period.
o. Presence of mental disease or psychotic manifestation
p. participation in another clinical trial with any investigational drug within 30 days prior to entry.
q. judged ineligible by physicians for participation in the study due to safety concern.