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

Study Overview
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Brief Summary
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Objectives: 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

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

Conditions
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Non-small-cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Drug: TS-1/Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for inclusion, each subject must fulfill all of the following criteria: histologically or cytologically confirmed non-small cell bronchogenic carcinoma Stage IIIb or IV disease 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 performance status of ECOG 0, 1 age between 20 and 74 years at registration life expectancy of at least 12 weeks ability to take the oral study medication (TS-1) 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TS-1/Cisplatin<br>single arm | Drug: TS-1/Cisplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate | To assess overall response rate | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability | To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability | 2 year |