Non-small-cell Lung Cancer (NSCLC)
Conditions
Brief summary
Objectives: 1. 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 2. 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
Interventions
DRUGTS-1/Cisplatin
Sponsors
TTY Biopharm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | 2 year | To assess overall response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability | 2 year | To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability |
Countries
Taiwan
Outcome results
None listed