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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TTY Biopharm
• Treatments: Cisplatin

Criteria

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.