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

20 Years
74 Years
Open (Enrolling)
Non-small-cell Lung Cancer (NSCLC)

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Trial Information

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

Inclusion Criteria:

- presence of at least one measurable disease

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Description:

To assess overall response rate

Outcome Time Frame:

2 year

Safety Issue:



Taiwan: Taiwan Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

December 2014

Related Keywords:

  • Non-small-cell Lung Cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms