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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin for Non-Small Cell Lung Cancer (NSCLC)

NCT00154739

Non-Small Cell Lung Cancer

COMPLETED PHASE2

A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer

NCT03100955

Progression Free Survival

UNKNOWN PHASE3

Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type

NCT02906150

Non-Small Cell Lung Cancer

UNKNOWN PHASE2

Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients

NCT06071013

Non-small Cell Lung Cancer EGFR Gene Mutation EGFR-TKI Resistant Mutation

RECRUITING PHASE1/PHASE2

Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer

NCT00546130

Small Cell Lung Cancer

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-small-cell Lung Cancer (NSCLC)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TS-1/Cisplatin

single arm

Group Type EXPERIMENTAL

TS-1/Cisplatin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TS-1/Cisplatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No