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A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World.

NCT ID: NCT01955681

Last Updated: 2015-11-04

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

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-08-31

Brief Summary

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This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world.

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Detailed Description

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This study is designed to retrospectively review the medical and chemotherapy records of 300 patients with EGFR mutation positive adenocarcinoma NSCLC. Eligible patients are as follows: histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime after the failure of the initial EGFR-TKI. After initial treatment, patients had been treated with chemotherapy and subsequently re-treated with EGFR-TKI will be identified. The target population will be derived from multicentre in Taiwan. The study aim is to evaluate clinical effect in re-administration of EGFR-TKI using retrospectively collected data from these eligible patients to provide valuable information.

Conditions

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Locally Advanced or Metastatic EGFR Mutated NSCLC.

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Patients diagnosed with advanced adenocarcinoma or positive result of thyroid transcription factor 1 NSCLC
2. Positive Epidermal Growth Factor Receptor mutation result with sensitive mutation
3. Female or male aged ≧20 years

Exclusion Criteria

1\. Patients with EGFR mutation status of positive exon 20 T790M mutation only. 2. Patients who are confirmed of squamous type NSCLC
Minimum Eligible Age

20 Years

Maximum Eligible Age

150 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuh-Min Chen

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Gee-Chen Chang

Role: PRINCIPAL_INVESTIGATOR

Veterans General Hospital -Taichung

Chong-Jen Yu

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Cheng-Ta Yang

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Te-Chun Hsia

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Meng-Chih Lin

Role: PRINCIPAL_INVESTIGATOR

Chang-Gung Memorial Hospital Kaohsiung

Ying-Huang Tsai

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Chiayi

Locations

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Chiayi City, , Taiwan

Site Status

Kaohsiung City, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Research Site

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1850&filename=CSR_NIS-OTW-XXX-2013_1.pdf

CSR\_Synopsis\_NIS-OTW-XXX-2013\_1

Other Identifiers

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NIS-OTW-XXX-2013/1

Identifier Type: -

Identifier Source: org_study_id

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