A Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors

NCT ID: NCT03424980

Last Updated: 2018-02-08

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

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-31

Study Completion Date

2018-04-30

Brief Summary

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This is a real-world non-interventional observational study. The study was designed to evaluate the effectiveness and safety of clinical treatments in the patients with advanced non-small cell lung cancer (NSCLC) complicated with brain metastases in clinical practice.

Detailed Description

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This is a real-world non-interventional observational study that focuses to evaluate the effectiveness and safety of tyrosine kinase inhibitors (TKIs) in the patients of advanced non-small cell lung cancer (NSCLC) with brain metastases diagnosed by medical imaging methods. The patients with core medical health records who were enrolled in the clinics from 2014 to 2017 and were administered with TKIs only or combination therapies of TKIs will be included in the study. All the treatments followed real-world clinical practices and experiences of clinical physicians.

The effectiveness will be measured by the treatment effects on brain metastases (objective remission rate) and overall survival/progress-free survival. The safety will be evaluated by adverse events, serious adverse events, laboratory tests, electrocardiogram, vital sign, and physical examination. The mutation status of epidermal growth factor receptor (EGFR) and the type of anaplastic lymphoma kinase (ALK) will be assessed. All the study procedures will be in compliance with International Clinical Harmonization - Good Clinical Practice (ICH-GCP), standard operation procedures (SOPs), and regulatory policies/regulations.

Conditions

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Non-small Cell Lung Cancer Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Tyrosine kinase inhibitors

Diagnosed patients with advanced non-small cell lung cancer (NSCLC) with brain metastases who were administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors

Tyrosine kinase inhibitors

Intervention Type COMBINATION_PRODUCT

Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors

Interventions

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Tyrosine kinase inhibitors

Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* The patients were treated with lung cancer and were enrolled from Jan 2013 to Jun 2017
* The patients with advanced (Clinical stage: Phase IV) non-small cell lung cancer who have complete core health medical records (HMRs);
* The patients who are observed with brain metastases diagnosed by imaging methods;
* The patients who have complete clinical data for diagnosis time of brain metastases, and overall survival/effectiveness;
* The patients who are administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors;
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LinkDoc Technology (Beijing) Co. Ltd.

INDUSTRY

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Helong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helong Zhang

Role: PRINCIPAL_INVESTIGATOR

Xi'an Tangdu Hospital

Locations

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China PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Tongji Hospital Affiliated to Huazhong Technology Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Huaxi Hospital Affiliated to Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haiying Yang, MD/PhD

Role: CONTACT

0086-10-62680809

Chunya Zhang, MSc

Role: CONTACT

0086-10-62680809

Facility Contacts

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Yang Liu, PhD

Role: primary

0086-13501009331

Yin Li, PhD

Role: primary

0086-13903838752

Xiangning Fu, PhD

Role: primary

0086-13607150390

Heng Zhao

Role: primary

0086-13701865603

Lunxun Liu, PhD

Role: primary

0086-13608236600

Other Identifiers

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W-TONG03

Identifier Type: -

Identifier Source: org_study_id

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