A Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors

Non-small Cell Lung Cancer Metastatic Clinical Trial

Official title:

A Real-world Non-interventional Observational Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors (TKIs) in the Patients With Non-small Cell Lung Cancer Complicated With Brain Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03424980
• Other study ID #: W-TONG03
• Status: Recruiting
• Phase: N/A
• First received: January 18, 2018
• Last updated: February 6, 2018
• Start date: December 31, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: February 2018
• Source: Tang-Du Hospital
• Contact: Haiying Yang, MD/PhD
• Phone: 0086-10-62680809
• Email: celineyang[@]linkdoc.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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;

Exclusion Criteria:

No exclusion criteria are included in the study given that the study is designed as non-interventional and all the treatments followed real-world clinical practice and experiences of clinical physicians.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Metastatic

Intervention

Combination Product:
• Tyrosine kinase inhibitors
Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors

Locations

Country	Name	City	State
China	China PLA General Hospital	Beijing	Beijing
China	Huaxi Hospital Affiliated to Sichuan University	Chengdu	Sichuan
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Tongji Hospital Affiliated to Huazhong Technology Hospital	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Tang-Du Hospital	LinkDoc Technology (Beijing) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients who are not observed with the event of overall survival	Percentage of patients who are not observed with the event of overall survival	2013 - 2017
Other	Percentage of patients with adverse events and serious adverse events	Percentages of patients with adverse events and serious adverse events (Percentages of the numbers of reported adverse events/total population * 100%)	2013 - 2017
Other	Severity of adverse events	Severity of adverse events	2013 - 2017
Primary	Percentage of patients who are not observed with the event of objective remission	Percentage of patients who are not observed with the event of objective remission	2013 - 2017
Secondary	Percentage of patients who are not observed with the event of disease progression	Percentage of patients who are not observed with the event of disease progression	2013 - 2017