A Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors

• Conditions: Non-small Cell Lung Cancer Metastatic
• Interventions: Combination Product: Tyrosine kinase inhibitors

• Registration Number: NCT03424980
• Lead Sponsor: Tang-Du Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-12-31
• Study First Submitted: 2018-01-18
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-05
• Last Update Submitted: 2018-02-06
• Study First Posted: 2018-02-07
• Last Update Posted: 2018-02-08
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tyrosine kinase inhibitors	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

Primary Outcome Measures

Name	Time	Method
Percentage of patients who are not observed with the event of objective remission	2013 - 2017	Percentage of patients who are not observed with the event of objective remission

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who are not observed with the event of disease progression	2013 - 2017	Percentage of patients who are not observed with the event of disease progression

Trial Locations

Locations (5)

Huaxi Hospital Affiliated to Sichuan University; 🇨🇳 Chengdu, Sichuan, China

China PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital Affiliated to Huazhong Technology Hospital; 🇨🇳 Wuhan, Hubei, China