A Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors

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

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer Metastatic
• Intervention / Treatment: Combination product: Tyrosine kinase inhibitors

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Haiying Yang, MD/PhD; Phone Number: 0086-10-62680809; Email: celineyang@linkdoc.com
• Study Contact Backup: Name: Chunya Zhang, MSc; Phone Number: 0086-10-62680809; Email: violazhang@linkdoc.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • China PLA General Hospital
      • Contact: Yang Liu, PhD; Phone Number: 0086-13501009331; Email: sunny301x@sina.com
      • Principal Investigator: Yang Liu, PhD
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Yin Li, PhD; Phone Number: 0086-13903838752; Email: liyin825@aliyun.com
      • Principal Investigator: Yin Li, PhD
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital Affiliated to Huazhong Technology Hospital
      • Contact: Xiangning Fu, PhD; Phone Number: 0086-13607150390; Email: Fuxn2006@aliyun.com
      • Principal Investigator: Xiangning Fu, PhD
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Heng Zhao; Phone Number: 0086-13701865603; Email: h_zhao28@163.com
      • Principal Investigator: Heng Zhao, PhD
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Huaxi Hospital Affiliated to Sichuan University
      • Contact: Lunxun Liu, PhD; Phone Number: 0086-13608236600; Email: lunxu_liu@aliyun.com
      • Principal Investigator: Lunxun Liu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The target study population is defined as the patients who were diagnosed with advanced non-small cell lung cancer (NSCLC) with brain metastases and were treated with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors following real-world clinical practice and experiences of clinical physicians

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Combination product: Tyrosine kinase inhibitors; Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Severity of adverse events	Severity of adverse events	2013 - 2017

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Collaborators: LinkDoc Technology (Beijing) Co. Ltd.
• Investigators: Principal Investigator: Helong Zhang, Xi'an Tangdu Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2017
• Primary Completion (Anticipated): April 30, 2018
• Study Completion (Anticipated): April 30, 2018

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer, Chinese, brain metastases
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: W-TONG03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No