A Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors

Tang-Du Hospital

Status: Unknown

Conditions: Non-small Cell Lung Cancer Metastatic

Treatments: Combination Product: Tyrosine kinase inhibitors

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03424980

W-TONG03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Tyrosine kinase inhibitors

Description:

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

Treatment:

Combination Product: Tyrosine kinase inhibitors