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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Sponsor
- Tang-Du Hospital
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- Percentage of patients who are not observed with the event of objective remission
- Last Updated
- 8 years ago
Overview
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.
Investigators
Zhang Helong
Professor
Tang-Du Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Percentage of patients who are not observed with the event of objective remission
Time Frame: 2013 - 2017
Percentage of patients who are not observed with the event of objective remission
Secondary Outcomes
- Percentage of patients who are not observed with the event of disease progression(2013 - 2017)