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.
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
200
Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors
China PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGTongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, China
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
Time frame: 2013 - 2017
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
Time frame: 2013 - 2017
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGHuaxi Hospital Affiliated to Sichuan University
Chengdu, Sichuan, China
RECRUITING