NCT03424980

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Non-small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Tyrosine kinase inhibitors	Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors

Timeline

• Start date: 2017-12-31
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2018-02-07
• Last updated: 2018-02-08

Locations

5 sites across 1 country: China

Regulatory

• FDA-regulated drug study