Non-small Cell Lung Cancer Metastatic
Conditions
Keywords
Non-small cell lung cancer, Chinese, brain metastases
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.
Interventions
COMBINATION_PRODUCTTyrosine kinase inhibitors
Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors
Sponsors
LinkDoc Technology (Beijing) Co. Ltd.
Tang-Du Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who are not observed with the event of objective remission | 2013 - 2017 | Percentage of patients who are not observed with the event of objective remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who are not observed with the event of disease progression | 2013 - 2017 | Percentage of patients who are not observed with the event of disease progression |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who are not observed with the event of overall survival | 2013 - 2017 | Percentage of patients who are not observed with the event of overall survival |
| Percentage of patients with adverse events and serious adverse events | 2013 - 2017 | Percentages of patients with adverse events and serious adverse events (Percentages of the numbers of reported adverse events/total population \* 100%) |
| Severity of adverse events | 2013 - 2017 | Severity of adverse events |
Countries
China
Contacts
Primary ContactHaiying Yang, MD/PhD
Backup ContactChunya Zhang, MSc
Outcome results
None listed