Clinical trial NCT03424980: A Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer Metastatic
Keywords: Non-small cell lung cancer, Chinese, brain metastases
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2018-02-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target study population is defined as the patients who were diagnosed with advanced non-small cell lung cancer (NSCLC) with brain metastases and were treated with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors following real-world clinical practice and experiences of clinical physicians

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.

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.

Primary outcomes:
measure: Percentage of patients who are not observed with the event of objective remission
timeFrame: 2013 - 2017
Secondary outcomes:
measure: Percentage of patients who are not observed with the event of disease progression
timeFrame: 2013 - 2017
Other outcomes:
measure: Percentage of patients who are not observed with the event of overall survival
timeFrame: 2013 - 2017
measure: Percentage of patients with adverse events and serious adverse events
timeFrame: 2013 - 2017
measure: Severity of adverse events
timeFrame: 2013 - 2017
Locations:
city: Beijing
country: China
facility: China PLA General Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Huazhong Technology Hospital
state: Hubei
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Chengdu
country: China
facility: Huaxi Hospital Affiliated to Sichuan University
state: Sichuan
Study officials:
affiliation: Xi'an Tangdu Hospital
name: Helong Zhang
role: PRINCIPAL_INVESTIGATOR
References: