A Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors

NCT03424980 | Unknown FDA Drug

• 1 other identifier: W-TONG03
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Non-small Cell Lung Cancer Metastatic

Keywords

Non-small cell lung cancer, Chinese, brain metastases

Outcome Measures

Primary Outcomes (1)

• 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

  2013 - 2017

Secondary Outcomes (1)

• Percentage of patients who are not observed with the event of disease progression

  2013 - 2017

Other Outcomes (3)

• Percentage of patients who are not observed with the event of overall survival

  2013 - 2017

• Percentage of patients with adverse events and serious adverse events

  2013 - 2017

• Severity of adverse events

  2013 - 2017

Study Arms (1)

Tyrosine kinase inhibitors

Diagnosed patients with advanced non-small cell lung cancer (NSCLC) with brain metastases who were administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors

Combination Product: Tyrosine kinase inhibitors

Interventions

Tyrosine kinase inhibitors COMBINATION_PRODUCT

Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors

Tyrosine kinase inhibitors

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;

Sponsors & Collaborators

• Tang-Du Hospital: lead
• LinkDoc Technology (Beijing) Co. Ltd.: collaborator

Study Sites (5)

China PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Tongji Hospital Affiliated to Huazhong Technology Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Huaxi Hospital Affiliated to Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

Tyrosine Kinase Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Helong Zhang

  Xi'an Tangdu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiying Yang, MD/PhD

CONTACT

0086-10-62680809; celineyang@linkdoc.com

Chunya Zhang, MSc

CONTACT

0086-10-62680809; violazhang@linkdoc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 7, 2018
• Study Start: December 31, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)