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| Name | Class |
|---|---|
| LinkDoc Technology (Beijing) Co. Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tyrosine kinase inhibitors | Combination Product | Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2013 - 2017 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who are not observed with the event of overall survival | 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 |
Inclusion Criteria:
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.
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiying Yang, MD/PhD | Contact | 0086-10-62680809 | celineyang@linkdoc.com | |
| Chunya Zhang, MSc | Contact | 0086-10-62680809 | violazhang@linkdoc.com |
| Name | Affiliation | Role |
|---|---|---|
| Helong Zhang | Xi'an Tangdu Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000092004 | Tyrosine Kinase Inhibitors |
| ID | Term |
|---|---|
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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Percentages of patients with adverse events and serious adverse events (Percentages of the numbers of reported adverse events/total population * 100%)
| 2013 - 2017 |
| Severity of adverse events | Severity of adverse events | 2013 - 2017 |
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
|
| Tongji Hospital Affiliated to Huazhong Technology Hospital | Recruiting | Wuhan | Hubei | 430030 | China |
|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
|
| Huaxi Hospital Affiliated to Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020164 | Chemical Actions and Uses |