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The goal of this observational study is to learn about the long-term effects of Lorlatinib related hyperlipidemia in NSCLC patients who take Lorlatinib for at least 21 days. The main question it aims to answer is:
Participants already taking Lorlatinib as part of their regular medical care for NSCLC will answer online survey questions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorlatinib | Drug | To study hyperlipidemia frequency, levels, impact on cardiovascular events after use of Lorlatinib in NSCLC patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Alteration from baseline to 2 years after first dose of Lorlatinib: maximum carotid intima-media thickness and coronary CT calcification score. | Maximum carotid intima-media thickness: the higher the worse. It is a value directly determined under carotid ultrasound. CT: Computed Tomography Coronary CT calcification score: the higher the worse. It is a value directly determined by coronary calcium scan. | From first dose of Lorlatinib to 2 years thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers and Time of Major adverse cardiovascular events in patients with Lorlatinib-related hyperlipidemia. | From first dose of Lorlatinib to at maximum of 10 years thereafter. | |
| Comparison of predictive effect on MACE between change in maximum carotid intima-media thickness and coronary artery calcium score. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipid reduction among different lipid-lowering drugs in treating Lorlatinib-related hyperlipidemia. | From first dose of Lorlatinib to 2 years thereafter. | |
| Impact of lipid-lowering drugs on Lorlatinib efficacy. | The Lorlatinib efficacy is clinically measured as per RECIST1.1. Normally patients receiving Lorlatinib will undergo clinical routine CT scans every 1-2 months. Since this study is an observational study, we do not request the time interval for each round of CT scans-just as good as clinical routine. In this study, the Lorlatinib efficacy mainly refers to objective response rate(ORR), progression-free survival(PFS) and overall survival(OS). We aim to compare whether different lipid-lowering drugs may have different Lorlatinib efficacy in this prospective cohort. |
Inclusion Criteria:
Exclusion Criteria:
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Advanced NSCLC patients with ALK fusion positive who were treated with Lorlatinib as first- or later- line therapy will be enrolled from 10 tertiary hospitals in China.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China |
IPD will only be acquired by contacting investigator
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000590786 | lorlatinib |
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| From first dose of Lorlatinib to at maximum of 10 years thereafter. |
| From first dose of Lorlatinib to 2 years thereafter. |
| Correlation between the duration of lorlatinib-related hyperlipidemia and maximum of carotid intima-media thickness. | From first dose of Lorlatinib to 2 years thereafter. |
| Objective response rate (ORR) | The Lorlatinib efficacy is clinically measured as per RECIST1.1. Normally patients receiving Lorlatinib will undergo clinical routine CT scans every 1-2 months. Since this study is an observational study, we do not request the time interval for each round of CT scans-just as good as clinical routine. | From first dose of Lorlatinib to 2 years thereafter. |
| Progression-free Survival (PFS) | The Lorlatinib efficacy is clinically measured as per RECIST1.1. PFS is defined as the time from the first dose of Lorlatinib to disease progression. Normally patients receiving Lorlatinib will undergo clinical routine CT scans every 1-2 months. Since this study is an observational study, we do not request the time interval for each round of CT scans-just as good as clinical routine. | From first dose of Lorlatinib to at maximum of 10 years thereafter. |
| Overall Survival (OS) | The Lorlatinib efficacy is clinically measured as per RECIST1.1. OS is defined as the time from the first dose of Lorlatinib to the date of death. Normally patients receiving Lorlatinib will undergo clinical routine CT scans every 1-2 months. Since this study is an observational study, we do not request the time interval for each round of CT scans-just as good as clinical routine. | From first dose of Lorlatinib to at maximum of 10 years thereafter. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |