Clinical trial · Observational
LORLATINIB-related HYPERLIPIDEMIA in ALK+ Non-Small Cell Lung Cancer
Multicenter Cohort Study of LORLATINIB-related HYPERLIPIDEMIA in ALK+ Advanced Non-Small Cell Lung Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: * Whether blood lipids have been lowered down to an anticipated level within recommended range after the initial revealed Lorlatinib related hyperlipidemia? * Will it be harmful to the cardiovascular system when blood lipids were not lowered down to normal levels in these cancer patients treated with Lorlatinib, i.e. major adverse cardiac events (MACE), or instead, carotid artery intima-media thickness. Participants already taking Lorlatinib as part of their regular medical care for NSCLC will answer online survey questions.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperlipidemia | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lorlatinib | Drug | Lorlatinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Alteration from baseline to 2 years after first dose of Lorlatinib: maximum carotid intima-media thickness and coronary CT calcification score.
- timeFrame
- From first dose of Lorlatinib to 2 years thereafter.
- description
- 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.
Secondary outcomes (2)
- measure
- Numbers and Time of Major adverse cardiovascular events in patients with Lorlatinib-related hyperlipidemia.
- timeFrame
- From first dose of Lorlatinib to at maximum of 10 years thereafter.
- measure
- Comparison of predictive effect on MACE between change in maximum carotid intima-media thickness and coronary artery calcium score.
- timeFrame
- From first dose of Lorlatinib to at maximum of 10 years thereafter.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced ALK+ NSCLC diagnosed by patholgy and/or cytology * ECOG 0-2 * Age 18-80 years * Taken Lorlatinib for at least 20 days * Signed informed consent. Exclusion Criteria: * Treatment with other anti-cancer drugs during Lorlatinib treatment
References
Publications (0)
Data not yet available