Non-Small Cell Lung CancerNCT06876675
LORLATINIB-related HYPERLIPIDEMIA in ALK+ Non-Small Cell Lung Cancer
An observational study of Non-Small Cell Lung Cancer and Hyperlipidemia, run by Peking University Third Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Hyperlipidemia
- What is being tested?
- Lorlatinib
- How many people
- 167 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to Aug 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Treatment with other anti-cancer drugs during Lorlatinib treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multicenter Cohort Study of LORLATINIB-related HYPERLIPIDEMIA in ALK+ Advanced Non-Small Cell Lung Cancer Patients
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
- Non-Small Cell Lung Cancer, Hyperlipidemia
- Being tested
- Lorlatinib
- Keywords
- NSCLC, Hyperlipidemia, Lorlatinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorlatinibDrug
To study hyperlipidemia frequency, levels, impact on cardiovascular events after use of Lorlatinib in NSCLC patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose of Lorlatinib to 2 years thereafter.
Secondary outcomes (2)
Numbers and Time of Major adverse cardiovascular events in patients with Lorlatinib-related hyperlipidemia.
Measured: 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.
Measured: From first dose of Lorlatinib to at maximum of 10 years thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start15 Oct 2024
- Primary completionSep 2025 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Liang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876675
- Sponsor's protocol ID
- (2024)696-02
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be acquired by contacting investigator
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Cohort Study of LORLATINIB-related HYPERLIPIDEMIA in ALK+ Advanced Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06876675
- Acronym / sponsor ID
- (2024)696-02
- Conditions
- Non-Small Cell Lung Cancer, Hyperlipidemia
- Keywords
- NSCLC, Hyperlipidemia, Lorlatinib
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Treatment with other anti-cancer drugs during Lorlatinib treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorlatinibTo study hyperlipidemia frequency, levels, impact on cardiovascular events after use of Lorlatinib in NSCLC patients. | Drug | – |
Primary outcome
Alteration from baseline to 2 years after first dose of Lorlatinib: maximum carotid intima-media thickness and coronary CT calcification score.
Time frame: From first dose of Lorlatinib to 2 years thereafter.
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.
2 secondary outcomes
Numbers and Time of Major adverse cardiovascular events in patients with Lorlatinib-related hyperlipidemia.
Time frame: 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.
Time frame: From first dose of Lorlatinib to at maximum of 10 years thereafter.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No. IPD will only be acquired by contacting investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer and Hyperlipidemia, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alteration from baseline to 2 years after first dose of Lorlatinib: maximum carotid intima-media thickness and coronary CT calcification score. (time frame: From first dose of Lorlatinib to 2 years thereafter.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.