Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC (NCT07674524) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC
China160 participantsStarted 2026-08-01
Plain-language summary
For Patients and Families
Brief Title: Management of 1L Lorlatinib with Hyperlipidemia in ALK+ Advanced NSCLC
What is this study about?
This study is for people with ALK-positive non-small cell lung cancer (NSCLC) who are taking lorlatinib (Lorbrena®) as their first treatment and have developed high cholesterol (hyperlipidemia) as a side effect.
Why is this study needed?
Lorlatinib is a highly effective targeted therapy, but it frequently causes elevated cholesterol and triglycerides. There is currently no standard guideline on how to best manage this side effect. This study aims to find the best approach to control lipid levels while on lorlatinib treatment.
What will happen in this study?
The study has two parts:
* Part A (Observational) : About 100 participants. Doctors manage hyperlipidemia according to routine clinical practice. Researchers simply observe and record which lipid-lowering treatments are used and how well they work.
* Part B (Randomized Controlled Trial) : 60 participants with high-risk factors are randomly assigned to either:
* Intensive treatment: rosuvastatin + ezetimibe + evolocumab
* Standard treatment: rosuvastatin + ezetimibe
What tests are involved?
* Blood tests for lipid levels at baseline, Weeks 4, 8, 20, and 24
* Routine CT or MRI scans for tumor assessment
* Some participants in Part B may have a non-invasive vascular ultrasound (FMD) test
* Total participation per patient: up to 7 months
Is this study safe?
* ✅ Approved by the Ethics Committee of Sun Yat-sen University Cancer Center
* ✅ All drugs used (lorlatinib, statins, ezetimibe, evolocumab) are already approved and widely used
* ✅ An independent Data Monitoring Committee (DMC) monitors safety throughout the study
* ✅ Participants may withdraw at any time without affecting their regular care
For Healthcare Providers
Study Title: Management strategy of 1L Lorlatinib with Hyperlipidemia in Stage IIIB-IV ALK positive NSCLC: A multi-center prospective study in China
Sponsor / Investigators: Sun Yat-sen University Cancer Center (PI: Prof. Zhang Li)
Study Type:
* Part A: Observational, prospective, real-world cohort study
* Part B: Prospective, randomized controlled trial (RCT)
Estimated Enrollment: 160 participants (Part A: \~100, Part B: 60)
Study Duration: Approximately 4 years (anticipated completion: December 2029)
Key Inclusion Criteria:
* Stage IIIB-IV ALK+ NSCLC (confirmed by IHC, FISH, PCR, NGS, or ctDNA)
* No prior systemic therapy for advanced/metastatic disease
* ECOG PS 0-2
* Age ≥ 18 years
* Hyperlipidemia (ULN ≤ TC \< 12.93 mmol/L, Grade 1-3) while on first-line lorlatinib
* At least one measurable lesion per RECIST v1.1
* Life expectancy ≥ 6 months
Primary Endpoints:
* Part A: Describe real-world treatment patterns for hyperlipidemia management
* Part B: Percentage change in LDL-C from baseline to Week 12
Oversight:
* Independent Data Monitoring Committee (DMC)
* Trial Management Committee
* Ethics Committee of Sun Yat-sen University Cancer Center (Approval No. B2026-159-01)
Participating Centers: 8 sites across China
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis:
. Histologically or cytologically confirmed locally advanced \[defined as Stage IIIB/C per AJCC v7.0 and not amenable to multimodality treatment\] or metastatic (Stage IV) ALK-positive NSCLC; ALK status must be confirmed by Ventana ALK (D5F3) Companion Diagnostic (CDx) IHC (Ventana ULTRA or XT platform), FISH, PCR, next-generation sequencing (NGS), or circulating tumor DNA (ctDNA) testing;
. At least one measurable target lesion per RECIST v1.1, not previously irradiated; brain metastases are allowed;
. No prior systemic therapy for advanced (Stage IIIB/C not amenable to multimodality treatment) or metastatic (Stage IV) disease;
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2;
. Age ≥ 18 years;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage Change in LDL-C from Baseline to Week 12
Timeframe: Baseline, Week 12
2
Real-World Treatment Patterns for Hyperlipidemia Management
Timeframe: Baseline through Week 24 (measured at Baseline, Weeks 4, 8, 20, and 24)
. Hyperlipidemia during first-line lorlatinib treatment, with ULN ≤ TC \< 12.93 mmol/L (Grade 1-3);
. Life expectancy ≥ 6 months;
Exclusion criteria
. Mixed squamous cell carcinoma, large cell carcinoma, or small cell lung cancer
. Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
. Diagnosed genetic hypercholesterolemia (e.g., familial hypercholesterolemia, Part A only) or secondary dyslipidemia with a clear etiology (e.g., hypothyroidism, uncontrolled diabetes, nephrotic syndrome)
. Known allergy or history of severe adverse reaction to any study drug (including lorlatinib, statins, ezetimibe, or evolocumab)
. Presence of other severe diseases that may affect study compliance or outcome assessment, including advanced renal failure (eGFR \< 30 mL/min/1.73 m²) or severe hepatic impairment (Child-Pugh Class C)
. Pregnant or lactating women, or fertile individuals (male or female) unwilling to use effective contraception during the study
. Currently participating in another interventional clinical study that may interfere with this study; patients expected to be unable to complete follow-up or the first tumor efficacy assessment; patients with mental or psychological disorders who cannot provide informed consent or comply with study requirements (including treatment and follow-up)
. Major surgery within 4 weeks prior to randomization; minor surgery (e.g., port placement) is permitted provided the incision is adequately healed