Not Yet RecruitingPhase 4

Rucaparib Monoclonal Antibody for Lorlatinib-Induced Hypercholesterolemia / Mixed

China29 participantsStarted 2026-07-10

Plain-language summary

This prospective single-arm clinical study plans to enroll 29 participants with unresectable stage IIIB-IV ALK fusion-positive non-small cell lung cancer (NSCLC). Eligible patients must be aged ≥18 years with an ECOG performance status of 0-2 and have developed grade 1-3 hypercholesterolemia adverse events (AEs, per CTCAE 5.0) after lorlatinib treatment. All subjects will receive recakimab 300 mg administered once every 8 weeks. The primary endpoint is the percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 16. Secondary endpoints include absolute change in LDL-C at week 16; percentage and absolute change in LDL-C at week 32; percentage and absolute changes from baseline in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol/HDL-C ratio, ApoB/apolipoprotein A1 (ApoA1) ratio, lipoprotein(a) \[Lp(a)\] and triglycerides (TG) at weeks 16 and 32; proportion of patients whose hypercholesterolemia AEs return to normal at weeks 16 and 32; LDL-C target achievement rate at weeks 16 and 32; and safety profile related to recakimab.

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:Aged ≥ 18 years on the day of signing the informed consent form, with no gender restriction; Patients with unresectable stage IIIB/IIIC/IV non-small cell lung cancer (NSCLC) confirmed by cytology or histology (staging defined per the 9th edition of the International Association for the Study of Lung Cancer (IASLC) Staging Manual in Thoracic Oncology); Positive ALK fusion confirmed by genetic testing; Developed Grade 1-3 hypercholesterolemia adverse events after lorlatinib treatment (per CTCAE Version 5.0); Fasting triglyceride level ≤ 5.6 mmol/L at screening; Willing and able to comply with scheduled study visits, treatment regimens, laboratory tests and all other study procedures. \- Exclusion Criteria:(1) Subjects with known hypersensitivity to the investigational product, or a history of severe hypersensitivity reactions to other antibody-based drugs; (2) Diagnosed with familial hypercholesterolemia per the Simon Broome Criteria; (3) Received other PCSK9 inhibitors within 6 months prior to screening; (4) Uncontrolled hypercholesterolemia (total cholesterol above the upper limit of normal) existed before lorlatinib initiation; (5) Prior diagnosis of New York Heart Association (NYHA) Class III-IV cardiac dysfunction; (6) Prior diagnosis of atherosclerotic cardiovascular disease (ASCVD), including acute coronary syndrome, stable coronary artery disease, post-revascularization status, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, per…

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

Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 16

Timeframe: 16 weeks after treatment initiation

Trial details

NCT IDNCT07674368

SponsorHunan Cancer Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-10

Contact for this trial

Xingxiang pu Pu

86-731-88651900 pxx_1354@163.com

View on ClinicalTrials.gov More ALK Fusion-positive Non-small Cell Lung Cancer trials