Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC

Sponsor
Sun Yat-sen University
Study ID
NCT07674524
Status
Not Yet Recruiting

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Conditions

  • ALK Gene Mutation
  • ALK-positive
  • Hyperlipidemia
  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • For Part A - Observational Cohort: — DRUG
    No intervention assigned (observational)
  • Part B: Intensive Lipid-Lowering Group — DRUG
    Rosuvastatin + Ezetimibe + Evolocumab
  • For Part B - Intensive Group — DRUG
    Rosuvastatin + Ezetimibe

Study Details

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

Key Dates

First listed
Jun 29, 2026
Start date
Aug 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
160 participants (estimated)

Arms

  • Arm: Group/Cohort 1: Part A - Observational Cohort
    * Description: No intervention assigned. Real-world lipid-lowering treatment patterns recorded per routine clinical practice. May include statins, ezetimibe, PCSK9 inhibitors, or combinations. * Participants: \~100 * Intervention: None (observational)
  • Arm: Group/Cohort 2: Part B - Intensive Lipid-Lowering Group
    * Description: Intensive lipid-lowering therapy with rosuvastatin + ezetimibe + evolocumab (PCSK9 inhibitor) * Participants: 30 * Intervention: Rosuvastatin, Ezetimibe, Evolocumab
  • Arm: Group/Cohort 3: Part B - Standard Lipid-Lowering Group
    Active Comparator ,Patients with high CVD risk randomized to receive standard combination therapy. Rosuvastatin + Ezetimibe .

Primary Outcome Measure

Percentage Change in LDL-C from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]

Central Contacts

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