Rucaparib Monoclonal Antibody for Lorlatinib-Induced Hypercholesterolemia / Mixed

NCT07674368 | Not Yet Recruiting Phase 4

• 1 other identifier: MA-NSCLC-Ⅱ-059
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ALK Fusion-positive Non-small Cell Lung Cancer

Keywords

lunng cancer

Outcome Measures

Primary Outcomes (1)

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

  16 weeks after treatment initiation

Study Arms (1)

Recakimab Treatment Arm

EXPERIMENTAL

Drug: Recaticimab

Interventions

Recaticimab DRUG

Recaticimab (SHR-1209) injection, a fully human monoclonal antibody targeting PCSK9. All eligible subjects will receive subcutaneous injection of recaticimab 300 mg once every 8 weeks during the treatment period. The administration cycle will be maintained up to 32 weeks.

Recakimab Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with known hypersensitivity to the investigational product, or a history of severe hypersensitivity reactions to other antibody-based drugs;
• Diagnosed with familial hypercholesterolemia per the Simon Broome Criteria;
• Received other PCSK9 inhibitors within 6 months prior to screening;
• Uncontrolled hypercholesterolemia (total cholesterol above the upper limit of normal) existed before lorlatinib initiation;
• Prior diagnosis of New York Heart Association (NYHA) Class III-IV cardiac dysfunction;
• 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, peripheral atherosclerotic artery disease, etc.;
• Prior diagnosis of severe arrhythmia, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response;
• Uncontrolled hypertension at screening or randomization (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
• Prior diagnosis of diseases that significantly affect lipid levels, including nephrotic syndrome, severe liver disease, Cushing's syndrome, etc.;
• Prior diagnosis of Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus at screening (HbA1c \>8.5%);
• Active infectious disease at screening judged by the investigator to render the subject ineligible for trial participation;
• Participation in another interventional clinical trial within 1 month before screening (excluding screen failures), or within 5 half-lives of the investigational product at screening (whichever duration is longer);
• History of drug abuse, illicit substance use, or chronic alcohol abuse prior to screening;
• Major surgery within 3 months before screening, or planned major surgery during the study period;
• Chronic continuous or repeated systemic glucocorticoid use within 3 months prior to screening (topical administration excluded, e.g., intra-articular, intranasal, inhaled, cutaneous external use; chronic continuous use defined as ≥7 consecutive days; repeated use defined as cumulative administration ≥3 courses);

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Central Study Contacts

Xingxiang pu Pu

CONTACT

86-731-88651900; pxx_1354@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group (Single-arm) interventional study: All enrolled subjects will receive recakimab 300 mg subcutaneous injection every 8 weeks.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): July 10, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

CN (1)