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Rucaparib Monoclonal Antibody for Lorlatinib-Induced Hypercholesterolemia / Mixed

NCT07674368 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-07-01

No results posted yet for this study

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

Interventions

DRUG

Recaticimab

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.

Sponsors & Collaborators

  • Hunan Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-10
Primary Completion
2028-07-10
Completion
2028-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07674368 on ClinicalTrials.gov