RecruitingPhase 2NCT06728852

Efficacy and Safety of Vorolanib Monotherapy As Third-line or Later Treatment for Advanced Non-small Cell Lung Cancer Patients: a Single-arm, Prospective, Open-label Phase II Clinical Study


Sponsor

Li-kun Chen

Enrollment

32 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study evaluates the efficacy and safety of Vorolanib as monotherapy for advanced non-small cell lung cancer (NSCLC) patients receiving third-line or higher treatments. It is a single-center, single-arm, prospective Phase II clinical trial. Thirty-two patients who have undergone at least two lines of systemic therapy and exhibited progression or recurrence will receive 300 mg of Vorolanib daily until disease progression, intolerable toxicity, withdrawal of consent, or death. The primary endpoint is the 6-month progression-free survival (PFS) rate. Secondary endpoints include PFS, objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. This research aims to expand the clinical applications of Vorolanib in NSCLC, providing a basis for further investigation.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study is testing vorolanib, an oral targeted therapy that blocks blood vessel growth in tumors, as a late-line treatment option for people with advanced non-small cell lung cancer (NSCLC) who have already tried at least two prior treatments. **You may be eligible if...** - You have confirmed advanced or metastatic NSCLC - You have already received at least two rounds of systemic cancer treatment (or cannot tolerate chemotherapy) - You are in reasonably good health (ECOG 0-2) and expected to live at least 3 months - Your blood counts, kidney, and liver function meet required levels - Your cancer does not have a targetable gene mutation, OR if it does, you have already been treated with the relevant targeted therapy **You may NOT be eligible if...** - You previously received a multi-target anti-angiogenic drug (like anlotinib or apatinib) - You have small cell lung cancer - You have active bleeding, unhealed wounds, or recent major surgery - You have had a blood clot, stroke, or serious heart or liver problem - You are pregnant, breastfeeding, or planning pregnancy - You have an active or uncontrolled infection, HIV, or hepatitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdministration of Vorolanib

This study utilizes Vorolanib, a novel angiogenesis inhibitor, as a monotherapy for advanced non-small cell lung cancer (NSCLC) patients who have failed at least two lines of systemic therapy. Vorolanib is administered orally at a dosage of 300 mg daily. The intervention focuses on its efficacy and safety as a third-line or beyond treatment, aiming to improve progression-free survival (PFS) and other clinical outcomes. Vorolanib targets VEGFR, PDGFR, and other tyrosine kinases, distinguishing it from other therapies by its enhanced anti-angiogenesis properties and tolerable safety profile in late-stage cancer treatment.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06728852


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