NCT06728852

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Li-kun Chen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Non-small Cell Lung Cancer (NSCLC)
• Recurrent or Metastatic Lung Cancer
• Third-line and Beyond Therapy
• Angiogenesis Inhibition in Oncology

Interventions

Type	Name	Description
DRUG	Administration 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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-12-11
• Last updated: 2024-12-11

Locations

1 site across 1 country: China