Actively Recruiting
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
Led by Li-kun Chen · Updated on 2024-12-11
32
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosed with metastatic or relapsed advanced NSCLC with measurable lesions
- Received at least two prior systemic therapies or unable to tolerate chemotherapy
- Negative for driver gene mutations or treated with relevant targeted drugs but resistant or intolerant
- ECOG performance status score 0-2 with expected survival time of at least 3 months
- Normal major organ function including renal and liver function within specified limits
- Adequate blood counts: ANC ≥ 1.5x10^9/L, platelets ≥ 100x10^9/L, hemoglobin ≥ 90g/L without recent transfusion or EPO dependency
- Normal coagulation function or stable anticoagulation therapy
- Women of childbearing potential agree to use contraception during and for 6 months after study and not breastfeeding; men agree to contraception during and for 6 months after study
- Well-controlled pleural or peritoneal effusions not causing significant respiratory symptoms
- Stable brain metastases symptoms after prior treatment with no intracranial hypertension
You will not qualify if you...
- Previous failure with multi-target anti-angiogenic drugs like anlotinib, cabozantinib, apatinib, lenvatinib; prior bevacizumab allowed if last dose >3 weeks before
- Small cell lung cancer or mixed tumor types
- Positive driver gene mutation not treated with TKIs
- Tumor invading large blood vessels or causing significant bleeding risk
- Other malignant tumors within past 5 years or current
- Planned or recent systemic anti-tumor therapy or radiation therapy within specified timeframes
- Unresolved toxic reactions from prior treatments above grade 1 (except hair loss)
- Conditions affecting oral medication intake
- Pleural effusion or ascites causing significant respiratory symptoms
- Uncontrolled brain metastases within 2 months
- Severe or uncontrolled diseases
- Recent major surgery or trauma within 28 days
- History of serious bleeding or clotting disorders
- Arterial or venous thrombosis within 6 months
- Substance abuse or psychiatric disorders
- Participation in other anti-tumor drug trials within 4 weeks
- Diseases that jeopardize safety or study completion
- Known HIV infection, untreated active hepatitis B, or active hepatitis C infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
L
Li kun Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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