Efficacy and Safety of Vorolanib Monotherapy As Third-line or Later Treatment for Advanced Non-sm… (NCT06728852) | Clinical Trial Compass
RecruitingPhase 2
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
China32 participantsStarted 2024-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Sign the informed consent
. Pathologically or cytologically diagnosed with metastatic/relapsed advanced NSCLC, with measurable lesions (according to RECIST 1.1)
. Previously received at least two systemic therapies, allowing for third-line or higher chemotherapy or unable to tolerate chemotherapy
. Patients with negative results for driver gene testing or patients with positive results who have already received relevant targeted drugs or systemic anti-tumor treatments and are either resistant or unable to tolerate them
. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Expected survival time ≥ 3 months
. Normal major organ function: renal function with creatinine clearance rate ≥ 60 mL/min; liver function with bilirubin ≤ 1.5× upper limit of normal (ULN), ALT/AST ≤ 2.5× ULN (for patients with documented liver metastasis, AST and ALT levels ≤ 5× ULN)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
6-Month Progression-Free Survival (PFS) Rate in Advanced Non-Small Cell Lung Cancer Patients
Timeframe: 6 months from the initiation of treatment
. Good hematological function, defined as an absolute neutrophil count (ANC) ≥ 1.5×10\^9/L, platelet count ≥ 100×10\^9/L, hemoglobin ≥ 90g/L (without blood transfusion or erythropoietin \[EPO\] dependency within the last 7 days)
. Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5× ULN; if the subject is on anticoagulation therapy, PT should be within the intended therapeutic range of the anticoagulant
Exclusion criteria
. Previously failed treatment with multi-target anti-angiogenic drugs, such as anlotinib, cabozantinib, apatinib, lenvatinib, etc. The use of bevacizumab is allowed, but the last administration must be more than 3 weeks before enrollment
. Small cell lung cancer (including small cell carcinoma, non-small cell lung cancer mixed with other types of tumors)
. Testing positive for driver genes but not treated with TKIs
. Tumor invasion of large blood vessels, central squamous cell carcinoma of the lung with cavitation, or non-small cell lung cancer with hemoptysis (\>5ml/day), or where the tumor is likely to invade important blood vessels and cause fatal bleeding during the subsequent study period
. Accompanied by other types of malignant tumors within the past 5 years or currently
. Planning to receive systemic anti-tumor therapy within 4 weeks before enrollment or during the study period, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy (or mitomycin C within 6 weeks before receiving experimental drug therapy); received extended-field radiation therapy (EF-RT) within 4 weeks before enrollment or limited-field radiation therapy within 2 weeks before enrollment with evaluation of lesions recommended
. Unremitting toxic reactions caused by previous treatment, CTCAE grade \>1, excluding hair loss
. Various factors affecting oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, bowel obstruction)