OncoMatch/Clinical Trials/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
Is NCT06728852 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Administration of Vorolanib for advanced non-small cell lung cancer (nsclc).
Treatment: Administration of Vorolanib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy
Previously received at least two systemic therapies, allowing for third-line or higher chemotherapy or unable to tolerate chemotherapy
Cannot have received: multi-target anti-angiogenic drugs (anlotinib, cabozantinib, apatinib, lenvatinib)
Exception: The use of bevacizumab is allowed, but the last administration must be more than 3 weeks before enrollment
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
Lab requirements
Blood counts
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)
Kidney function
creatinine clearance rate ≥ 60 mL/min
Liver function
bilirubin ≤ 1.5× ULN, ALT/AST ≤ 2.5× ULN (for patients with documented liver metastasis, AST and ALT levels ≤ 5× ULN)
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); 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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