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
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.
• 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)
• 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
• Female patients of childbearing potential must agree to use contraception (e.g., intrauterine device, contraceptives, or condoms) during the study and for 6 months after the study ends; must not be breastfeeding and must have a negative serum or urine pregnancy test within 7 days before enrollment. Male patients must agree to use contraception during the study and for 6 months after the study ends
⁃ Patients with well-controlled pleural or peritoneal effusions that do not cause grade 2 or higher respiratory syndrome (≥ CTCAE grade 2) can be included
⁃ Patients without clinical symptoms of intracranial hypertension caused by brain metastases or with brain metastasis symptoms that are stable after prior treatment (radiation therapy or surgery) of brain or meningeal metastasis (usually requiring more than 4 weeks post-radiation therapy)