Efficacy and Safety of Ivonescimab Monotherapy as First-Line Treatment for PD-L1-Positive, Driver Gene-Negative, Locally Advanced or Metastatic NSCLC: A Multicenter, Prospective, Real-World Cohort Study

Registry record from ClinicalTrials.gov (NCT07696832). This is a study registration, not published results. Lead sponsor: Guangdong Association of Clinical Trials. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 265 participants (ESTIMATED). Conditions: Patients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLC, EGFR Mutation-negative and ALK Rearrangement-negative, Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 0 to 2, No Prior Systemic Therapy Received for the Advanced or Metastatic Disease, PD-L1 Positive, as Determined by a Validated Assay. Interventions: DRUG: Ivonescimab Injection. Primary outcome measures: median rwPFS , From date of first dose to date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 36 months.. Brief summary: The treatment decisions, assessment schedule, and study procedures in this research will adhere to the routine clinical practice of each participating center. The specifics are as follows: Treatment Decisions: Treatment will be administered in accordance with the officially approved drug label for Ivonescimab by the National Medical Products Administration (NMPA) and the latest domestic and international guidelines. Eligible patients meeting the inclusion criteria will receive first-line Ivonescimab monotherapy until disease progression or unacceptable toxicity occurs. The recommended dosage of Ivonescimab is 20 mg/kg administered intravenously every 3 weeks. Each infusion should be completed over 60 minutes (± 10 minutes). For patients who cannot tolerate the 60-minute (± 10 minutes) infusion, the duration may be extended to a maximum of 120 minutes (± 10 minutes). Dosing may be interrupted or permanently discontinued based on individual patient safety and tolerability; however, dose increases or reductions are not recommended. Dose modification and management of adverse events will follow the drug label and relevant guidelines. Any other concomitant supportive care or medications during the study period should be based on a comprehensive patient assessment, excluding contraindications explicitly stated in the label or guidelines, and administered according to the routine clinical practice of each center. Assessment Plan: The timing, items, and frequency of all assessments, including tumor imaging evaluations and laboratory tests, will follow the routine clinical practice of each participating center. Study Procedures: This study does not mandate protocol-defined study visits. A suggested visit schedule is provided solely to facilitate unified data collection and management. Investigators will prospectively and continuously collect clinical data for all patients who provide signed informed consent and meet the eligibility criteria via an Electronic Data Capture (EDC) system until a study endpoint event occurs or the study concludes.