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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

NCT07696832 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 265

Last updated 2026-07-10

No results posted yet for this study

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.

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

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 enrolled in the study will receive first-line Ivonescimab monotherapy until disease progression or unacceptable toxicity occurs. The recommended dosage of Ivonescimab is 20 mg/kg administered via intravenous infusion every 3 weeks. Each infusion should be completed over 60 minutes (± 10 minutes). For patients intolerant to 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 adverse event management will follow the instructions in the drug label and relevant guidelines. Any concomitant supportive treatments or medications administered during the s

Sponsors & Collaborators

  • Guangdong Association of Clinical Trials

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2027-05-15
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07696832 on ClinicalTrials.gov