A Phase II Clinical Study on the Efficacy, Safety, and Pharmacokinetics of SHR-1826 for Injection in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This study is a single-arm, open-label, multicenter phase II clinical trial aimed at evaluating the efficacy, safety, and pharmacokinetics of SHR-1826 in treating locally advanced or metastatic non-small cell lung cancer . The recommended dose of SHR-1826 was administered via intravenous infusion once every 3 weeks (Q3W), with each treatment cycle lasting 21 days until meeting protocol-defined treatment discontinuation criteria.
• Aged 18-75 years
• ECOG performance status score of 0 or 1;
• Histopathologically confirmed advanced or metastatic non-small cell lung cancer;
• Participants must provide archived or fresh tumor tissue;
• Participants must have experienced disease progression or intolerance after systemic anti-tumor therapy for advanced or metastatic disease;
• At least one measurable lesion according to RECIST v1.1 criteria;
• Expected survival ≥3 months;
• Adequate organ function;