A Phase II Clinical Trial of SHR-1826 for Non-Small Cell Lung Cancer

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.

Inclusion Criteria:

1. Aged 18-75 years
2. ECOG performance status score of 0 or 1;
3. Histopathologically confirmed advanced or metastatic non-small cell lung cancer;
4. Participants must provide archived or fresh tumor tissue;
5. Participants must have experienced disease progression or intolerance after systemic anti-tumor therapy for advanced or metastatic disease;
6. At least one measurable lesion according to RECIST v1.1 criteria;
7. Expected survival ≥3 months;
8. Adequate organ function;

Exclusion Criteria:

1. Central nervous system metastasis or meningeal metastasis with clinical symptoms
2. History of or concurrent other malignancies;
3. Untreated spinal cord compression ;
4. Uncontrolled tumor-related pain;
5. Adverse events (AEs) from prior therapy not recovered to CTCAE Grade ≤1;
6. History of interstitial lung disease;
7. Severe cardiovascular/cerebrovascular diseases;