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;
Central nervous system metastasis or meningeal metastasis with clinical symptoms
History of or concurrent other malignancies;
Untreated spinal cord compression ;
Uncontrolled tumor-related pain;
Single group
SHR-1826
DrugSHR-1826
ORR assessed by IRC according to RECIST v1.1 s）
Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1;
Disease Control Rate (DCR) assessed by the IRC and investigator according to RECIST v1.1;
Duration of Response (DoR) assessed by the IRC and investigator according to RECIST v1.1;
Progression-Free Survival (PFS) assessed by the IRC and investigator according to RECIST v1.1;
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