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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
SHR-1826
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
RECRUITINGORR assessed by IRC according to RECIST v1.1 s)
Time frame: once every 6 weeks, estimated 2 years
Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1;
Time frame: once every 6 weeks, estimated 2 years
Disease Control Rate (DCR) assessed by the IRC and investigator according to RECIST v1.1;
Time frame: once every 6 weeks, estimated 2 years
Duration of Response (DoR) assessed by the IRC and investigator according to RECIST v1.1;
Time frame: once every 6 weeks, estimated 2 years
Progression-Free Survival (PFS) assessed by the IRC and investigator according to RECIST v1.1;
Time frame: Estimated 2 years
Overall Survival (OS).
Time frame: Estimated 2 years
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