This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer.
Voluntary participation and written informed consent.
18-75 years old, no gender limitation.
Newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.
Confirmed tumor PD-L1 status prior to randomization.
Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
Previous or co-existing malignancies；
Have Active or prior documented autoimmune or inflammatory disorders;
Parallel
SHR-8068，adebelizumab and platinum-based chemotherapy
DrugSHR-8068，adebelizumab and platinum-based chemotherapy
tislelizumab, and platinum-based chemotherapy
Drugtislelizumab, and platinum-based chemotherapy
Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR]
PFS (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]) by BICR was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression)
OS
OS was defined as the time from the date of randomization until death due to any cause.
PFS by the investigator
PFS (per RECIST 1.1) by the investigator was defined as time from date of randomization until date of objective disease or death (by any cause in the absence of progression)
Objective Response Rate (ORR)
ORR (per RECIST 1.1) by BICR or the investigator was defined as the percentage of patients with at least one visit response of complete response (CR) or partial response (PR).
Duration of Response (DoR)
DoR (per RECIST 1.1) by BICR or the investigator was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.
Incidence and Severity of Adverse Events (AEs)
Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 60 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent.
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