A Randomized, Open-label, Controlled, Multicenter Phase III Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy Versus Tislelizumab Combined With Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Eastern Cooperative Oncology Group (ECOG) score: 0-1
- •With a life expectancy ≥ 3 months.
- •At least one measurable lesion according to RECIST v1.1.
排除标准
- •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;
- •Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
- •Have an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis.
研究组 & 干预措施
SHR-8068，adebelizumab and platinum-based chemotherapy
干预措施: SHR-8068，adebelizumab and platinum-based chemotherapy (Drug)
tislelizumab, and platinum-based chemotherapy
干预措施: tislelizumab, and platinum-based chemotherapy (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR]
时间窗: Approximately 32 months.
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
时间窗: Approximately 64 months.
OS was defined as the time from the date of randomization until death due to any cause.
次要结局
- PFS by the investigator(Approximately 32 months.)
- Objective Response Rate (ORR)(Approximately 32 months.)
- Duration of Response (DoR)(Approximately 32 month)
- Incidence and Severity of Adverse Events (AEs)(Approximately 64 months.)
- Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ C30-Lung Cancer Module 13 (QLQ-LC13)(Approximately 64 months.)