A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 537
- 试验地点
- 7
- 主要终点
- Major pathological response rate (MPR)
研究概览
简要总结
This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or placebo and monitoring.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Have previously untreated, pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC. Staging should be based on the 8th edition of the AJCC/UICC staging system
- •Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
- •Adequate tumor tissue sample blocks for central programmed death-ligand 1 (PD-L1) testing
- •Measurable disease as defined by RECIST v1.1
- •Adequate organ function
- •Women of childbearing age without sterilizing or male, must agree to use contraception or practice abstinence at least 180 days after the last dose of study treatment
排除标准
- •Any previous systematic anti-cancer therapy for lung cancer
- •With active, known or suspected autoimmune disease of autoimmune disease
- •Malignancies other than NSCLC within 5 years prior to randomization
- •Has or suspected has a history of pneumonitis /interstitial lung disease or any serve lung diseases which will influence the examination of lung function
- •Significant history of cardiovascular and cerebrovascular disease
- •Significant haemorrhagic disease
- •Has an arteriovenous thrombotic events
- •Has a known history of human immunodeficiency virus (HIV) infection
- •Has a known active Hepatitis B or Hepatitis C
- •Allergic to monoclonal antibodies or other protein drugs
- •Allergic to the intervention regimens
- •Pregnant or lactating women
- •Has known psychiatric or substance abuse disorders
- •Confirmed COVID-19 infection or suspected COVID-19 infection or close contact with a person with known or suspected COVID-19 infection.
研究组 & 干预措施
Treatment group A
Neoadjuvant setting: Drug: SHR-1316 and carboplatin and Paclitaxel (Albumin Bound) 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles
干预措施: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin (Drug)
Treatment group B
Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles
干预措施: SHR-1316、Chemotherapeutic (Drug)
Treatment group C
Neoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles
干预措施: Placebo、Chemotherapeutic (Drug)
结局指标
主要结局
Major pathological response rate (MPR)
时间窗: At time of surgery
Event free survival (EFS)
时间窗: Approximately 66 months
次要结局
- Disease-Free Survival (DFS)(Approximately 66 months)
- Pathology complete response (pCR)(At time of surgery)
- Overall survival (OS)(Approximately 96 months)
- Objective response rate (ORR)(prior to surgery)