Perioperative Immunotherapy for Early-stage Non-small-cell Lung Cancer: a Randomised, Multicentre, Open-label, Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 200
- 主要终点
- Disease-free survival
研究概览
简要总结
This trial is a randomized, multicenter, open label phase II clinical study. The main objective is to evaluate the efficacy of three perioperative immunotherapy modalities (atezolizumab adjuvant therapy, nivolumab neoadjuvant therapy, pembrolizumab neoadjuvant+adjuvant therapy) in early-stage resectable NSCLC patients. The enrolled patients are randomly assigned in a 1:1:1 ratio to receive relevant treatment in the three perioperative immunotherapy groups mentioned above, and undergoing short-term pathological efficacy evaluation and long-term prognosis follow-up after surgery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who sign the informed consent form and are willing to complete the study according to the plan;
- •Aged from 18 to 80 years old;
- •ECOG equals 0 or 1;
- •Not receiving lung cancer surgery before;
- •Resectable cIB-IIIA tumors;
- •Not receiving chemotherapy or radiotherapy before.
排除标准
- •Not cIB-IIIA tumors;
- •Nodules not suitable for resection;
- •Not lung adenocarcinoma diagnosed cytologically or pathologically;
- •Receiving lung cancer surgery before;
- •Receiving radiotherapy or chemotherapy.
研究组 & 干预措施
Pembrolizumab
干预措施: Pembrolizumab (Drug)
Atezolizumab
干预措施: Atezolizumab (Drug)
Nivolumab
干预措施: Nivolumab (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 2 years
the time from randomisation to the date of first recurrence, occurrence of new primary lung cancer, or death from any cause
次要结局
- Major pathological response(2 years)
- Overall survival(2 years)
研究者
Haiquan Chen
Director in the Department of Thoracic Surgery, FUSCC
Fudan University