Atezolizumab Plus 8 Gy Single-fraction Radiotherapy for Advanced, Oligoprogressive NSCLC After Upfront Chemotherapy and Anti-PD1 Immunotherapy: A Multicentre, Single Arm, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Objective Response Rate
研究概览
简要总结
Multicentre, phase II, open-label, single-arm study evaluating the preliminary efficacy, safety and tolerability of atezolizumab in association with palliative radiotherapy in adult patients diagnosed with advanced (stage IV) NSCLC, irrespective of PD-L1 status, and who have oligoprogressed to both immunotherapy with an anti PD-1 agent (e.g., pembrolizumab or nivolumab) and 1 line of chemotherapy.
详细描述
Atezolizumab will be administered at a fixed dose of 1,200 mg by intravenous infusion every 21 days on an outpatient basis according to the its approved prescribing information. Palliative radiation therapy will be delivered concomitant to the 2nd dose of atezolizumab as a single fraction of 8 Gy to all eligible metastatic and primary sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Atezolizumab
Atezolizumab will be administered at a fixed dose of 1,200 mg by intravenous infusion every 21 days on an outpatient basis until progression, intolerance or loss of clinical benefit, according to the its approved prescribing information. Palliative radiation therapy will be delivered concomitant to the 2nd dose of atezolizumab as a single fraction of 8 Gy
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 3 months
Percentage of patients with a complete response or partial response
次要结局
- Progression Free-Survival(12 months)
- Overall Survival(12 months)