A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
The purpose of this study is to determine if nivolumab added to the standard of care therapy (SOC) given after surgery is more effective than SOC alone in prolonging disease free survival in NSCLC participants with minimal residual disease detected 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 —（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
Arm A
Nivolumab + SOC (chemotherapy in eligible participants or observation)
干预措施: Observation (Other)
Arm B
SOC (chemotherapy in eligible participants or observation)
干预措施: Observation (Other)
Arm A
Nivolumab + SOC (chemotherapy in eligible participants or observation)
干预措施: Nivolumab (Biological)
Arm A
Nivolumab + SOC (chemotherapy in eligible participants or observation)
干预措施: Vinorelbine (Drug)
Arm A
Nivolumab + SOC (chemotherapy in eligible participants or observation)
干预措施: Gemcitabine (Drug)
Arm A
Nivolumab + SOC (chemotherapy in eligible participants or observation)
干预措施: Docetaxel (Drug)
Arm A
Nivolumab + SOC (chemotherapy in eligible participants or observation)
干预措施: Pemetrexed (Drug)
Arm A
Nivolumab + SOC (chemotherapy in eligible participants or observation)
干预措施: Cisplatin (Drug)
Arm A
Nivolumab + SOC (chemotherapy in eligible participants or observation)
干预措施: Carboplatin (Drug)
Arm A
Nivolumab + SOC (chemotherapy in eligible participants or observation)
干预措施: Paclitaxel (Drug)
Arm B
SOC (chemotherapy in eligible participants or observation)
干预措施: Vinorelbine (Drug)
Arm B
SOC (chemotherapy in eligible participants or observation)
干预措施: Gemcitabine (Drug)
Arm B
SOC (chemotherapy in eligible participants or observation)
干预措施: Docetaxel (Drug)
Arm B
SOC (chemotherapy in eligible participants or observation)
干预措施: Pemetrexed (Drug)
Arm B
SOC (chemotherapy in eligible participants or observation)
干预措施: Cisplatin (Drug)
Arm B
SOC (chemotherapy in eligible participants or observation)
干预措施: Carboplatin (Drug)
Arm B
SOC (chemotherapy in eligible participants or observation)
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: Approximately 24 months
次要结局
- Incidence of serious adverse events (SAEs)(Approximately 36 months)
- ctDNA duration of response (DOR)(Approximately 36 months)
- ctDNA time to response (TTR)(Approximately 36 months)
- Incidence of adverse events (AEs)(Approximately 36 months)
- Circulating tumor DNA (ctDNA) response rate(Approximately 36 months)