2022-501360-18-00已完成3 期
Randomized, Open-Label, Phase 3 Trial of Nivolumab plus Ipilimumab or Nivolumab plus Platinum-Doublet Chemotherapy versus Platinum-Doublet Chemotherapy in Early Stage NSCLC
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 16
- 主要终点
- Event-Free Survival
研究概览
简要总结
-To compare the event-free survival (EFS) by blinded independent central review (BICR) in participants receiving nivolumab plus platinum doublet chemotherapy vs participants receiving platinum doublet chemotherapy in operable stage IB (>= 4 cm), II, or resectable IIIA (N2) NSCLC. -To compare the pathologic complete response (pCR) rate in participants receiving nivolumab plus platinum doublet chemotherapy vs participants receiving platinum doublet chemotherapy in operable stage IB (>= 4cm), II, or resectable IIIA (N2) NSCLC
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Early stage (IB - IIIA), operable non-small cell lung cancer, confirmed in tissue.
- •Lung function capacity capable of tolerating the proposed lung surgery
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-
- •Available tissue of primary lung tumor.
排除标准
- •Presence of locally advanced, inoperable or metastatic disease.
- •Participants with active, known or suspected autoimmune disease.
- •Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).
结局指标
主要结局
Event-Free Survival
Event-Free Survival
Pathological Complete Response
Pathological Complete Response
次要结局
- Overall survival (OS)
- Major pathological response (MPR)
- Time to Death or Distant Metastases (TTDM)
研究者
GSM-CT
Scientific
Bristol-Myers Squibb International Corporation
研究点 (16)
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