EUCTR2019-000262-38-NL进行中（未招募）1 期
A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer (CheckMate 77T, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 77T)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Participants with suspected or histologically confirmed Stage IIA to IIIB non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
- •- No brain metastasis
- •- Treatment-naive (no prior systemic anti-cancer treatment)
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status of = 1
- •- Ability to provide surgical or biopsy tumor tissue for biomarkers
- •Other protocol defined inclusion/exclusion criteria could apply
- •For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 375
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 375
排除标准
- •- Participants with an active, known or suspected autoimmune disease are excluded
- •- Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection
- •- Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy
- •Other protocol defined inclusion/exclusion criteria could apply
- •For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
研究者
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