EUCTR2012-004502-93-CZ进行中(未招募)1 期
An Open-Label, Randomized, Phase 3 Trial of Nivolumab versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer - CheckMate 026: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 026
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
- 1,571
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
- •ECOG PS = 1
- •Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
- •Measurable disease by CT or MRI per RECIST 1.1 criteria
- •PD-L1+ on immunohistochemistry testing performed by central lab
- •Men and women, ages = 18 years of age
- •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 943
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 628
排除标准
- •Known EFGR mutations which are sensitive to available targeted inhibitor therapy
- •Known ALK translocations
- •Untreated CNS metastases
- •Previous malignancies
- •Active, known or suspected autoimmune disease
研究者
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