EUCTR2012-004502-93-ES进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,250
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 750
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
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
相似试验
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 CancerStage IV or Recurrent Non-Small Cell Lung CancerMedDRA version: 21.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10029515 Term: Non-small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-004502-93-PLBristol-Myers Squibb International Corporation1,571
进行中（未招募）
不适用
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 CancerStage IV or Recurrent Non-Small Cell Lung CancerMedDRA version: 16.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-004502-93-ITBristol-Myers Squibb International Corporation1,250
已完成
3 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 CancerNon-small cell lung cancer (NSCLC)10038666NL-OMON44891Bristol-Myers Squibb21
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 CancerStage IV or Recurrent Non-Small Cell Lung CancerMedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-004502-93-DEBristol-Myers Squibb International Corporation1,571
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 CancerStage IV or Recurrent Non-Small Cell Lung CancerMedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-004502-93-BEBristol-Myers Squibb International Corporation1,571