NCT04151563撤回1 期
A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapies in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L)1 Immunotherapy
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2021年4月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment
研究概览
简要总结
This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy
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 C: nivolumab + ramucirumab + docetaxel
Experimental
干预措施: nivolumab (Biological)
Arm C: nivolumab + ramucirumab + docetaxel
Experimental
干预措施: docetaxel (Biological)
Arm C: nivolumab + ramucirumab + docetaxel
Experimental
干预措施: ramucirumab (Biological)
Arm A: cabozantinib + nivolumab + ipilimumab
Experimental
干预措施: nivolumab (Biological)
Arm A: cabozantinib + nivolumab + ipilimumab
Experimental
干预措施: ipilimumab (Biological)
Arm A: cabozantinib + nivolumab + ipilimumab
Experimental
干预措施: cabozantinib (Drug)
Arm B: cabozantinib + nivolumab
Experimental
干预措施: nivolumab (Biological)
Arm B: cabozantinib + nivolumab
Experimental
干预措施: cabozantinib (Drug)
Arm D: lucitanib + nivolumab
Experimental
干预措施: nivolumab (Biological)
Arm D: lucitanib + nivolumab
Experimental
干预措施: lucitanib (Drug)
Arm E: nivolumab + docetaxel
Experimental
干预措施: nivolumab (Biological)
Arm E: nivolumab + docetaxel
Experimental
干预措施: docetaxel (Biological)
Arm F: docetaxel
Active Comparator
干预措施: docetaxel (Biological)
结局指标
主要结局
Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment
时间窗: approximately 33 months
次要结局
- Incidence of Adverse Events (AEs)(Up to 5 Years)
- Incidence of Select AEs(Up to 5 Years)
- Duration of Response (DOR) by BICR using RECIST 1.1(approximately 33 months)
- Progression-Free Survival (PFS) by BICR using RECIST 1.1(Up to 5 Years)
- Incidence of Serious Adverse Events (SAEs)(Up to 5 Years)
- Overall Survival (OS)(Up to 5 Years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Phase 2 Study of VELCADE Alone or VELCADE® Plus Docetaxel in Previously Treated Patients With Advanced Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT00051974Millennium Pharmaceuticals, Inc.155
已完成
2 期
Clinical Trial of the Safety and Efficacy of the Addition of Ramucirumab to Nab-paclitaxel in Previously Treated Patients With Advanced Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung CancerNCT02730247Liza Villaruz, MD7
已完成
3 期
Iressa 2nd Line Phase III Study in JapanNon-Small Cell Lung CancerNCT00252707AstraZeneca484
终止
2 期
KN046 in Patients With Advanced Non-small Cell Lung CancerStage IV Non-small Cell Lung CancerNCT03838848Jiangsu Alphamab Biopharmaceuticals Co., Ltd120
招募中
2 期
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL CancerAdvanced Non-squamous Non-small-cell Lung CancerAdvanced Squamous Non-Small Cell Lung CarcinomaMetastatic Non-squamous Non Small Cell Lung CancerMetastatic Squamous Non-Small Cell Lung CarcinomaNon-small Cell Lung Cancer Stage IIINon-small Cell Lung Cancer Stage IVNon-small Cell Lung Cancer RecurrentNon-small Cell Lung CancerNCT06463665Genelux Corporation142