jRCT2021230046进行中（未招募）不适用
Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants with Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naive ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)
Bristol-Myers Squibb0 个研究点目标入组 190 人开始时间: 2024年2月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC
- •Participant has a ROS1 gene rearrangement/fusion as detected by a local test.
- •At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator.
- •Participants must not be exposed previously with TKIs that demonstrated activities in ROS1-positive NSCLC
- •Up to 1 prior line of systemic treatment for NSCLC is permitted
- •ECOG Performance Status is 2 or less
排除标准
- •Symptomatic brain metastases or symptomatic leptomeningeal involvement.
- •History of previous cancer requiring therapy within the previous 2 years, except for NSCLC under study, squamous cell or basal-cell carcinoma of the skin, or any in situ
- •carcinoma that has been completely resected.
- •Known tumor targetable co-mutations or rearrangements
- •Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment)
结局指标
主要结局
-
PFS per BICR, according to RECIST v1.1 [Time Frame: Up to 64 months]
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
3 期
A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)Carcinoma, Non-Small-Cell LungNCT06140836Bristol-Myers Squibb190
已完成
1 期
A phase I/II study of crizotinib for recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and phase I study of this drug for recurrent or refractory neuroblastomaJPRN-UMIN000028075St. Marianna University School of Medicine Hospital National Center for Child Health and Development Nagoya Medical Center Kyushu University Hospital23
招募中
不适用
A phase IB study of crizotinib in pediatric malignancieschildren, cancer, pediatric malignancies, ALK positive tumors, ROS1 positive tumors, MET positive tumorskinderen, kanker, pediatrische maligniteiten, tumoren positief voor ALK, ROS1, MET afwijkingenNL-OMON24969niversity Medical Center Erasmus Medical Center Rotterdam The Netherlands82
已完成
2 期
Efficacy of crizotinib in alectinib-refractory patients with NSCLC harboring EML4-ALK; phaseII trial (OLCSG1405)on-small cell lung cancer harboring EML4-ALKJPRN-UMIN000015984Okayama Lung Cancer Study Group9
终止
1 期
A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid TumorsKRAS Mutation-Related TumorsMetastatic Solid TumorAdvanced Solid TumorNCT05071183Turning Point Therapeutics, Inc.9