NCT06140836进行中（未招募）3 期
Randomized, Open-label, Multicenter, Phase 3 Trial 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)
Bristol-Myers Squibb122 个研究点 分布在 11 个国家目标入组 190 人开始时间: 2023年12月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
- 试验地点
- 122
- 主要终点
- Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).
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
- •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 ≤ 2
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)
- •Note: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A
Experimental
干预措施: Repotrectinib (Drug)
Arm B
Active Comparator
干预措施: Crizotinib (Drug)
结局指标
主要结局
Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Up to approximately 41 months
次要结局
- Overall Survival (OS)(Up to approximately 41 months)
- Overall Response Rate (ORR) as per BICR according to RECIST v1.1(Up to approximately 41 months)
- ORR as per Investigator according to RECIST v1.1(Up to approximately 41 months)
- Duration of Response (DOR) as per BICR according to RECIST v1.1(Up to approximately 41 months)
- DOR as per Investigator according to RECIST v1.1(Up to approximately 41 months)
- Time to Response (TTR) as per BICR according to RECIST v1.1(Up to approximately 41 months)
- TTR as per Investigator according to RECIST v1.1(Up to approximately 41 months)
- PFS as per Investigator according to RECIST v1.1(Up to approximately 41 months)
- Time to intracranial progressions as per BICR according to RECIST v1.1(Up to approximately 41 months)
- Number of participants with Adverse Events (AEs), Serious AEs (SAEs), AEs leading to study intervention discontinuation, and drug-related AEs(Up to 30 days after last dose)
- Number of deaths(Up to 30 days after last dose)
- Number of participants without at least a 3-point change in the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) total score(Up to 30 days after last dose)
研究者
研究点 (122)
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