NCT07008287招募中不适用
A Multicenter, Non-interventional, Observational Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) with brain metastases. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Taletrectinib will be administered according to clinical practice and data on treatment patterns, clinical outcomes, and safety will be collected during routine evaluations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients must meet all of the following criteria to be eligible for enrollment into the study:
- •Age ≥ 18 years.
- •Histologically or cytologically metastatic NSCLC (UICC/AJCC TNM Staging System, 9th Edition, Stage Ⅳ).
- •At least one measurable target tumor lesion as accessed by RECIST v1.1 criteria.
- •Radiographically confirmed brain metastasis(es) , with stable CNS symptoms within 2 weeks prior to enrollment.
- •Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).
- •Considered by the investigator to be candidates for Taletrectinib treatment ; OR Patients with ≤6 months of prior Taletrectinib exposure enrolled retrospectively. (Note: For retrospective patients deceased before enrollment, waiver of informed consent is required. Patients who initiated and discontinued treatment within 6 months prior to signing informed consent are eligible).
- •Signed Informed Consent.
排除标准
- •Patient presenting with any of the following criteria will not be included in the study：
- •Patients with driver gene mutations/alterations that have approved targeted therapies , including but not limited to EGFR, ALK, RET, etc.
- •Currently participating in other interventional clinical trials or having received investigational drug treatment within 4 weeks prior to enrollment .
- •Pregnancy or breastfeeding.
- •Patients with uncontrolled co-morbidities who are assessed by the investigator not to receive targeted therapy.
- •Other conditions that are assessed by the investigator to be unsuitable for enrollment in this study.
研究组 & 干预措施
cohort 1
ROS1 fusion positive NSCLC patients with brain metastases who received taletrecitnib
干预措施: Taletrectinib (Drug)
结局指标
主要结局
ORR
时间窗: 6 months
Objective response rate
iORR
时间窗: 6 months
Intracranial objective response rate
次要结局
- PFS(25 months)
- DoR(25 months)
- DCR(6 months)
- OS(51 months)
- iDoR(6 months)
- iPFS(25 months)
- iDCR(6 months)
- Adverse events(25 months)
研究者
研究点 (1)
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