AUGTYRO™ (Repotrectinib) Post-Marketing Surveillance in Korean Patients With Locally Advanced or Metastatic Ros1-Positive NSCLC or Solid Tumors Harboring a NTRK Gene Fusion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants experiencing adverse events
研究概览
简要总结
This observational study evaluates the real-world safety and effectiveness of repotrectinib in Korean participants with locally advanced or metastatic ROS1-positive non-small cell lung cancer or solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions. Participants receiving repotrectinib in routine clinical practice will be followed for up to 12 months or until the end of the 2-year surveillance period, whichever occurs first.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged ≥19 years with histologically OR cytologically confirmed locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
- •Participants aged ≥12 years with solid tumors harboring Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusions
- •Documented ROS1 or NTRK 1-3 gene fusion by validated local testing
- •Written informed consent
排除标准
- •Treatment with repotrectinib for indications not approved in Korea
- •Treatment with repotrectinib at dosages not approved in Korea
- •Contraindication to repotrectinib according to MFDS prescribing information
研究组 & 干预措施
NTRK Gene Fusion Solid Tumor Cohort
Participants ≥12 years with solid tumors harboring NTRK gene fusions that are locally advanced, metastatic, or likely to cause severe morbidity if surgically resected
干预措施: Repotrectinib (Drug)
ROS1-Positive NSCLC Cohort
Participants ≥19 years with histologically or cytologically confirmed locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
干预措施: Repotrectinib (Drug)
结局指标
主要结局
Number of participants experiencing adverse events
时间窗: Up to 12 months
Adverse events include: adverse drug reaction (ADR), serious adverse event (SAE), serious adverse drug reaction (SADR), unexpected adverse event (AE), unexpected ADR, unexpected SAE or SADR and adverse events of special interest (AESI)
次要结局
- Number of participants achieving objective tumor response according to RECIST version 1.1(Up to 12 months)