Disease Registry on Patients With Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 126
- 主要终点
- Best Overall Response (BOR)
研究概览
简要总结
The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time.
The registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14(METex14) participants treated with systemic therapy.
详细描述
This is a disease registry, which is an organized system using non-interventional methods to collect data on a patient population defined by a particular disease, exposure, or condition, and which is followed over time. Non-interventional means that after participants enrollment, participants will be treated according to the routine clinical treatment decision by the physician. The registry will not impose any treatment or procedure for participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who signed ICF
- •Participants with advanced stage (stages IIIB-IV) NSCLC (all histologies) and Confirmed METex14 skipping alterations (by valid assay)
- •Participants who are starting or are already being treated with systemic therapy
排除标准
- •Participants who are enrolled in a clinical trial
研究组 & 干预措施
Advanced Non-small Cell Lung Cancer with METex14 skipping alterations
Participants diagnosed with advanced NSCLC and who receive available therapies in routine clinical practice setting will be part of this registry. Data will be collected routinely from the point of enrollment of a participants into the registry until death, loss to follow-up (drop-out), subsequent enrollment into a clinical trial, or end of data collection period for the registry.
结局指标
主要结局
Best Overall Response (BOR)
时间窗: Through study completion, up to approximately 4.9 years
Overall Survival (OS)
时间窗: Through study completion, up to approximately 4.9 years
Tumor Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
时间窗: Up to approximately 4.9 years
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 4.9 years
Number of Participants with Adverse Reactions (ARs)
时间窗: Up to approximately 4.9 years
次要结局
未报告次要终点