International Real-World Study of MET Overexpression in Patients With Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 579
- 试验地点
- 19
- 主要终点
- Presence of Mesenchymal Epithelial Transition (MET) protein overexpression (OE)
研究概览
简要总结
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%-85% of lung cancers cases of which 60% are non-squamous (NSQ). This study will evaluate the prevalence of mesenchymal epithelial transition (MET) overexpression (OE) in adult participants with advanced or metastatic NSQ NSCLC.
Archived tissue biopsies will be tested for MET OE and data from approximately 500 participants will be collected. No participants will be enrolled in this study.
Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 15 months.
There is no additional burden for participants in this trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Previously consented and/or prospective collection of consent for research use of banked biological materials and clinical data.
- •Confirmed advanced and/or metastatic non-squamous (NSQ) non-small cell lung cancer (NSCLC).
- •Has formalin-fixed paraffin-embedded (FFPE) tissue collected since 2019.
排除标准
- •Specimens collected before
- •Insufficient specimen tissue for testing.
- •Insufficient specimen quality (e.g., not 4-5 µm in thickness) which precludes testing.
- •Adenosquamous and sarcomatous histologies of NSCLC.
结局指标
主要结局
Presence of Mesenchymal Epithelial Transition (MET) protein overexpression (OE)
时间窗: Up to 15 Months
OE is defined as: positive: \>= 25% of tumor cells with 3+ staining intensity, or negative: \< 25% of tumor cells with 3+ staining intensity. High overexpression (OE high) is defined as: positive: \>= 50% of tumor cells with 3+ staining intensity negative: \< 50% of tumor cells with 3+ staining intensity. These are determined by an immunohistochemistry (IHC) performed by the local laboratory.
次要结局
未报告次要终点