HER3 Prevalence in Archival Tissue and Associated Real World (RW) Data From Non-Small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- HER3 Expression Prevalence Estimate for the NSCLC Population, Overall
研究概览
简要总结
There is currently a lack of published HER3 expression prevalence data among non-small cell lung cancer (NSCLC) patients. The estimation of HER3 expression prevalence in this population using archival tissue samples and the assessment of associated patient characteristics in real world (RW) data will ultimately inform clinical strategy and increase awareness among health care providers (HCPs) and the greater medical community to improve patient care.
详细描述
The purpose of this study is to use archival tissue samples and RW data to generate HER3 expression prevalence data within the NSCLC population and by patient characteristics (e.g., ethnicity, histology, smoking status, age, prior treatment, etc.).
The primary objective of the study will analyze and assess archival tissue specimens and associated RW data to:
- Increase the understanding of HER3 expression in NSCLC among HCPs and the medical community
- Generate evidence to support future clinical strategies in this area
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
- •Age ≥18 years in US
- •Histologically or cytologically documented advanced or metastatic NSCLC
- •At least one sample available and evaluable for HER3 expression
- •Additional population-specific inclusion criteria:
- •For Cohort 1:
- •Tissue sample collected on or after January 1, 2013
- •For Cohort 2:
- •EGFRm NSCLC previously treated with a 3rd generation EGFR TKI
- •2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment, where the treatment is a 3rd generation TKI (defined as Osimertinib, Aumolertinib [formerly Almonertinib])
- •For Cohort 3:
- •ALK+ NSCLC
- •2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment, where the treatment is a TKI
- •For Cohort 4:
- •NSCLC harboring a KRAS p.G12C mutation or EGFR exon 20 insertion
- •2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment
排除标准
- •Prior treatment with an anti-HER3 antibody or topoisomerase I inhibitor (single-agent or combination)
- •Prior treatment with an antibody drug conjugate (ADC) that contains a topoisomerase I inhibitor
- •Previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease
结局指标
主要结局
HER3 Expression Prevalence Estimate for the NSCLC Population, Overall
时间窗: 6 months
The overall HER3 expression prevalence estimate will be reported.
HER3 Expression Prevalence Estimate for the NSCLC Population, by Subgroup
时间窗: 6 months
HER3 expression prevalence estimate will be reported by subgroup, including age, gender, smoking status, epidermal growth factor receptor (EGFR) status, AGA status, ethnicity, and location of biopsy.
HER3 Expression Prevalence Estimate for the NSCLC Population Before and After Treatment, by Patient Subpopulation
时间窗: 6 months
HER3 expression prevalence estimate before and after treatment will be reported by patient subpopulation (EGFRm NSCLC previously treated with a 3rd generation EGFR TKI, ALK+ NSCLC, NSCLC harboring a KRAS p.G12C mutation or EGFR exon 20 insertion).
次要结局
未报告次要终点