JPRN-jRCT2080223860已完成2 期
Phase II study of Trastuzumab Deruxtecan (DS-8201a) in subjects with non-small cell lung cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Age >= 20 years old.
- •2. Pathologically documented unresectable and/or metastatic non-squamous NSCLC.
- •3. Has relapsed from or is refractory to standard treatment or for which no standard treatment is available.
- •4. For Cohort 1 and Cohort 1a only: HER2-overexpression (IHC 2+ or 3+) status must be assessed and confirmed from an archival tumor tissue sample.
- •5. For Cohort 2 only: Documented any known activating HER2 mutation from an archival tumor tissue sample.
- •6. Presence of at least 1 measurable lesion assessed by the investigator based on RECIST ver. 1.1.
- •7. Is willing and able to provide an adequate archival tumor tissue sample.
- •8. Is willing to undergo a tissue biopsy, after the completion of the most recent treatment regimen.
排除标准
- •1. Was previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors.
- •2. For Cohort 1 and Cohort 1a only: Has known HER2 mutation.
- •3. Has an uncontrolled or significant cardiovascular disease
- •4. Has a medical history of clinically significant lung disease.
研究者
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