A Phase 1b Clinical Study of NXP900 in Combination With Osimertinib in Subjects With Advanced, EGFRMut+ Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
研究概览
简要总结
This is a multi-center, open label, Phase 1b study of NXP900 in combination with osimertinib in subjects with advanced, progressing, EGFR-mutated non-small cell lung cancer (NSCLC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Provide written informed consent.
- •18 years old or older.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Unresectable, metastatic or locally advanced EGFR-mutated NSCLC.
- •Prior treatment with osimertinib as first or second line, as single agent or in combination with chemotherapy, in the metastatic or locally advanced setting.
排除标准
- •Subject's cancer has a known oncogenic driver alteration other than EGFR.
- •Known EGFR mutations that cause resistance to osimertinib
- •Known human epidermal growth factor receptor 2 (HER2) overexpression
- •Any contraindications to treatment with osimertinib
研究组 & 干预措施
Dose Exploration (Part 1)
Escalating doses of NXP900 given with osimertinib
干预措施: Osimertinib (Drug)
Dose Exploration (Part 1)
Escalating doses of NXP900 given with osimertinib
干预措施: NXP900 (Drug)
结局指标
主要结局
Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
时间窗: Up to 30 days post treatment
Duration of Response (DoR)
时间窗: Up to approximately 12 months
Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
Objective response rate (ORR)
时间窗: Up to approximately 12 months
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Disease Control Rate (DCR)
时间窗: Up to approximately 12 months
The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).
次要结局
未报告次要终点