A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 18
- 主要终点
- ORR
研究概览
简要总结
This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.
详细描述
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+/C797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and efficacy of WSD0922-FU in patients with advanced NSCLC whose cancers have progressed with or without brain metastasis following a first-line Osimertinib treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose level A selected from Phase I study
BID
干预措施: WSD0922-FU Tablets, Dose level A (Drug)
Dose level B selected from Phase I study
BID
干预措施: WSD0922-FU Tablets, Dose level B (Drug)
结局指标
主要结局
ORR
时间窗: every 8 weeks, up to 1 year
proportion of patients with a best overall response of complete response or partial response
次要结局
- Duration of Response (DoR)(every 8 weeks, up to 1 year)
- PFS(every 8 weeks, up to 1 year)
- Disease Control Rate (DCR)(every 8 weeks, up to 1 year)
- Overall Survival (OS)(24 months)
- EORTC QLQ-C30 (HRQoL)(up to 24 months)
- EORTC QLQ-LC13 (HRQoL)(up to 24 months)
- PRO CTCAE (HRQoL)(up to 24 months)
