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临床试验/NCT06868485
NCT06868485招募中2 期

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

Wayshine Biopharm, Inc.18 个研究点 分布在 3 个国家目标入组 40 人开始时间: 2025年8月18日最近更新:
干预措施
相关药物

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

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

Experimental

BID

干预措施: WSD0922-FU Tablets, Dose level A (Drug)

Dose level B selected from Phase I study

Experimental

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)

研究者

发起方
Wayshine Biopharm, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (18)

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