Prospective, Multi-cohort, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Befotertinib in EGFR-positive Non-classical Mutant Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) assessed by RECIST 1.1.
研究概览
简要总结
This is a prospective, multi-cohort, single-arm Phase II clinical trial evaluating the efficacy and safety of befotertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR non-classical mutations.
The study comprises two independent cohorts:
Cohort 1: Patients with EGFR uncommon mutations (G719X, L861Q, or S768I). Cohort 2: Patients with EGFR exon 20 insertion mutation
Primary endpoint: Objective response rate (ORR) assessed by RECIST 1.1. Secondary endpoints: Disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety profile (CTCAE v4.03).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age ≥18 years, ECOG performance status 0-2
- •Histologically confirmed locally advanced/metastatic NSCLC
- •Documented EGFR mutations: Cohort 1 (G719X/L861Q/S768I) or Cohort 2 (exon 20 insertion)
- •No prior EGFR-TKI therapy
- •Progression or intolerance to ≥1 line of platinum-based chemotherapy -≥1 measurable lesion per RECIST 1.1
排除标准
- •Previous EGFR-TKI treatment
- •Active CNS metastases (asymptomatic patients with stable lesions allowed)
- •Severe cardiovascular disease (e.g., QTc ≥450 ms, myocardial infarction within 6 months)
- •Active HBV/HCV/HIV infection
- •Pregnancy or lactation
研究组 & 干预措施
G719X, L861Q, or S768I)
Patients with EGFR uncommon mutations (G719X, L861Q, or S768I)
干预措施: befotertinib (Drug)
exon 20 insertion
Patients with EGFR exon 20 insertion mutations
干预措施: befotertinib (Drug)
结局指标
主要结局
Objective response rate (ORR) assessed by RECIST 1.1.
时间窗: From enrollment until treatment discontinuation (up to 24 months)
次要结局
- progression-free survival (PFS)(From first dose to disease progression or death (assessed up to 36 months))
- Disease control rate (DCR)(From enrollment until treatment discontinuation (up to 24 months))
- duration of response (DoR)(From the first documented response to disease progression or death, whichever occurs first, assessed up to 36 months.)
- overall survival（OS）(From enrollment until death from any cause, assessed up to 60 months. Survivors will be censored at the last follow-up)