NCT07298148
尚未招募
2 期
A Multicenter, Prospective, Phase II, Single-Arm Study of Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating Stable Disease After 8 Week Induction With Firmonertinib 80 mg
Peking University Cancer Hospital & Institute0 个研究点目标入组 28 人开始时间: 2026年1月1日最近更新:
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Peking University Cancer Hospital & Institute
- 入组人数
- 28
- 主要终点
- Objective Response Rate (ORR)
概览
简要总结
This study evaluates the efficacy and safety of Firmonertinib 160 mg once daily in patients with EGFR-mutant, advanced NSCLC who achieve stable disease after first-line Firmonertinib 80 mg for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years.
- •ECOG performance status 0-1; life expectancy ≥3 months.
- •Histologically/cytologically confirmed advanced/metastatic non-squamous NSCLC unsuitable for curative therapy.
- •Documented EGFR 19del or L858R mutation.
- •No prior systemic therapy for advanced disease.
- •Stable disease after 8 weeks of Firmonertinib 80 mg daily.
- •more than 1 measurable lesion per RECIST v1.
- •Adequate hematologic, renal, hepatic, and coagulation function.
- •Signed written informed consent.
排除标准
- •Hypersensitivity to Firmonertinib or related compounds.
- •Other actionable oncogenic drivers (ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, except TP53/RB1).
- •Prior EGFR-TKI therapy or prohibited concomitant medications.
- •Unresolved toxicities \>CTCAE Grade 1 (except allowed conditions).
- •Symptomatic CNS metastases or spinal cord compression.
- •GI disorders impairing drug absorption.
- •Uncontrolled systemic diseases or active infections (HBV/HCV/HIV).
- •Interstitial lung disease (history or active).
- •Clinically significant cardiac abnormalities including QTc \>470 ms or LVEF \<50%.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Firmonertinib 160mg
Experimental
干预措施: Firmonertinib 160mg (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.
Percentage of patients achieving CR or PR per RECIST v1.1.
次要结局
- Progression-Free Survival (PFS)(From first dose to disease progression or death, whichever occurs first; followed for up to 24 months.)
- Disease Control Rate (DCR)(From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.)
- Duration of Response (DoR)(From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.)
- Incidence of Treatment-related adverse event (TRAE)(From first dose of therapy through 30 days after last dose of study treatment up to 24 months.)
- CNS Objective Response Rate (CNS-ORR)(From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.)
研究者
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