NCT05165355招募中2 期
A Phase II, Single-armed Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection.
Tongji University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年12月28日最近更新:
适应症
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
- 90
- 试验地点
- 1
- 主要终点
- Disease Free Survival (DFS) rate at 2 years
研究概览
简要总结
This is a single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection.
The primary endpoint: 2-year DFS rate; The second endpoint: DFS
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
- •Subjects aged ≥18 and ≤75 years old；
- •ECOG performance status score 0-1；
- •Stage ⅠB-ⅡA（according to the 8th Edition of the AJCC Staging system）；
- •Complete surgical resection of the primary NSCLC is mandatory；
- •Histologically confirmed diagnosis of high-risk pathological subtype (micropapillary, solid pattern or spread through air spaces [STAS], etc.);
- •The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
- •Normal organ and bone marrow function measured before the study as defined below:
- •Hemoglobin (HGB)≥90g/L 2) White blood cell count (WBC) is 4.0~10×10^9/L 3) Absolute value of neutrophil (ANC)≥1.5×10^9/L 4) Platelet (PLT) count≥100×109/L 5) Serum total bilirubin (TBIL)≤1.5×ULN 6) AST and/or ALT≤2.5×ULN 7) International normalized ratio（INR）≤1.5 and activated partial thromboplastin time (APTT) is normal 8) Serum creatinine (SCr)≤1.5 × ULN
- •No previous systemic anti-tumor therapy for malignant tumor, such as chemotherapy, radiotherapy or hormonotherapy. No history of other malignancies, subjects with prostate cancer who received hormone therapy and had more than 5 years of DFS were excluded;
- •Subjects have voluntarily participated, signed and dated informed consent.
排除标准
- •Double primary lung cancer or multiple primary lung cancer;
- •Subjects with mental illness;
- •Presence or concomitant hemorrhagic diseases;
- •Pregnancy or lactation;
- •Known or suspected to be allergic to Furmonertinib and / or other components of their preparations.
研究组 & 干预措施
Experimental group
Experimental
Furmonertinib (80 mg orally, once daily) for 3 years.
干预措施: Furmonertinib (Drug)
结局指标
主要结局
Disease Free Survival (DFS) rate at 2 years
时间窗: From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years.
Assess the Efficacy of Adjuvant Furmonertinib as Measured by 2-year Disease Free Survival (DFS) rate.
次要结局
- Disease Free Survival (DFS)(From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years.)
研究者
Jiang Fan
Director of department of thoracic surgery
Tongji University
研究点 (1)
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