NCT05255406招募中2 期
A Prospective, Single-arm, Phase 2 Clinical Trial of Furmonertinib as the First-line Treatment in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- One-year Progression Free Survival Rate
研究概览
简要总结
The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥18 years old;
- •Locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology (stage ⅢB-Ⅳ, according to the 8th Edition of the AJCC Staging system);
- •The tumour harbours one of the most common EGFR mutations (19del or L858R);
- •The programmed death-ligand 1 (PD-L1) tumoral expression is positive;
- •No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;
- •According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline;
- •ECOG performance status score 0-2；
- •Subjects have voluntarily participated, signed and dated informed consent.
排除标准
- •Lung squamous carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma) and small cell lung cancer;
- •Subjects have no measurable tumor lesion at baseline;
- •Subjects with spinal cord compression or symptomatic brain metastases;
- •Subjects are suitable for surgery;
- •Previous therapy with platinum-based chemotherapy, EGFR-TKIs, or anti-PD1/PD-L1 agents;
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 × ULN, or serum total bilirubin (TBIL)>1.5 × ULN, or Cr>1.0×ULN;
- •Absolute value of neutrophil (ANC)<1.5 × 109/L, or platelet (PLT) count<75 × 109/L, or hemoglobin (HGB)<90 g/L;
- •Any of the following disease within 12 months: myocardial infarction, severe/unstable stenocardia, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident;
- •Women who are pregnancy or lactation, or fertile but not using contraception;
- •Suffering from other serious acute or chronic physical or mental problems;
- •Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.
研究组 & 干预措施
Furmonertinib
Experimental
Furmonertinib (160mg)
干预措施: Furmonertinib (160mg) (Drug)
结局指标
主要结局
One-year Progression Free Survival Rate
时间窗: One year after inclusion
Percentage of subjects still alive and progression free one year after inclusion in the study.
次要结局
- One-year Overall Survival Rate(one year after inclusion)
- Progression Free Survival(Approximately 2 years following the first dose of study drugs)
- Adverse Events(Until 28 days from the last dose of study drugs or initiation of a new anticancer treatment)
- Objective Response Rate(Approximately 2 years following the first dose of study drugs)
研究者
Huiyu
associate senior doctor
Fudan University
研究点 (1)
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