Furmonertinib Combined With Cisplatin/Pemetrexed as Neoadjuvant Therapy in EGFR Mutated Stage IIA-IIIB Resectable Non-small Cell Lung Cancer (FORESEE): a Prospective, Open-label, Single-arm, Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. Surgery was performed 4-6 weeks after chemotherapy. The primary endpoint was objective response rate (ORR). Secondary endpoints included the pathological complete response (pCR) rate, major pathological response (MPR) rate, TNM downstaging rate, R0 resection rate, EFS, overall survival (OS), drug safety and surgical complications.
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
- •With written informed consent before any study procedure
- •Histology or cytology diagnose of non-small cell lung cancer within 60 days
- •Stage IIA-IIIB (T3N2M0 only), with resectable lesion(s) by radiology
- •EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
- •Without prior anti-tumor treatment
- •With at least one measurable lesions
- •ECOG performance status 0-1
- •Using adequate and effective contraception, women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age
排除标准
- •EGFR Exon 20 insertions positive
- •Mixed with small cell cancer, or other mixed types of lung cancer
- •Any prior anti-tumor treatment
- •Major surgery within 4 weeks before enrollment
- •Women with pregnancy or breastfeeding
- •Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrollment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrollment
- •With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
- •With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
- •Severe gastrointestinal diseases which may affect the intake and absorption of study drug
- •Prolongation of ECG QTc or with relative risk factors
- •History of interstitial lung disease or with relative risk factors
- •Inadequate organ function of hematology, liver and kidney
- •Allergic to study drugs or any component
- •Poor adherence or other situation judged by investigator
- •Patients who had participated other clinical studies of tumors
研究组 & 干预措施
furmonertinib plus platinum-based doublet chemotherapy
furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles
干预措施: Furmonertinib+cisplating/pemetrexed (Drug)
结局指标
主要结局
Objective response rate
时间窗: 7 days before surgery
the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST version 1.1
次要结局
- Major pathological response rate(7 days after surgery)
- Pathological complete response rate(7 days after surgery)
- R0 resection rate(7 days after surgery)
- the TNM downstaging rate(7 days before surgery)
- Event-free survival(2 years)
- drug safety and surgical complications(Adverse events (AEs) will be followed up for 30 days, serious adverse events (SAEs) will be followed up until resolution (assessed up to 60 days), and surgical complications will be followed up for 90 days.)
- Overall survival(Approximately 5 years following the first dose of study drugs)