NCT05466149进行中（未招募）2 期
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations
Allist Pharmaceuticals, Inc.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月27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
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- ORR, Objective Response Rate
研究概览
简要总结
This is a Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations.
The study plans to enroll approximately 100 patients from approximately 70 sites. Patients are locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy. Furmonertinib Mesilate will be treated 240 mg QD until disease progression or unacceptable toxicity.
Primary endpoint is ORR. Secondary endpoints include DOR, DCR, DepOR, PFS, OS, CNS ORR, CNS DOR, CNS PFS, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).
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
- •Age ≥ 18 years at time of signing Informed Consent Form
- •Histologically or cytologically documented, locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy
- •Documented validated results from local or central testing (as designated by the Sponsor) of blood or tumor tissue confirming the presence of an EGFR exon 20 insertion mutation
- •Documented radiologic progression on or after prior platinum-based chemotherapy (with or without anti-PD1/PD-L1 agents) in the locally advanced or metastatic setting
- •Documented radiologic disease progression during or after the last systemic anticancer therapy before the first dose of furmonertinib
- •Measurable disease per RECIST v1.1
- •ECOG performance status of 0 or 1
- •Life expectancy of ≥ 12 weeks
- •Patients with CNS metastases are eligible, provided they meet all of the following criteria: Measurable disease outside the CNS; No ongoing requirement for corticosteroids as therapy for CNS metastases, with corticosteroids discontinued for ≥ 2 weeks prior to enrollment; No ongoing symptoms attributed to CNS metastases; No active CNS metastases or spinal cord compression (i.e., progressing or requiring anticonvulsants or corticosteroids for symptomatic control); No evidence of interim CNS disease progression between the completion of CNS-directed therapy and the screening radiographic study; Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days
- •Adequate hematologic and organ function within 14 days prior to initiation of study treatment
- •For women of childbearing potential or men who are not surgically sterile: Agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs or sperm
排除标准
- •Prior treatment with any EGFR-targeting agents (e.g., EGFR tyrosine kinase inhibitors [TKIs], monoclonal antibodies, or bispecific antibodies).
- •More than 3 prior systemic anticancer therapy regimens for locally advanced or metastatic NSCLC
- •Inability or unwillingness to swallow pills
- •Severe acute or chronic infections
- •Previous interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected ILD
- •History of or active clinically significant cardiovascular dysfunction
- •Mean resting corrected QT interval (QTc) > 470 msec, obtained from triplicate ECGs, using the screening clinic ECG machine derived Fridericia's formula (QTcF) value
- •Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval (e.g., complete left bundle branch block, degree III atrioventricular block, second-degree heart block, PR interval > 250 msec, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives, serious hypokalemia, heart failure) or current use of the drugs that may lead to prolonged QT interval.
- •AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, endocrinopathy managed with replacement therapy, or Grade ≤ 2 peripheral neuropathy.
研究组 & 干预措施
Furmonertinib 240mg QD
Experimental
Treating patients of locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy.
干预措施: Furmonertinib (Drug)
结局指标
主要结局
ORR, Objective Response Rate
时间窗: Approximately 7.5 months following the last patient enrolled
Percentage of patients with a confirmed CR or PR relative to the total number of patients.
次要结局
- DOR, Duration of response(Approximately 7.5 months following the last patient enrolled)
- DCR, Disease control rate(Approximately 7.5 months following the last patient enrolled)
- Depth of response(Approximately 7.5 months following the last patient enrolled)
- PFS, Progression Free Survival(Approximately 7.5 months following the last patient enrolled)
- OS, Overall Survival(Approximately 3 years following the last patient enrolled)
- CNS ORR, CNS DOR, CNS PFS(Approximately 7.5 months following the last patient enrolled)
- Adverse Events(Until 28 days from the last dose of study drugs or initiation of a new anticancer treatment)
- Maximum Plasma Concentration [Cmax](Approximately 7.5 months following the last patient enrolled)
- Minimum Plasma Concentration [Cmin](Approximately 7.5 months following the last patient enrolled)
研究者
研究点 (2)
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