Open Label, Multicenter Phase Ib / II Study of Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- ORR(Objective response rate)
研究概览
简要总结
To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification.
详细描述
To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Can fully understand and sign informed consent form(ICF) voluntarily Male and female patients 18-80 (inclusive) years of age
- •Stage: IIIb/IIIc/IV (AJCC version 8)
- •ECOG Performance Status (PS): 0-1
- •At least one measurable lesion as per RECIST 1.1
排除标准
- •Subjects with characterizedALK or ROS1 activating mutations that predict sensitivity to anti-ALK-therapy or anti-ROS1-therapy; T790 mutations is uknown or positive
- •Patients who have symptomatic CNS metastasis which is neurologically unstable or those who have CNS disease requiring increase in the dose of steroid. (Note: Patients with controlled CNS metastasis can participate in the trial. Before entering the study, patients should have finished radiotherapy, or have received operation for CNS tumor metastasis at least two weeks before. Patients' neurological function must be in a stable state; no new neurological deficit is found during clinical examination and no new problem is found during CNS imaging examinations. If patients need to use steroids to treat CNS metastasis, the therapeutic dose of steroid should be stable for ≥3 months at least two weeks prior to entering the study.)
- •Prior exposure to MET-directed or third generation EGFR inhibitors therapy Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the study drug or who have not recovered from the side effect of such therapy
- •Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product
研究组 & 干预措施
Glumetinib+Osimertinib
The investigational product Glumetinib will be orally administrated when fasting at dose level of 300mg QD and Osimertinib will be orally administrated when fasting at dose level of 80mg QD
干预措施: Glumetinib (Drug)
结局指标
主要结局
ORR(Objective response rate)
时间窗: through study completion, an average of 1 year
the sum ratio of partial response and complete response(determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1)
次要结局
- ORR(Objective response rate, assessed as per investigators)(through study completion, an average of 1 year)
- DOR(Duration of response)(The time from the date of first documented partial response or complete response to progressive disease or death, an average of 6 months)
- OS(Overall survival)(Through study completion, an average of 1 year)