This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined With Furmonertinib Mesylate in First-line Treatment of Advanced No-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and Efficacy of drug therapy
研究概览
简要总结
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced no-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.
详细描述
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced No-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.
This study is a single arm, phase II study, including 18 to 36 subjects; Common Terminology Criteria for Adverse Events 5.0 standard was used to evaluate adverse events of drugs, and Response Evaluation Criteria In Solid Tumors 1.1 was used to evaluated efficacy.
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
- •Locally advanced and/or metastatic NSCLC diagnosed histologically and/or cytologically;
- •Age 18 and above; Eastern Cooperative Oncology Group Physical condition: 0~1; The expected survival time is more than 3 months;
- •The previous report confirmed the presence of an EGFR gene exon 19 deletion mutation or exon 21 L858R mutation, and the investigator verified that the report reflects the patient's current genetic status.
- •There is at least one measurable lesion other than brain lesion defined by Response Evaluation Criteria In Solid Tumors 1.1 standard;
- •The main organs are functioning well,Adequate laboratory indicators.
- •Women of childbearing age should agree to use contraceptives during the study period and for a period of six months after the study; Negative serum or urine pregnancy test within 7 days prior to study inclusion, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study period;
- •Patients voluntarily participated in this study, signed informed consent, and had good compliance.
排除标准
- •Prior history of targeted Epidermal Growth Factor Receptor therapy and anti-angiogenic drugs
- •Received chemical or biological drugs after the diagnosis of advanced stage;
- •Subjects had undergone surgery , radiation therapy or other anticancer therapies within 4 weeks prior to the commencement of study treatment; Subjects who have previously received local radiation therapy may be enrolled if the following conditions are met: more than 4 weeks after the end of radiation therapy ;
- •Within 2 weeks before the start of the study, patients were treated with Chinese medicines
- •Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator has determined that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
- •Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage ;
- •Brain metastases with symptoms or symptom control time less than 2 weeks;
研究组 & 干预措施
Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate
Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Furmonertinib Mesylate：The dose of Furmonertinib Mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast.
Take medicine continuously for 3 weeks (21 days) for 1 cycle.
干预措施: Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate (Drug)
结局指标
主要结局
Safety and Efficacy of drug therapy
时间窗: up to 4 weeks
The probability and severity of first cycle adverse events (AE) and serious adverse events (SAE) (based on Common Terminology Criteria for Adverse Events 5.0) and abnormal laboratory test indicators;
次要结局
- The overall efficacy was assessed by the investigators(up to 48 weeks)
研究者
Yuankai Shi
Director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences