NCT06483672尚未招募2 期
Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases, a Prospective Phase II Single-arm Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 27
- 主要终点
- Central Nervous System Objective Response Rate (CNS ORR)
研究概览
简要总结
The goal of this clinical trial is to learn if furmonertinib plus anlotinib works to treat participants with lung adenocarcinoma with EGFR mutations and brain metastases. It will also learn about the safety of furmonertinib plus anlotinib. The main questions it aims to answer are:
- Does furmonertinib plus anlotinib increase the number of participants who has a significant tumor shrinkage?
- What medical problems do participants have when taking furmonertinib plus anlotinib? Researchers will evaluate the safety and efficacy of furmonertinib plus anlotinib.
Participants will:
- Take furmonertinib(every day) and anlotinib(two weeks on and one week off)
- Visit the clinic once every 3 weeks for checkups and tests.
- Keep a diary of their symptoms.
详细描述
The objective of this study is to explore the effectiveness and safety of furmonertinib and anlotinib as first-line treatment for patients with EGFR mutation and brain metastasis lung adenocarcinoma.
This clinical trial adopts a single-center, prospective, single-arm phase II trial design. Each 3 weeks constitute a treatment cycle until disease progression or intolerance.
After screening, eligible patients will be enrolled in the study. They will receive furmonertinib and anlotinib as first-line treatment. The patients will undergo regular visits, and researchers will collect data on efficacy and safety.
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 aged ≥18 years old;
- •Histologically or cytopathologically confirmed non-small cell lung cancer (NSCLC) ;
- •According to RANO-BM, the subject has at least 1 intracranial measurable lesion;
- •Tumor tissue samples or blood samples are confirmed to be EGFR mutations;
- •ECOG PS 0-1;
- •Life expectancy >12 weeks;
- •No prior systemic antitumor therapy for metastatic NSCLC
排除标准
- •Patients without lung adenocarcinoma, including lung squamous cell carcinoma or mixed histological type, etc;
- •Expected to receive other anti-tumor therapy other than the investigational product during the study;
- •Having previously received systematic anti-tumor therapy
- •Having received the following therapies: (1) Having been irradiated for > 30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product; (2) Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; (3) Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; (4) Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; (5) Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product;
- •Having a history of other malignant tumor, or other concurrent malignant tumors;
- •The toxicity caused by previous anti-tumor therapy has not recovered to <= CTCAE grade 1 (CTCAE 5.0) (except alopecia, sequelae of previous platinum-related neurotoxicity) ;
- •Previous interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected interstitial lung disease;
- •Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product;
- •Recently active digestive disease
- •The patient is prone to bleeding or has active bleeding; Any bleeding event ≥CTCAE grade 3 within 28 days prior to the first study drug;
- •Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval; for example, QTc > 470 ms on ECG at resting state, complete left bundle branch block, degree III atrioventricular block, congenital long QT syndrome, serious hypokalemia, or current use of drugs that may lead to prolonged QT interval;
- •Bone marrow reserve, liver, kidney organs and other functions are insufficient;
- •There has been an active venous thrombosis event within the last 6 months;
- •Known Active hepatitis B virus , hepatitis C virus (positive HCV Ab) or human immunodeficiency virus (positive HIV antibody) infection;
- •Infectious disease requiring intravenous medication;
- •Known history of mental disease or drug abuse, and currently having an attack or still taking drugs;
- •Known or suspected allergy to Furmonertinib or other components of its preparation;
- •Female subjects or female partners of male subjects who are pregnant or lactating, or plan to be pregnant during the study;
- •Poor compliance, inability to comply with the study procedures, restriction or requirements;
- •Other conditions that are considered by investigators as unsuitable to participate in this study.
研究组 & 干预措施
Furmonertinib combine with anlotinib
Experimental
Furmonertinib 80mg, once daily, orally Anlotinib 12mg, once daily (days 1-14, 21 days per cycle), orally
干预措施: Furmonertinib (Drug)
Furmonertinib combine with anlotinib
Experimental
Furmonertinib 80mg, once daily, orally Anlotinib 12mg, once daily (days 1-14, 21 days per cycle), orally
干预措施: Anlotinib (Drug)
结局指标
主要结局
Central Nervous System Objective Response Rate (CNS ORR)
时间窗: Approximately 12 weeks after the last patient begin study treatment
Proportion of subjects whose CNS tumors are assessed as complete response(CR) or partial response(PR) according to RANO-BM.
次要结局
- Central Nervous System Disease Control Rate (CNS DCR)(Approximately 12 weeks after the last patient begin study treatment)
- Objective Response Rate (ORR)(Approximately 12 weeks after the last patient begin study treatment)
- Disease Control Rate (DCR)(Approximately 12 weeks after the last patient begin study treatment)
- Progression Free Survival (PFS)(Approximately 18 months after the first patient begin study treatment)
- Overall survival (OS)(Approximately 24 months after the last patient begin study treatment)
- Central Nervous System Progression Free Survival (PFS)(Approximately 18 months after the first patient begin study treatment)
- Adverse Events (AEs)(rom the start of study drug to 28 days after the last dose of study drug)
研究者
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