NCT07365410尚未招募2 期
Furmonertinib 160mg Versus Furmonertinib 80mg Combined With Chemotherapy (Carboplatin + Pemetrexed) as First-Line Treatment for EGFR-Mutated NSCLC Patients With Brain Metastases: A Multicenter Study of Efficacy and Safety
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Median Progression-Free Survival (PFS) as assessed by Investigator
研究概览
简要总结
This multicenter study evaluates the efficacy and safety of furmonertinib 160mg versus furmonertinib 80mg plus chemotherapy (carboplatin + pemetrexed) as first-line treatment for EGFR-mutated NSCLC patients with brain metastases. It aims to determine which approach is more effective and safer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IInclusion Criteria
- •Aged 18 to 75 years (male or female)
- •Histopathologically confirmed, unresectable, and non-radiocurable newly -diagnosed locally advanced or metastatic lung adenocarcinoma
- •Confirmed by local laboratory to have one of the following EGFR mutations: -19Del or L858R (single or mixed mutations are allowed)
- •Treatment-naive for locally advanced (not suitable for surgery/radiotherapy per investigator) or metastatic NSCLC; adjuvant/neoadjuvant therapy completed >6 months before first progression is allowed (≤6 months is considered pretreated)
- •At least one measurable tumor lesion per RECIST 1.1 (lesions previously treated with radiotherapy are excluded; if only one measurable lesion exists, biopsy is allowed but baseline imaging must be performed ≥14 days after biopsy)
- •Confirmed stable and asymptomatic brain metastases
- •Sufficient organ function (per laboratory tests): ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, HGB ≥90g/L; TBIL ≤1.5×ULN, AST/ALT ≤2.5×ULN (for liver metastasis: TBIL ≤3×ULN, AST/ALT ≤5×ULN); CrCL ≥50 ml/min (Cockcroft-Gault formula)
- •ECOG performance status 0-2 (no significant disease deterioration in 2 weeks before screening)
- •Expected survival >12 weeks after first dose
- •Non-pregnant women of childbearing potential (no pregnancy plan); women and men agree to use effective contraception during the study and 6 months after drug discontinuation
- •Voluntarily signs informed consent and understands the study procedures
排除标准
- •NSCLC with predominantly squamous cell histology, small cell lung cancer, neuroendocrine carcinoma, or other non-adenocarcinoma histologies
- •Concurrent positive for other driver genes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation); TP53, RB1, and BRAC mutations are excluded
- •Expected to receive other anti-tumor therapies during the trial
- •Major surgery (except vascular access or biopsy) within 4 weeks before first dose or planned during the trial
- •Use of CYP3A4 strong inhibitor within 7 days or strong inducer within 21 days before first dose; use of anti-tumor Chinese medicine within 2 weeks before first dose or planned during the trial
- •Participation in other clinical trials (investigational drug/device) within 4 weeks or 5 half-lives before first dose
- •Use of other anti-tumor drugs within 14 days before first dose
- •Spinal cord compression or symptomatic leptomeningeal metastasis
- •Toxicity from previous anti-tumor therapy not recovered to ≤CTCAE Grade 1 (except alopecia or platinum-induced peripheral neuropathy)
- •Symptomatic or unstable pleural/peritoneal effusion (stable ≥14 days after drainage is allowed)
- •History of other malignancies (except cured malignancies with no recurrence in 5 years: cervical carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma)
- •History of interstitial lung disease (ILD), drug-induced ILD, steroid-requiring radiation pneumonitis, or suspected ILD
- •Uncontrolled severe systemic diseases (e.g., hypertension, diabetes, NYHA III-IV heart failure, unstable angina, myocardial infarction within 1 year, active bleeding)
- •QTc >470 msec on resting ECG
- •Clinically significant QT prolongation or arrhythmias increasing QT risk (e.g., complete left bundle branch block, III° AV block, congenital long QT syndrome, severe hypokalemia, use of drugs causing QT prolongation)
- •Severe gastrointestinal dysfunction that impairs drug intake or absorption Infections requiring intravenous medication
- •Active mental illness or drug addiction
- •Known or suspected allergy to furmonertinib or its components
- •Pregnant or lactating women; women or their partners planning pregnancy during the study
- •Poor compliance (unable to follow study procedures)
- •Other conditions deemed unsuitable for enrollment by the investigator
研究组 & 干预措施
Furmonertinib 160mg Group
Experimental
Participants receive oral furmonertinib 160mg once daily as first-line treatment.
干预措施: Furmonertinib (Drug)
Furmonertinib 80mg + Chemotherapy Group
Active Comparator
Participants receive oral furmonertinib 80mg once daily combined with intravenous carboplatin + pemetrexed (cycle-based) as first-line treatment.
干预措施: Furmonertinib (Drug)
Furmonertinib 80mg + Chemotherapy Group
Active Comparator
Participants receive oral furmonertinib 80mg once daily combined with intravenous carboplatin + pemetrexed (cycle-based) as first-line treatment.
干预措施: carboplatin (Drug)
Furmonertinib 80mg + Chemotherapy Group
Active Comparator
Participants receive oral furmonertinib 80mg once daily combined with intravenous carboplatin + pemetrexed (cycle-based) as first-line treatment.
干预措施: pemetrexed (Drug)
结局指标
主要结局
Median Progression-Free Survival (PFS) as assessed by Investigator
时间窗: Approximately 18 months after the first patient begin study treatment
The time from the first dose of the study drug to the progression of the disease (Investigator-Assessed) or death for any reason according to investigator.
次要结局
- Objective Response Rate (ORR) as assessed by RECIST 1.1(Approximately 12 weeks following the first dose of study drug)
- Disease Control Rate (DCR) as assessed by RECIST 1.1(Approximately 18 months from the first patient begin study treatment)
- Central Nervous System (CNS) Objective Response Rate (CNS ORR) as assessed by RECIST 1.1(Approximately 12 weeks after the first dose of study drug)
- Central Nervous System (CNS) Disease Control Rate (CNS DCR) as assessed by RECIST 1.1(Approximately 18 months after the first dose of study drug)
- Central Nervous System Progression-Free Survival (CNS PFS) as assessed by RECIST 1.1(Approximately 18 months after the first dose of study drug)
- Median Overall Survival (OS)(Approximately 24 months after the first dose of study drug)
- Safety Profile (Adverse Events, AE) as assessed by CTCAE v5.0(From the start of study drug to 28 days after the last dose of study drug)
- Progression Pattern as assessed by RECIST 1.1 and Clinical Evaluation(Approximately 18 months after the first dose of study drug)
- Site Analysis of Disease Progression as assessed by RECIST 1.1 and Clinical Evaluation(Approximately 18 months after the first dose of study drug)
研究者
研究点 (1)
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