A Prospective, Single-Arm, Exploratory Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Progression Free Survival (PFS) by investigator assessment
研究概览
简要总结
The study enrolled patients with advanced or metastatic NSCLC harboring HER2 mutations, amplification, or overexpression who had progressed after ≥1 prior lines of anticancer therapy. After enrollment, participants received treatment with rezetamab plus pertuzumab until disease progression, intolerable toxicity, withdrawal of consent, or other conditions requiring treatment discontinuation.
详细描述
Patients who meet the following criteria are enrolled:
Aged 18-75 years Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition) Pathologically documented HER2 mutation, amplification, or overexpression Received ≥1 prior line of systemic anti-cancer therapy for advanced/metastatic disease Received SHR-A1811 combined with pertuzumab
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years
- •Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition)
- •Pathologically documented HER2 mutation, amplification, or overexpression
- •Received ≥1 prior line of systemic anti-cancer therapy for advanced/metastatic disease
- •There is at least one measurable lesion according to RECIST V1.1 criteria
- •ECOG score of 0 or
- •The expected survival is ≥12 weeks
排除标准
- •There are untreated or active central nervous system (CNS) tumor metastases
- •Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤
- •Pleural, ascites, or pericardial effusion requiring intervention occurred within 14 days prior to initial administration
- •Systemic antitumor therapy was performed 4 weeks prior to study initiation
- •Subjects who have previously received HER2-targeted therapy (excluding pan-HER tyrosine kinase inhibitors) or antibody-drug conjugates with a topoisomerase I inhibitor payload.
- •Use of strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within less than 5 drug half-lives prior to the first dose.
- •Has active infection requiring systemic treatment.
研究组 & 干预措施
SHR-A1811 combined with pertuzumab
Intravenous infusion，Q3 week, SHR-A1811 combined with pertuzumab
干预措施: SHR-A1811 (Drug)
结局指标
主要结局
Progression Free Survival (PFS) by investigator assessment
时间窗: Until progression, assessed up to approximately 2 years
次要结局
- Objective Response Rate （ORR）(Two years after the last subject was enrolled in the group)
- Overall Survival (OS)(Until death, assessed up to approximately 3 years)
- Disease Control Rate (DCR)(Two years after the last subject was enrolled in the group)
- Duration of Response (DOR)(Two years after the last subject was enrolled in the group)
- AE(until to 90 days after the last dose，assessed up to approximately 3 years)
研究者
Jianxing He
Guangzhou Medical University Affiliated First Hospital National Respiratory Research Center
The First Affiliated Hospital of Guangzhou Medical University