NCT06430437招募中3 期
A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) based on blinded independent central review (BICR)
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
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
- •Able and willing to provide a written informed consent
- •18-75 years old (inclusive of both ends)
- •ECOG score of 0 or
- •Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
- •Subjects with central laboratory- confirmed functional HER2 mutations
- •No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC.
- •Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1
- •Protocol-defined adequate organ function including cardiac, renal, hepatic function
排除标准
- •Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology.
- •Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release.
- •Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
- •With poorly controlled tumor-related pain.
- •previous or current with other malignancies.
- •Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia.
- •Subjects with active or previous autoimmune diseases.
- •Subjects with uncontrolled or severe cardiovascular diseases.
- •Subjects with active hepatitis B or hepatitis C.
研究组 & 干预措施
SHR-A1811
Experimental
干预措施: SHR-A1811 (Drug)
Standard of Care（Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin）
Active Comparator
干预措施: Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin (Drug)
结局指标
主要结局
Progression-free survival (PFS) based on blinded independent central review (BICR)
时间窗: Until progression, assessed up to approximately 2 years
Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)
次要结局
- Overall Survival (OS)(Until death, assessed up to approximately 3 years)
- Progression Free Survival (PFS) by investigator assessment(Until progression, assessed up to approximately 2 years)
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)(until to 90 days after the last dose，assessed up to approximately 3 years)
研究者
研究点 (1)
Loading locations...
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