Disitamab Vedotin（RC48）Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)
研究概览
简要总结
Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.
详细描述
This study will explore the treatment of locally advanced or metastatic non-small cell lung cancer with HER2 mutation, amplification, or HER2 protein overexpression, using Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs, in the aim of providing new treatment strategies for lung cancer patients with HER2 pathway activation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 (inclusive) or above, regardless of gender.
- •Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).".
- •HER2 alterations include HER2 gene mutations, gene amplification and HER2 protein over-expression;
- •Number of treatment lines:
- •Arm1: patients who have not previously received systemic treatment for advanced diseases;
- •Arm2: Previously received first line of third-generation EGFR-TKIs treatment with local progression, oligometastasis, or slow progression, and evaluated by the researchers to continue to benefit from third-generation EGFR-TKIs treatment;
- •Arm3: Previously received first line of third-generation EGFR-TKIs treatment with extensively progression, and evaluated by the researchers not likely to continue to benefit from third-generation EGFR-TKIs treatment;
- •There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
- •ECOG fitness status score: 0 or 1 point.
排除标准
- •Central nervous system metastasis or meningeal metastasis with clinical symptoms.
- •Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
- •Have a history of severe cardiovascular disease.
- •Have a history of interstitial lung disease or drug-induced interstitial lung disease requiring steroids treatment; radiation pneumonia.
- •Have a history of neurological disorders or mental illnesses, including epilepsy or dementia.
- •Pregnant or lactating women.
- •The researcher believes that the subject is not suitable to participate in this clinical study due to other reasons.
研究组 & 干预措施
Arm1: Treatment Naive NSCLC
RC48+third-generation EGFR TKIs in treatment-naive patients harboring EGFR mutation and HER2 alterations
干预措施: Disitamab Vedotin (Drug)
Arm1: Treatment Naive NSCLC
RC48+third-generation EGFR TKIs in treatment-naive patients harboring EGFR mutation and HER2 alterations
干预措施: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) (Drug)
Arm2: Locally Progressed
This cohort includes ERBB2 altered patients after third-generation EGFR-TKIs treatment with locally or slowly progressed disease, who may continue to benefit from third-generation EGFR-TKIs treatment under investigators' evaluation.
干预措施: Disitamab Vedotin (Drug)
Arm2: Locally Progressed
This cohort includes ERBB2 altered patients after third-generation EGFR-TKIs treatment with locally or slowly progressed disease, who may continue to benefit from third-generation EGFR-TKIs treatment under investigators' evaluation.
干预措施: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) (Drug)
Arm3: Extensively Progressed
This cohort includes ERBB2 altered patients after third-generation EGFR-TKIs treatment with extensively progressed disease, who may be less likely to benefit from third-generation EGFR-TKIs treatment under investigators' evaluation.
干预措施: Disitamab Vedotin (Drug)
Arm3: Extensively Progressed
This cohort includes ERBB2 altered patients after third-generation EGFR-TKIs treatment with extensively progressed disease, who may be less likely to benefit from third-generation EGFR-TKIs treatment under investigators' evaluation.
干预措施: pyrotinib (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)
时间窗: Up to 24 months (data cut-off)
Percentage of Participants who have a complete response (CR) or partial response (PR) as assessed by investigator according to RECIST 1.1
次要结局
- Duration of Response (DoR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)(Up to 24 months (data cut-off))
- Disease control rate (DCR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)(Up to 24 months (data cut-off))
- Progression-free survival (PFS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)(Up to 24 months (data cut-off))
- Overall Survival (OS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)(Up to 24 months (data cut-off))
研究者
Jie Wang
Head of Oncology Department
Cancer Institute and Hospital, Chinese Academy of Medical Sciences