Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC With HER2 Alterations, a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 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 combined therapy 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 mutation (mutation, amplification, protein over-expression) using Disitamab Vedotin（RC48） combined with Tislelizumab or third-generation EGFR-TKI Furmonertinib, 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).".
- •Arm 1: HER2 alterations, no other driver gene mutations；
- •Arm 2: EGFR mutations accompanied by HER2 alterations;
- •Arm 3: HER2 gene mutations, no other driver gene alterations;
- •Number of treatment lines:
- •Arm 1-2: patients who have not previously received systemic treatment for advanced diseases;
- •Arm3:Failed with at least one line of standard treatment or intolerance;
- •Patients who have previously undergone neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy, or radiochemotherapy for the purpose of curing non metastatic diseases must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the randomization date.
- •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.
- •Estimated survival time ≥ 3 months.
排除标准
- •Central nervous system metastasis or meningeal metastasis with clinical symptoms.
- •Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- •Active hepatitis B (hepatitis B virus titer>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
- •Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
- •Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
研究组 & 干预措施
Arm 1: RC48+PD-1/PD-L1 inhibitor
干预措施: RC48+Tislelizumab+carboplatin (Drug)
Arm 2: RC48+Furmonertinib, 1L
干预措施: RC48+Furmonertinib, 1L (Drug)
Arm 3: RC48+Furmonertinib, 2L+
干预措施: RC48+Furmonertinib, 2L+ (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
- Disease control rate (DCR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)(Up to 24 months (data cut-off))
- Duration of Response (DoR) 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
Li Zhang, MD
Head of Oncology Department
Sun Yat-sen University