An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Advanced nsqNSCLC Patients With High EGFR Expression
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Combination with Chemotherapy or Monotherapy in Advanced Non-squamous Non-small Cell Lung Cancer (nsqNSCLC) Patients with High EGFR Expression
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
- •Good Organ Function
- •Expected survival time ≥ 3 months
- •Histologically confirmed, advanced/recurrent or metastatic nsqNSCLC
- •Measurable lesion according RECISTv1.1 by investigator
- •High EGFR expression H score ≥200
- •ECOG score 0-1
排除标准
- •Histologically, squamous NSCLC should be excluded. For tumors with adenocarcinoma and squamous carcinoma, if the adenoid component is dominant and the squamous component is < 5%, the patients meet the inclusion requirements.
- •Previous treatment with EGFR inhibitors
- •Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- •Active clinical severe infection;
- •A history of other malignancies within 5 years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin,etal.
研究组 & 干预措施
B
干预措施: HLX07+docetaxel (Drug)
A
干预措施: HLX07+carboplatin+pemetrexed (Drug)
C
干预措施: HLX07 (Drug)
结局指标
主要结局
ORR
时间窗: up to 2 years
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
PFS
时间窗: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1
次要结局
- OS(from the date of first dose until the date of death from any cause，assessed up to 2 years)