An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system)
- •No prior systemic therapy for ES-SCLC
- •Major organs are functioning well
- •Participant must keep contraception
排除标准
- •Histologically or cytologically confirmed mixed SCLC
- •Known history of severe allergy to any monoclonal antibody
- •Known hypersensitivity to carboplatin or etoposide
- •Pregnant or breastfeeding females
- •Patients with a known history of psychotropic drug abuse or drug addiction
- •Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment
研究组 & 干预措施
HLX07+HLX10+Chemotherapy
HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
干预措施: HLX07 (Drug)
HLX07+HLX10+Chemotherapy
HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
干预措施: HLX10 (Drug)
HLX07+HLX10+Chemotherapy
HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
干预措施: carboplatin and etoposide (Drug)
结局指标
主要结局
PFS
时间窗: Up to 2 years
Progression-free survival by investigator assessment per RECIST v1.1
ORR
时间窗: up to 2 years
Objective response rate by investigator assessment per RECIST 1.1
次要结局
未报告次要终点