A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Efficacy and Safety of HLX10 in Combination With Chemotherapy in Previously Untreated Patients With ES-SCLC
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 585
- 试验地点
- 5
- 主要终点
- OS
研究概览
简要总结
This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer.
Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:
Arm A (HLX10 arm): HLX10 + chemotherapy (Carboplatin-Etoposide) ; Arm B (placebo arm): Placebo + chemotherapy (Carboplatin-Etoposide); The three stratification factors for randomization include: PD-L1 expression level (negative, positive, not available), Brain metastasis (yes versus no), Age (≥ 65 years versus < 65 years)
详细描述
After screening, subjects meeting the inclusion criteria and none of the exclusion criteria will be enrolled. Included subjects will be treated with HLX10 or placebo in combination with chemotherapy once every 3 weeks, until disease progression, death, intolerable toxicity, withdrawal of informed consent, or occurrence of other reasons specified in the protocol (whichever occurs first).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
A
HLX 10+chemotherapy (Carboplatin-Etoposide)
干预措施: HLX10 (Drug)
A
HLX 10+chemotherapy (Carboplatin-Etoposide)
干预措施: carboplatin and etoposide (Drug)
B
Placebo+chemotherapy (Carboplatin-Etoposide)
干预措施: carboplatin and etoposide (Drug)
B
Placebo+chemotherapy (Carboplatin-Etoposide)
干预措施: placebo (Drug)
结局指标
主要结局
OS
时间窗: The period from randomization through death regardless of causality (up to approximately 56 months)
Overall survival (OS)
次要结局
- Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1(From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months).)
- Objective Response Rate(From baseline until PR or CR, whichever occurs first (up to approximately 56 months))
- Duration of Response(From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months).)