A Randomized, Double-Blind, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) + Chemotherapy (Carboplatin Nanoparticle Albumin Bound (Nab)-Paclitaxel) vs Chemotherapy (Carboplatin Nab-Paclitaxel) as First-Line Therapy for Locally Advanced or Metastatic Squamous Non Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 537
- 试验地点
- 92
- 主要终点
- tumor assessment
研究概览
简要总结
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10 + chemotherapy vs chemotherapy in subjects with locally advanced or metastatic squamous NSCLC who have not previously received systemic treatment.
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 nab paclitaxel) Arm B (placebo arm): Placebo + chemotherapy (carboplatin nab paclitaxel) The three stratification factors for randomization include: PD-L1 expression level (Tumor Proportion Scores [TPS]≥50%, 50%>TPS≥1%, TPS<1%), Asian population (yes or no), NSCLC stage (stage IIIB/IIIC or stage IV), and carboplatin AUC (5 or 6).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV (AJCC Edition 8) squamous NSCLC where surgery or radiotherapy cannot be performed.
- •No known sensitizing EGFR mutations or ALK, ROS1 gene rearrangements.
- •Major organs are functioning well
- •Participant must keep contraception
- •Patients with prior denosumab use who can agree to switch to bisphosphonate therapy for bone metastases in the study.
排除标准
- •Patients with histologically non-squamous NSCLC. Mixed tumors will be classified according to the primary cell type. Patients do not meet the requirements for enrollment if small cell components and neuroendocrine carcinoma components are present. For non-small cell histology, patients meet the requirements for enrollment if squamous components (e.g., adenosquamous) are present.
- •Patients with known history of severe hypersensitivity to any monoclonal antibody.
- •Patients with known hypersensitivity to any compositions of carboplatin or nab-paclitaxel.
- •Pregnant or breastfeeding females.
- •Patients with a known history of psychotropic drug abuse or drug addiction; or a history of alcohol abuse.
- •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
HLX10 + chemotherapy (carboplatin nab paclitaxel)
干预措施: HLX10 (Drug)
A
HLX10 + chemotherapy (carboplatin nab paclitaxel)
干预措施: carboplatin and nab paclitaxel (Drug)
B
Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
干预措施: carboplatin and nab paclitaxel (Drug)
B
Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
干预措施: Placebo (Drug)
结局指标
主要结局
tumor assessment
时间窗: Baseline until disease progression or death, whichever occurs first (up to approximately 24months)
Progression-free survival (PFS) (assessed by the independent radiology review committee \[IRRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
次要结局
未报告次要终点