A Randomized, Open-Label, Multicenter, Phase II Study of HLX07 (Anti-EGFR Antibody) +HLX10 (Anti-PD-1 Antibody) With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy and safety of HLX07 In Combination with HLX10 with or without Chemotherapy versus HLX10 with Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.
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
- 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 confirmed diagnosis of previously untreated, Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer
- •EGFR immunohistochemistry (IHC) H score ≥200 assessed by central lab
- •Has measurable disease as defined by RECIST 1.1 as determined by the IRRC
- •Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- •Has a life expectancy of greater than 12 weeks
- •Has adequate organ function
排除标准
- •Histologically non-squamous NSCLC must be exclused. For non-small-cell histology, if has squamous components be allowed
- •Has history of such as PD-1/PD-L1、EGFR、 CTLA4 targeted therapy
- •EGFR sensitivity mutation or ALK or ROS1 gene rearrangement need to be excluded
- •Has had other active malignancies within 5 years or at the same time
- •Has uncontrolled pleural effusion、pericardial effusion or ascites
研究组 & 干预措施
A arm: HLX10+chemo
Participants receive 300mg HLX10 IV every 3 weeks (Q3W) in combination with carboplaitin (AUC5 or 6) IV Q3W and nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle.
干预措施: HLX10+chemo (Drug)
B arm: HLX10+HLX07+chemo
Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W with chemo.
干预措施: HLX10+HLX07+chemo (Drug)
C arm: HLX10+HLX07
Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W.
干预措施: HLX10+HLX07 (Drug)
结局指标
主要结局
Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
时间窗: Up to 5 years
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by IRRC or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
Objective Response Rate (ORR) per RECIST 1.1 assessed by IRRC
时间窗: Up to 5 years
ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by IRRC. ORR will be determined for each treatment arm.
次要结局
- Adverse Events (AE)(Up to 5 years)
- Duration of Response (DOR) per RECIST 1.1 assessed by IRRC(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)