An Open-label, Phase II Study of KN046 Evaluating the Efficacy and Safety of KN046 Plus Platinum-based Doublet Chemotherapy as First Line Therapy in Advanced Non-small Cell Lung Cancer Subjects.
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
研究概览
简要总结
This is a phase II study of KN046 plus platinum-based doublet chemotherapy in previously untreated advanced non-squamous and squamous NSCLC subjects.
The study will assess primarily the safety and efficacy of KN046 plus platinum-based doublet chemotherapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a histologically or cytologically confirmed diagnosis of stage IV NSCLC;
- •Has not received prior systemic treatment for metastatic NSCLC;
- •Has measurable disease based on RECIST 1.
- •Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- •Has adequate organ function.
- •Has provided tumor tissue from locations not radiated prior to biopsy.
排除标准
- •Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
- •Previously untreated or symptomatic central nervous system (CNS) metastases
- •Has received a live-virus vaccination within 28 days of planned treatment start.
- •Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody and chemotherapy.
- •Has or had active autoimmune disease.
研究组 & 干预措施
KN046 + carboplatin/paclitaxel
KN046 5 mg/kg IV every three weeks (Q3W) +Carboplatin AUC5 IV Q3W x 4 cycles + Paclitaxel 500 mg/m2 IV Q3W x 4 cycles
干预措施: KN046 (Biological)
KN046 + carboplatin/paclitaxel
KN046 5 mg/kg IV every three weeks (Q3W) +Carboplatin AUC5 IV Q3W x 4 cycles + Paclitaxel 500 mg/m2 IV Q3W x 4 cycles
干预措施: Paclitaxel (Drug)
KN046 + carboplatin/paclitaxel
KN046 5 mg/kg IV every three weeks (Q3W) +Carboplatin AUC5 IV Q3W x 4 cycles + Paclitaxel 500 mg/m2 IV Q3W x 4 cycles
干预措施: Carboplatin (Drug)
KN046 + carboplatin/pemetrexed
KN046 5 mg/kg IV Q3W +Carboplatin AUC5 IV Q3W x 4 cycles + Pemetrexed 500 mg/m2 IV Q3W x 4 cycles
干预措施: KN046 (Biological)
KN046 + carboplatin/pemetrexed
KN046 5 mg/kg IV Q3W +Carboplatin AUC5 IV Q3W x 4 cycles + Pemetrexed 500 mg/m2 IV Q3W x 4 cycles
干预措施: Pemetrexed (Drug)
KN046 + carboplatin/pemetrexed
KN046 5 mg/kg IV Q3W +Carboplatin AUC5 IV Q3W x 4 cycles + Pemetrexed 500 mg/m2 IV Q3W x 4 cycles
干预措施: Carboplatin (Drug)
结局指标
主要结局
Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
时间窗: Up to approximately 12 months
For participants who demonstrated a confirmed response (Complete Response \[CR\]: Disappearance of all target lesions or Partial Response \[PR\]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression as assessed by RECIST 1.1 or death.
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
时间窗: Up to approximately 12 months
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by RECIST 1.1. ORR.
次要结局
- Number of Participants Who Experienced a treatment-emergent adverse event (TEAE)(Up to approximately 12 months)
- Number of Participants Who Experienced an immune-related AE (irAE)(Up to approximately 12 months)