A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Combined With Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 532
- 试验地点
- 1
- 主要终点
- PFS assessed by IRRC per RECIST v1.1
研究概览
简要总结
This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or stage IV squamous non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 combined with chemotherapy versus Tislelizumab combined with chemotherapy in patients with advanced squamous NSCLC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- •≥18 years old and ≤75 years old (at the time consent is obtained).
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Has a life expectancy of at least 3 months.
- •Has a histologically confirmed diagnosis of squamous NSCLC.
- •Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC]).
- •Has no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
- •Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- •Has adequate organ function.
排除标准
- •Histological diagnosis of non-squamous NSCLC.
- •Has EGFR-sensitive mutations or ALK gene translocations.
- •Known ROS1 rearrangement, MET exon 14 skipping mutation, or RET gene fusion positivite.
- •Is currently participating in a study of an investigational agent or using an investigational device.
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment.
- •Has undergone major surgery within 30 days of Study Day
- •Has known active central nervous system (CNS) metastases.
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- •Has an active infection requiring systemic therapy.
- •Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- •History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- •Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
- •Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.
研究组 & 干预措施
Experimental: AK112 in Combination With Paclitaxel Plus Carboplatin
AK112 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Carboplatin will be administered at AUC5, Q3W, intravenously (IV) for 4 cycles. Paclitaxel will be administered at 175 mg/m2, Q3W, intravenously (IV) for 4 cycles.
干预措施: AK112, Carboplatin, Paxlitaxel (Drug)
Active Comparator: Tislelizumab in Combination With Paclitaxel Plus Carboplatin
Tislelizumab will be administered at a dose of 200 mg intravenously (IV) every three weeks (Q3W). Carboplatin will be administered at AUC5, Q3W, intravenously (IV) for 4 cycles. Paclitaxel will be administered at 175 mg/m2, Q3W, intravenously (IV) for 4 cycles.
干预措施: Tislelizumab, Carboplatin, Paxlitaxel (Drug)
结局指标
主要结局
PFS assessed by IRRC per RECIST v1.1
时间窗: Up to approximately 2 years
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).
次要结局
- ORR assessed by IRRC per RECIST v1.1(Up to approximately 2 years)
- OS(Up to approximately 2 years)
- DoR assessed by IRRC per RECIST v1.1(Up to approximately 2 years)
- DCR assessed by IRRC per RECIST v1.1(Up to approximately 2 years)
- TTR assessed by IRRC per RECIST v1.1(Up to approximately 2 years)
- PFS assessed by investigator per RECIST v1.1(Up to approximately 2 years)
- ORR assessed by the investigator per RECIST v1.1(Up to approximately 2 years)
- DoR assessed by the investigator per RECIST v1.1(Up to approximately 2 years)
- DCR assessed by the investigator per RECIST v1.1(Up to approximately 2 years)
- TTR assessed by the investigator per RECIST v1.1(Up to approximately 2 years)
- AE(Up to approximately 2 years)
- ADA(Up to approximately 2 years)
- Cmax and Cmin(Up to approximately 2 years)
- PD-L1 expression(Up to approximately 2 years)