NCT05990127尚未招募3 期
A Randomized, Double-blind, Phase III Trial to Compare the Efficacy and Safety of AK104 Combined With Chemotherapy to Tislelizumab Combined With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer (NSCLC)
Akeso62 个研究点 分布在 1 个国家目标入组 642 人开始时间: 2023年11月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 642
- 试验地点
- 62
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS < 1%.
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
- •The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
- •Aged ≥18 years when the subject signed the informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy ≥ 3 months.
- •Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer [AJCC] 8th edition).
- •No prior systemic therapy for advanced or metastatic NSCLC was received.
- •PD-L1 TPS < 1%.
- •No EGFR sensitive mutations or ALK gene translocation alterations.
排除标准
- •Histologically confirmed small cell lung cancer (SCLC).
- •NSCLC with driver gene mutations for approved targeted drug indications.
- •Active central nervous system (CNS) metastases were present.
- •Pulmonary radiation therapy > 30 Gy within 6 months prior to first dose.
- •Active malignant tumors within the past 5 years, except for tumors in this study and scured local tumors.
- •Pregnant or lactating women.
- •Clinically significant cardiovascular or cerebrovascular disease.
- •Subjects with a known history of severe hypersensitivity to other monoclonal antibodies. A known history of allergy or hypersensitivity to all investigational drugs or any of their components.
- •Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.
- •Known active pulmonary tuberculosis.
- •Patients with active hepatitis B or active hepatitis C.
- •Known medical history of immunodeficiency or positive HIV test.
研究组 & 干预措施
Tislelizumab arm
Active Comparator
干预措施: Paclitaxel (Drug)
AK104 arm
Experimental
干预措施: AK104 (Drug)
AK104 arm
Experimental
干预措施: carboplatin (Drug)
AK104 arm
Experimental
干预措施: Pemetrexed (Drug)
AK104 arm
Experimental
干预措施: Paclitaxel (Drug)
Tislelizumab arm
Active Comparator
干预措施: Tislelizumab (Drug)
Tislelizumab arm
Active Comparator
干预措施: carboplatin (Drug)
Tislelizumab arm
Active Comparator
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Overall Survival(OS)
时间窗: Through Database Cutoff Date (Up to approximately 39 months)
OS is defined as the time from randomization to death due to any cause.
Progression-Free Survival(PFS) by investigator(INV)
时间窗: Through Database Cutoff Date (Up to approximately 39 months)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1
次要结局
- Antidrug antibodies (ADA) of AK104(Through Database Cutoff Date (Up to approximately 39 months))
- Progression-Free Survival(PFS) by Blind independent center review(BIRC)(Through Database Cutoff Date (Up to approximately 39 months))
- Objective response rate (ORR) was assessed by INV(Through Database Cutoff Date (Up to approximately 39 months))
- Disease control rate (DCR) was assessed by INV(Through Database Cutoff Date (Up to approximately 39 months))
- Time to response (TTR) was assessed by INV(Through Database Cutoff Date (Up to approximately 39 months))
- Duration of response (DOR) was assessed by INV(Through Database Cutoff Date (Up to approximately 39 months))
- Objective response rate (ORR) was assessed by BIRC(Through Database Cutoff Date (Up to approximately 39 months))
- Disease control rate (DCR) was assessed BIRC(Through Database Cutoff Date (Up to approximately 39 months))
- Time to response (TTR) was assessed by BIRC(Through Database Cutoff Date (Up to approximately 39 months))
- Duration of response (DOR) was assessed by BIRC(Through Database Cutoff Date (Up to approximately 39 months))
- The number of subjects experiencing adverse events (AEs)(Through Database Cutoff Date (Up to approximately 39 months))
- Pharmacokinetic(Through Database Cutoff Date (Up to approximately 39 months))
- Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(Through Database Cutoff Date (Up to approximately 39 months))
- Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 module (EORTC QLQ-LC29)(Through Database Cutoff Date (Up to approximately 39 months))
研究者
研究点 (62)
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