A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 84
- 主要终点
- Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
研究概览
简要总结
The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.
详细描述
The study includes multiple substudy arms (Substudy A, B, C), which will evaluate immunotherapy-based combinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 or cytologically documented Stage IV metastatic, NSCLC
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
- •At least one measurable target lesion per RECIST v1.
- •Adequate organ function
- •Participants must be willing to provide adequate tumor tissue
排除标准
- •Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous
- •Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
- •Use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications ≤ 14 days before the initiation of study treatment (absorbable topical corticosteroids are not excluded).
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Platinum-Based Doublet (Drug)
B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Platinum-Based Doublet (Drug)
B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Domvanalimab (Drug)
B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Zimberelimab (Drug)
B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Quemliclustat (Drug)
A2: Domvanalimab + Zimberelimab
Domvanalimab and Zimberelimab, both administered by IV infusion
干预措施: Domvanalimab (Drug)
A3: Quemliclustat + Zimberelimab
Quemliclustat and Zimberelimab, both administered by IV infusion
干预措施: Quemliclustat (Drug)
A1: Domvanalimab + Zimberelimab
Domvanalimab and Zimberelimab, both administered by IV infusion
干预措施: Domvanalimab (Drug)
A1: Domvanalimab + Zimberelimab
Domvanalimab and Zimberelimab, both administered by IV infusion
干预措施: Zimberelimab (Drug)
A2: Domvanalimab + Zimberelimab
Domvanalimab and Zimberelimab, both administered by IV infusion
干预措施: Zimberelimab (Drug)
A3: Quemliclustat + Zimberelimab
Quemliclustat and Zimberelimab, both administered by IV infusion
干预措施: Zimberelimab (Drug)
B5: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Zimberelimab (Drug)
B5: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Domvanalimab (Drug)
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Platinum-Based Doublet (Drug)
B4: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Platinum-Based Doublet (Drug)
B5: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Platinum-Based Doublet (Drug)
B4: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Zimberelimab (Drug)
C1: Quemliclustat + Zimberelimab + Docetaxel
Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion
干预措施: Quemliclustat (Drug)
C2: Domvanalimab + Zimberelimab + Docetaxel
Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion
干预措施: Domvanalimab (Drug)
C1: Quemliclustat + Zimberelimab + Docetaxel
Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion
干预措施: Zimberelimab (Drug)
C1: Quemliclustat + Zimberelimab + Docetaxel
Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion
干预措施: Docetaxel (Drug)
B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Zimberelimab (Drug)
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Domvanalimab (Drug)
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Quemliclustat (Drug)
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Zimberelimab (Drug)
B4: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
干预措施: Domvanalimab (Drug)
C2: Domvanalimab + Zimberelimab + Docetaxel
Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion
干预措施: Zimberelimab (Drug)
C2: Domvanalimab + Zimberelimab + Docetaxel
Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion
干预措施: Docetaxel (Drug)
结局指标
主要结局
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
时间窗: Up to 58 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Up to 58 months
次要结局
- Investigational study treatments time of peak concentration (Tmax)(Up to 58 months)
- Overall Survival (OS)(From date of first dose until the date of death due to any cause (approximately 58 months))
- Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1(Up to 58 months)
- Disease Control Rate (DCR)(Up to 58 months)
- Duration of response (DoR) as determined by the Investigator according to RECIST v1.1(Up to 58 months)
- Investigational study treatments peak plasma or serum concentration (Cmax)(Up to 58 months)
- Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants(Up to 58 months)
- Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)(Up to 58 months)