A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 71
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This randomized phase 2 open-label study will evaluate the safety and efficacy of zimberelimab (AB122) monotherapy, domvanalimab (AB154) in combination with zimberelimab, and domvanalimab in combination with zimberelimab and etrumadenant (AB928) in front-line, PD-L1 positive, metastatic non-small cell lung cancer.
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
- •Male or female participants; age ≥ 18 years
- •Histologically confirmed, treatment naive, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Must have at least 1 measurable lesion per RECIST v1.1
- •Adequate organ and marrow function
排除标准
- •Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs)
- •Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption)
- •History of trauma or major surgery within 28 days prior to the first dose of IMP
- •Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications
- •Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody with presence of Hepatitis C qualitative RNA or human immunodeficiency virus (HIV-1 and/or HIV-2) antibody at screening
- •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.
- •Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
研究组 & 干预措施
Arm 2 (domvanalimab and zimberelimab combination therapy)
Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.
干预措施: Zimberelimab (Drug)
Arm 1 (zimberelimab monotherapy)
Participants will receive zimberelimab as an intravenous (IV) infusion.
干预措施: Zimberelimab (Drug)
Arm 2 (domvanalimab and zimberelimab combination therapy)
Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.
干预措施: Domvanalimab (Drug)
Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)
Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion
干预措施: Domvanalimab (Drug)
Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)
Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion
干预措施: Etrumadenant (Drug)
Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)
Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion
干预措施: Zimberelimab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
ORR as assessed by RECIST v1.1
Progression-free survival (PFS)
时间窗: From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
PFS as assessed by RECIST v1.1
次要结局
- Duration of response (DoR)(From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years))
- Disease control rate (DCR)(From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years))
- Overall Survival (OS)(From randomization to death from any cause (up to approximately 5 years))
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)(From Screening until up to 90-100 days after the last dose (approximately 5 years))
- Pharmacokinetics of zimberelimab(Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years))
- Pharmacokinetics of domvanalimab(Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years))
- Pharmacokinetics of etrumadenant(Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years))
- Immunogenicity of zimberelimab(Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).)
- Immunogenicity of domvanalimab(Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).)