A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 620
- 试验地点
- 264
- 主要终点
- Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC
- •No prior systemic treatment for metastatic NSCLC
- •High tumor tissue PD-L1 expression
- •Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- •Adequate hematologic and end-organ function
- •For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.
排除标准
- •Known mutation in the EGFR gene or an ALK fusion oncogene
- •Symptomatic, untreated, or actively progressing central nervous system metastases
- •Active or history of autoimmune disease or immune deficiency
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- •Malignancies other than NSCLC within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- •Severe infection within 4 weeks prior to initiation of study treatment
- •Positive test result for human immunodeficiency virus (HIV)
- •Active hepatitis B or hepatitis C
- •Treatment with investigational therapy within 28 days prior to initiation of study treatment
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- •Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.
研究组 & 干预措施
Tiragolumab + Atezolizumab
Participants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
干预措施: Atezolizumab (Drug)
Tiragolumab + Atezolizumab
Participants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
干预措施: Tiragolumab (Drug)
Placebo + Atezolizumab
Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
干预措施: Atezolizumab (Drug)
Placebo + Atezolizumab
Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set
时间窗: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Overall Survival (OS) in the Primary Analysis Set
时间窗: From randomization to death from any cause (up to approximately 59 months)
Percentage of Participants With Adverse Events (AEs)
时间窗: Up to approximately 59 months
Percentage of Participants With Cytokine-Release Syndrome (CRS)
时间窗: Up to approximately 59 months
次要结局
- OS in the Secondary Analysis Set(From randomization to death from any cause (up to approximately 59 months))
- Investigator-Assessed Confirmed Objective Response Rate (ORR)(From randomization up to approximately 59 months)
- Investigator-Assessed Duration of Response (DOR)(From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 59 months))
- Investigator-Assessed PFS Rates at 6 Months and 12 Months(6 months, 12 months)
- OS Rates at 12 Months and 24 Months(12 months, 24 months)
- Investigator-Assessed PFS in the Secondary Analysis Set(From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months))
- Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score(From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months))