A Phase III, Randomized, Double-blind Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Stage IIB, IIIA, or Select IIIB, PD-L1 Positive, Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy

Hoffmann-La Roche39 个研究点分布在 11 个国家目标入组 56 人2024年3月21日

干预措施Atezolizumab Tiragolumab Placebo

概览

阶段: 3 期
干预措施: Atezolizumab
疾病 / 适应症: 未指定
发起方: Hoffmann-La Roche
入组人数: 56
试验地点: 39
主要终点: Percentage of Participants With Adverse Events (AEs)
状态: 已完成
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this study was to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy.

详细描述

With Protocol Amendment 2, enrollment will be stopped. The primary objective of the study has been changed to a safety objective and no other analysis will be conducted

注册库

clinicaltrials.gov

开始日期

2024年3月21日

结束日期

2025年12月16日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Hoffmann-La Roche

责任方

Sponsor

入排标准

入选标准

•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB NSCLC of either non-squamous or squamous histology
•Participants must have had complete resection of NSCLC
•Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy
•Participants must have recovered adequately from surgery and from adjuvant chemotherapy
•Tumor cell PD-L1 expression at \>/= 1%
•Adequate hematologic and end-organ function.

排除标准

•Any history of prior NSCLC within the last 5 years
•Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy
•NSCLC known to have mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene

研究组 & 干预措施

Atezolizumab + Tiragolumab

Participants will receive atezolizumab and tiragolumab intravenously (IV).

干预措施: Atezolizumab

Atezolizumab + Tiragolumab

Participants will receive atezolizumab and tiragolumab intravenously (IV).

干预措施: Tiragolumab

Atezolizumab + Placebo

Participants will receive atezolizumab and placebo IV.

干预措施: Atezolizumab

Atezolizumab + Placebo

Participants will receive atezolizumab and placebo IV.

干预措施: Placebo

结局指标

主要结局

Percentage of Participants With Adverse Events (AEs)

时间窗: Up to approximately 2 years

次要结局

Overall Survival (OS)(Up to approximately 15 years)
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab(Up to approximately 1 year)
Percentage of Participants Who Maintained or Meaningfully Improved from Baseline in Patient-reported Role, Emotional, and Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL)(Up to approximately 1 year)
Serum Concentration of Atezolizumab(Up to approximately 1 year)
Percentage of Participants With Adverse Events (AEs)(Up to approximately 15 years)
Percentage of Participants With ADAs to Atezolizumab(Up to approximately 1 year)
DFS Rate(Year 3, Year 5, Year 7)
Serum Concentration of Tiragolumab(Up to approximately 1 year)