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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 37
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
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
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 (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
- •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 + Placebo
Participants will receive atezolizumab and placebo IV.
干预措施: Placebo (Drug)
Atezolizumab + Tiragolumab
Participants will receive atezolizumab and tiragolumab intravenously (IV).
干预措施: Tiragolumab (Drug)
Atezolizumab + Placebo
Participants will receive atezolizumab and placebo IV.
干预措施: Atezolizumab (Drug)
Atezolizumab + Tiragolumab
Participants will receive atezolizumab and tiragolumab intravenously (IV).
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 16.4 months
An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention.
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)