2022-502482-17-00进行中（未招募）3 期
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
- 进行中（未招募）
- 入组人数
- 192
- 试验地点
- 26
- 主要终点
- 1. PFS as determined by the investigator according to RECIST v1.1 in the primary analysis population
研究概览
简要总结
- To evaluate the efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab on the basis of the progression-free survival (PFS) and overall survival (OS) in the primary analysis population
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Subject, Carer, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years and Eastern Cooperative Oncology Group Performance Status of 0 or
- •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.
- •Tumor PD-L1 expression as determined by PD-L1 IHC assay TPS >= 50% as determined by 22C3 pharmaDx assay TC3 or IC3 as determined by the VENTANA PD-L1 Assay (SP142), or TC >= 50% as determined by the investigational VENTANA PD-L1 CDx Assay (SP263) of tumor tissue.
- •Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
- •Adequate hematologic and end-organ function.
排除标准
- •Known mutation in the EGFR gene or an ALK fusion oncogene.
- •Symptomatic, untreated, or actively progressing central nervous system metastases.
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis.
- •History of malignancies other than NSCLC within 5 years, with the exception of malignancies with a negligible risk of metastasis or death treated with expected curative outcome.
- •Positive test result for human immunodeficiency virus (HIV). Active hepatitis B or hepatitis C infection.
- •Treatment with investigational therapy within 28 days prior to initiation of study treatment. Prior treatment with CD137 agonists or immune checkpoint blockade therapies. Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.
结局指标
主要结局
1. PFS as determined by the investigator according to RECIST v1.1 in the primary analysis population
1. PFS as determined by the investigator according to RECIST v1.1 in the primary analysis population
2. Overall Survival (OS) in the primary analysis population
2. Overall Survival (OS) in the primary analysis population
次要结局
- 11. Prevalence of ADAs to tiragolumab at baseline and incidence of ADAs to tiragolumab during the study
- 12. Prevalence of ADAs to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study
- 1. Investigator assessed PFS according to RECIST v1.1 in the secondary analysis population
- 2. OS in the secondary analysis population
- 3. Confirmed ORR as determined by the investigator according to RECIST v1.1
- 4. DOR for patients with confirmed ORR as determined by the investigator according to RECIST v1.1
- 5. PFS rate at 6 months and 12 months as determined by the investigator according to RECIST v1.1
- 6. OS rate at 12 months and 24 months
- 7. Time to confirmed deterioration (TTCD) in patient-reported physical functioning and global health status/quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer
- 8. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0
- 9. Severity for CRS will also be determined according to the ASTCT CRS consensus grading scale
- 10. Serum concentrations of tiragolumab and atezolizumab at specified timepoints
- 13. Change in EQ-5D-5L index-based and visual analog scale (VAS) scores at specified timepoints during the study (including post-progression)
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (26)
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