2023-508083-30-00招募中2 期
A Phase II, Randomized, Blinded, Placebo-Controlled Study of Tiragolumab, an Anti- TIGIT Antibody, in Combination with Atezolizumab in Chemotherapy-Naive Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 47
- 试验地点
- 10
- 主要终点
- 1. ORR as determined by the investigator according to RECIST v1.1
研究概览
简要总结
To evaluate the efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab, as measured by objective response rate (ORR) and progression-free survival (PFS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Follow-up
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •No prior systemic treatment for locally advanced unresectable or metastatic NSCLC
- •Tumor PD-L1 expression on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
- •Confirmed availability of representative tumor specimens, along with an associated pathology report
- •Measurable disease as defined by RECIST v1.1
- •Life expectancy ≥12 weeks
- •Adequate hematologic and end-organ function
排除标准
- •Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
- •Patients with the pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
- •Symptomatic, untreated, or actively progressing CNS metastases
- •Spinal cord compression not definitively treated with surgery and/or radiation
- •History of leptomeningeal disease
- •Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome
结局指标
主要结局
1. ORR as determined by the investigator according to RECIST v1.1
1. ORR as determined by the investigator according to RECIST v1.1
2. PFS as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first
2. PFS as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first
次要结局
- 1. DOR as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first
- 2. Overall survival
- 3. Incidence, nature, and severity of adverse events, graded according to the NCI CTCAE v4.0
- 4. Clinically significant changes from baseline in vital signs, physical findings, and clinical laboratory results
- 5. Serum concentrations of tiragolumab or atezolizumab at specified timepoints
- 6. Incidence of treatment-emergent Anti-drug antibodies (ADAs) and their potential impact on safety, efficacy, and pharmacokinetics
研究者
US Program Manager Product Development Regulatory
Scientific
Genentech Inc.
研究点 (10)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study of MTIG7192A in Combination with Atezolizumab in Chemotherapy-Naive Patients with Locally Advanced or Metastatic Non-Small Cell Lung CancerEUCTR2018-000280-81-PLGenentech, Inc135
进行中（未招募）
1 期
A Study of MTIG7192A in Combination with Atezolizumab in Chemotherapy-Naive Patients with Locally Advanced or Metastatic Non-Small Cell Lung CancerEUCTR2018-000280-81-FRGenentech, Inc135
进行中（未招募）
不适用
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASESPAIN DUE TO BONE METASTASESMedDRA version: 13.1Level: LLTClassification code 10049038Term: Metastatic bone painSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-005181-31-ATPfizer Inc., 235 East 42nd Street, New York, NY 1001758
进行中（未招募）
不适用
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASESPAIN DUE TO BONE METASTASESMedDRA version: 9.1Level: LLTClassification code 10049038Term: Metastatic bone painEUCTR2008-005181-31-HUPfizer Inc., 235 East 42nd Street, New York, NY 1001760
进行中（未招募）
不适用
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASESEUCTR2008-005181-31-LVPfizer Inc., 235 East 42nd Street, New York, NY 1001758