EUCTR2019-003301-97-DE进行中（未招募）1 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB PLUS CARBOPLATIN AND ETOPOSIDE WITH OR WITHOUT TIRAGOLUMAB (ANTI-TIGIT ANTIBODY) IN PATIENTS WITH UNTREATED EXTENSIVE-STAGE SMALL CELL LUNG CANCER.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 470
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age >= 18 years
- •- Eastern Cooperative Oncology Group performance status of 0 or 1
- •- Histologically or cytologically confirmed ES-SCLC
- •- No prior systemic treatment for ES-SCLC
- •- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1
- •- Adequate hematologic and end-organ function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 220
排除标准
- •- Symptomatic or actively progressing CNS metastases
- •- Leptomeningeal disease
- •- Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- •- 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 on screening chest CT scan
- •- Severe infection at the time of randomization
- •- Treatment with investigational agent within 28 days prior to initiation of treatment study
- •- Current treatment with anti-viral therapy for HBV or HCV
- •- 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 randomization
- •- Treatment with systemic immunosuppressive medications within 1 week prior to randomization or anticipation of need for systemic immunosuppressive medication during study treatment.
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