JPRN-jRCT2080225327已完成3 期
A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation (SKYSCRAPER-03)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •- Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
- •- Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (CRT)
- •- At least two prior cycles of platinum-based chemotherapy concurrent with radiotherapy (cCRT), which must be completed within 1 to 42 days prior to randomization in the study
- •- The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (+- 10 percent [%]) gray (Gy) (54 Gy to 66 Gy)
- •- No progression during or following concurrent platinum-based CRT
- •- Tumor PD-L1 expression
- •- Life expectancy >/= 12 weeks
- •- Adequate hematologic and end-organ function
排除标准
- •- Any history of prior NSCLC
- •- NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
- •- Any evidence of Stage IV disease
- •- Treatment with sequential CRT for locally advanced NSCLC
- •- Participants with locally advanced NSCLC who have progressed during or after the definitive concurrent CRT prior to randomization
- •- Any Grade >2 unresolved toxicity from previous CRT
- •- Grade >= 2 pneumonitis from prior CRT
- •- 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
- •- History of malignancy other than NSCLC within 5 years prior to screening
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
- •- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- •- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
- •- Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents
- •- Treatment with systemic immunosuppressive medication
研究者
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