EUCTR2019-004773-29-IT进行中（未招募）1 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
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
- 800
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 documented NSCLC with locally advanced unresectable Stage III NSCLC of either squamous or non-squamous histology
- •- Whole-body positron emission tomography (PET)-CT scan for the purposes of staging, 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 RT (CRT), which must be completed within 1 to 42 days prior to randomization in the study
- •- The RT component in the CRT must have been at a total dose of radiation of 60 Gy±10% (54 Gy to 66 Gy) administered by intensity-modulated radiotherapy (preferred) or 3D-conforming technique
- •- No progression during or following concurrent platinum-based CRT
- •- Tumor PD-L1 expression, as determined by the investigational Ventana PD-L1 (SP263) CDx assay and documented by central testing of tissue collected prior to the first dose of cCRT
- •- 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 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 138
排除标准
- •- Any history of prior NSCLC
- •- NSCLC known to have a mutation in the epidermal growth factor mutation and/or an anaplastic lymphoma kinase translocation
- •- Any evidence of Stage IV disease
- •- Treatment with sequential CRT for locally advanced NSCLC
- •- Patients 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
- •- 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
- •- 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
- •- Current treatment with anti-viral therapy for hepatitis B virus or hepatitis C virus
- •- Active EBV infection or known or suspected chronic active EBV infection at Screening
- •- 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-PD-1, and anti-PD-L1 therapeutic antibodies
- •- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-[antiTNF-alpha]agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressivemedication during study treatment.
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