NL-OMON54439招募中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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 21
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
- 18 至 99（—）
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 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
- •radio therapy (cCRT), which must be completed within 1 to 42 days prior to
- •randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
- •- 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 means of central testing of a
- •representative tumor tissue, in either a previously obtained archival tumor
- •tissue or fresh tissue obtained from a biopsy collected prior to the first dose
- •- 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 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 - Severe
- •infection within 4 weeks prior to initiation of study treatment, including, but
- •not limited to, hospitalization for complications of infection, bacteremia, or
- •severe pneumonia, or any active infection that, in the opinion of the
- •investigator, could impact patient safety - 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 - 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.
研究者
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