EUCTR2019-004773-29-AT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 (cCRT)
- •- At least two prior cycles of platinum-based chemotherapy administered concurrently with RT, 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 cCRT must have been at a total dose of radiation of 60 Gy±10% (54 Gy to 66 Gy) administered by intensitymodulated
- •radiotherapy (preferred) or 3D-conforming technique
- •- No progression during or following concurrent platinum-based CRT
- •- A known programmed death ligand 1 PD-L1 result, 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 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 353
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 455
排除标准
- •- Any history of prior NSCLC and/or any history of prior treatment for NSCLC (patients must be newly diagnosed with unresectable Stage III disease)
- •- NSCLC known to have a mutation in the epidermal growth factor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
- •- 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 cCRT 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
- •- 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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