EUCTR2020-002853-11-NL进行中（未招募）1 期
A PHASE II, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF NEOADJUVANT AND ADJUVANT TIRAGOLUMAB PLUS ATEZOLIZUMAB, WITH OR WITHOUT PLATINUM-BASED CHEMOTHERAPY, IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED RESECTABLE STAGE II, IIIA, OR SELECT IIIB NON-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
- 82
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
- •Histologically or cytologically confirmed Stage II, IIIA, or select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology;
- •Eligible for R0 resection with curative intent at the time of screening, as confirmed by the operating attending surgeon and involved medical oncologist prior to study enrollment;
- •Adequate pulmonary function to be eligible for surgical resection;
- •Measurable disease, as assessed by the investigator per RECIST v1.1;
- •Adequate tumor tissue for PD-L1 assessment;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •Adequate hematologic and end-organ function;
- •Negative HIV test at screening;
- •Negative for active hepatitis B and hepatitis C at screening.
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •NSCLC with histology of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC not otherwise specified;
- •Small cell lung cancer (SCLC) histology or NSCLC with any component of SCLC;
- •Any prior therapy for lung cancer;
- •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;
- •NSCLC with an activating EGFR mutation or ALK fusion oncogene;
- •Known c-ros oncogene 1 (ROS1) rearrangement;
- •History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death;
- •Severe infection within 4 weeks prior to initiation of study treatment;
- •Treatment with investigational therapy within 42 days prior to initiation of study treatment;
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic antibodies;
- •Pregnant or lactating women.
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