PACTR202301834998443招募中3 期
A PHASE II/III, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF TIRAGOLUMAB IN COMBINATION WITH ATEZOLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATINVERSUS PEMBROLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED NON-SQUAMOUS NON-SMALL-CELL LUNG CANCER
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 540
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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •-Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
- •-No prior systemic treatment for metastatic non-squamous NSCLC
- •-Known tumor programmed death-ligand 1 (PD-L1) status
- •-Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
- •-Life expectancy >= 12 weeks
- •-Adequate hematologic and end-organ function
- •-Negative human immunodeficiency virus (HIV) test at screening
- •-Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.
排除标准
- •-Mutations in epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene
- •-Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
- •-Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •-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 randomization, with the exception of malignancies with a negligible risk of metastasis or death
- •-Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
- •-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-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- •-Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
- •-Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
- •-Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study
- •-Women who are pregnant, or breastfeeding
- •-Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.
研究者
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