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临床试验/CTIS2023-504038-23-00
CTIS2023-504038-23-00进行中(未招募)1 期

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung) - BO39610

F. Hoffmann-La Roche AG0 个研究点目标入组 314 人开始时间: 2024年6月3日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
314

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 65+(—)
性别
All

入选标准

  • Histologically or cytologically confirmed metastatic, non-squamous or squamous NSCLC, Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing, Stage 1 and 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1, Stage 1 and 2 Negative HIV test at screening, Stage 1 and 2 Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus DNA test at screening, Stage 1 and 2 Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening

排除标准

  • Activating mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) gene rearrangement, Prior allogeneic stem cell or solid organ transplantation, Treatment with systemic immunostimulatory agents within 4 weeks (or 5 half-lives of the drug, whichever is longer) or systemic immunosuppressive medication within 2 weeks prior to study treatment start, History of malignancy other than NSCLC within 2 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death, Active tuberculosis, Severe infection within 4 weeks prior to initiation of study treatment

研究者

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