2023-504038-23-00招募中2 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)
F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG13 个研究点 分布在 2 个国家目标入组 149 人开始时间: 2024年6月27日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 149
- 试验地点
- 13
- 主要终点
- Stage 1 1. Objective response rate (ORR)
研究概览
简要总结
Stage 1 To evaluate the efficacy of immunotherapy-based treatment combinations based on objective response (ORR)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- A Phase Ib/ii, Study Of Multiple Treatment Combinations In Patients With Metastatic Lung Cancer
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
Stage 1 1. Objective response rate (ORR)
Stage 1 1. Objective response rate (ORR)
次要结局
- Stage 1 1. PFS
- Stage 1 2. PFS at specific time points
- Stage 1 3. OS
- Stage 1 4. OS at specific time points
- Stage 1 5. DOR
- Stage 1 6. DCR
- Stage 1 and 2 7. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0
- Stage 1 and 2 8. Change from baseline in vital signs, electrocardiogram parameters and targeted clinical laboratory test results
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (13)
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