EUCTR2017-001267-21-ES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)
F. Hoffman-La Roche Ltd.0 个研究点目标入组 300 人开始时间: 2017年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •- Life expectancy >= 3 months
- •- Histologically or cytologically confirmed metastatic, non-squamous or squamous NSCLC
- •- For patients in Cohort 1: no prior systemic therapy for metastatic NSCLC
- •- For patients in Cohort 2: disease progression during or following treatment for metastatic NSCLC that consisted of a platinum-containing regimen and a Programmed death-ligand 1(PD-L1)/PD-1 checkpoint inhibitor, given in combo as one line of therapy or as two separate lines of therapy for a maximum of two prior lines of systemic therapy
- •- Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing
- •- For patients in Cohort 1: High tumor PD-L1 expression
- •Stage 1 and 2
- •- Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1
- •- Adequate hematologic and end-organ function
- •- Negative HIV, hepatitis B surface antigen test at screening
- •- 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
- •- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- •- Tumor accessible for biopsy
- •- For women of childbearing potential: agreement to remain abstinent or use contraceptive measures as outlined for each specific treatment arm
- •- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
- •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 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 195
排除标准
- •- Activating mutation in the epidermal growth factor receptor gene or anaplastic lymphoma kinase gene rearrangement
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Symptomatic, untreated, or actively progressing central nervous system metastases
- •- 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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