EUCTR2018-004040-28-BE进行中（未招募）1 期
A Phase Ib/II, Open-Label Study of M7824 in Combination with Chemotherapy in Participants with Stage IV Non-small Cell Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 64
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
- •1. Participants = 18 years of age inclusive at the time of signing the informed consent.
- •2. Are participants who have histologically confirmed diagnosis of Stage IV NSCLC.
- •a. Participants in Cohort A, B, and C must not have received prior systemic therapy treatment for their Stage IV NSCLC.
- •b. Resolution of toxic effects of previous chemotherapy to Grade = 1 must be confirmed prior to enrollment
- •c. Participants who had disease progression on previous 1L treatment with PD (L)1 inhibitors in combination with platinum-based chemotherapy are enrolled in Cohort D.
- •d. Have measurable disease based on RECIST 1.1
- •e. Have a life expectancy of at least 3 months
- •f. Availability of archived tumor material (< 6 months old) adequate for biomarker analysis is mandatory at Screening, central laboratory confirmation is required. Fresh biopsies should be collected if archived tumor material is not available.
- •3. ECOG PS of 0 to 1 at study entry and date of first dose.
- •4. Other criteria may apply.
- •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 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The participant’s tumor harbors an EGFR sensitizing (activating) mutation, ROS1 rearrangement, BRAF V600E Mutation or is ALK positive, if targeted therapy is locally approved.
- •2. Mixed small cell with NSCLC cancer histology.
- •3. Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy (RT) of > 30 Gy within 6 months prior to the first dose of study intervention.
- •4. Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years.
- •5. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks after the end of the RT and have no evidence of new or enlarging brain metastases evaluated by Image, preferably brain MRI.
- •6. Active autoimmune disease that has required systemic treatment in the past 1 year (e.g. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), OR is receiving systemic steroid therapy < 3 days prior to the first dose of study intervention (M7824, cisplatin, carboplatin, pemetrexed, paclitaxel, nab-paclitaxel, gemcitabine, or docetaxel) or receiving any other form of immunosuppressive medication.
- •7. Known severe hypersensitivity to study intervention or any components in their formulations.
- •8. For participants in Cohort A, B and C: Has received prior systemic therapy for Stage IV NSCLC, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •9. Other criteria may apply.
研究者
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