EUCTR2020-004026-31-AT进行中（未招募）1 期
A Phase 2 Randomized Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy as First Line Treatment for Participants with Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
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
- •Males and females; = 18 years of age or local age of majority.
- •Histologically confirmed metastatic NSCLC of squamous (SQ) or non-squamous (NSQ) histology with Stage IV or recurrent disease following multi-modal therapy for locally advanced disease.
- •Measurable disease by computed tomography or magnetic resonance imaging per Response
- •Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization.
- •No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.
- •ECOG PS of less than or equal to 1 at screening and confirmed prior to randomization.
- •Participants must have a life expectancy of at least 3 months at the time of first dose.
- •A formalin-fixed paraffin-embedded tissue block containing enough tissue to cut 20 sections (preferred) or a minimum of 20 unstained slides of tumor tissue from core biopsy, punch
- •biopsy, excisional biopsy, or surgical specimen obtained during screening or prior to enrollment (within 3 months of enrollment if stored at 2-8°C or within 2 months of enrollment if stored at ambient temperature and with no intervening systemic anti-cancer treatment between time of acquisition and enrollment) must be sent to the central laboratory.
- •Participants must have PD-L1 immunohistochemistry (IHC) results from a central laboratory during the screening period prior to randomization.
- •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 156
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 364
排除标准
- •Women who are pregnant or breastfeeding.
- •Participants with EGFR, ALK, or ROS-1 mutations which are sensitive to available targeted inhibitor therapy. All participants with NSQ histology must have been tested for EGFR, ALK, or ROS-1 mutation status. Participants with NSQ histology and unknown EGFR, ALK, or ROS-1 status are excluded.
- •Participants with known BRAFV600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are
- •Participants with untreated central nervous system metastases.
- •Participants with leptomeningeal metastases (carcinomatous meningitis).
- •Concurrent malignancy requiring treatment.
- •Participants with an active, known, or suspected autoimmune disease.
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- •Participants with history of myocarditis.
研究者
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