NL-OMON56032已完成2 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) - CA224-104 study in participants with Stage IV or Recurrent NSCLC
Bristol-Myers Squibb0 个研究点目标入组 13 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
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 64（—）
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
- •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; please see study Laboratory Manual for specific
- •guidance) 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.
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 eligible.
- •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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