NCT07034391招募中2 期
A Phase II Single-Arm Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 6-month PFS rate
研究概览
简要总结
This is an interventional study to explore the efficacy and safety of denosumab combined chemotherapy and anti-PD-1/PD-L1 inhibitor in locally advanced or metastatic NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
- •Documented negative for EGFR/ALK/ROS1/BRAFV600E/RET/METex14 mutations by validated genomic testing, with no prior targeted therapy and no history of other malignancies
- •No previous systemic therapy for advanced/metastatic disease
- •At least one measurable lesion per RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •No use of parathyroid hormone/derivatives, calcitonin, osteoprotegerin, mithramycin, or potassium supplements within the past 6 months
- •Adequate organ and marrow function
排除标准
- •Histologically or cytologically confirmed combined small cell and non-small cell lung cancer (mixed histology)
- •Any previous systemic anticancer treatment for NSCLC, including chemotherapy, biologics, immunotherapy, or investigational agents
- •Prior use of denosumab or any bone-modifying agents (e.g., bisphosphonates)
- •Uncontrolled hypocalcemia or hypophosphatemia
- •History or current evidence of osteonecrosis of the jaw (ONJ) or osteomyelitis of the jaw
研究组 & 干预措施
denosumab combined chemotherapy plus anti-PD-1/PD-L1 inhibitor
Experimental
干预措施: denosumab combined anti-PD-1 inhibitor with chemotherapy (Drug)
结局指标
主要结局
6-month PFS rate
时间窗: 6 months
6-month progression-free rate
次要结局
- progression-free survival（PFS）(24 months)
- overall survival (OS)(24 months)
- objective response rate (ORR)(6 months)
- disease control rate (DCR)(6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(24 months)
研究者
Xiujuan Qu
Chief Physician
China Medical University, China
研究点 (1)
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