NCT06924606终止2 期
A Phase II Study of JS207 (PD-1/VEGF Dual Antibody) in Combination With or Without JS004 or Docetaxel in Advanced Non-small Cell Lung Cancer With Disease Progression During or After the Treatment of Platinum-based Chemotherapy and Immunotherapy
Shanghai Junshi Bioscience Co., Ltd.46 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年7月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 46
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 (stage IIIB/IIIC) NSCLC that is not amenable to radical surgery or radical radiochemotherapy, or Metastatic or recurrent NSCLC.
- •Subjects with unresectable locally advanced or metastatic or recurrent NSCLC who have failed first-line treatment with PD-1/PD-L1 inhibitors combined with platinum-based doublet chemotherapy (excluding docetaxel); or who have failed sequential first- and second-line treatment with PD-1/PD-L1 inhibitors followed by platinum-based doublet chemotherapy (excluding docetaxel).
- •Subjects must have at least one measurable lesion according to RECIST v1.1.
排除标准
- •Histopathologically or cytopathologically confirmed to have combined neuroendocrine component.
- •Sensitivity mutation of EGFR or ALK fusion.
- •Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.
研究组 & 干预措施
Arm A
Experimental
Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.
干预措施: JS207 injection +docetaxel (Drug)
Arm B
Experimental
Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.
干预措施: JS207 injection +JS004 injection (Drug)
Arm C
Experimental
Patients receive JS207 10mg/kg or other dosage .
干预措施: JS207 injection (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 1.5years
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR)
次要结局
- Duration of response (DOR)(2years)
- Overall survival (OS)(2years)
- Disease control rate (DCR)(2years)
- Progression-free survival (PFS)(1.5years)
- AE(2years)
- Abnormal changes in laboratory(2years)
研究者
研究点 (46)
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