NCT07229729招募中2 期
A Randomized, Open-label, Multicenter Phase II Clinical Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Perioperative Treatment of Resectable Non-small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pathology complete response (pCR)
研究概览
简要总结
The study is a Phase II study to explore the efficacy and safety of SHR-A2102 in combination with other anti-tumor therapies as perioperative treatment in patients with resectable non-small cell lung cancer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in writing;
- •Participants must be aged between 18 and 70 years old (inclusive) when signing the informed consent form, and both men and women are eligible;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- •Adequate organ function;
- •Women of childbearing age must undergo serum pregnancy tests, and the results must be negative. Female subjects of childbearing age and male subjects who are partners of women of childbearing age must agree to use highly effective contraceptive methods.
排除标准
- •With active, known or suspected autoimmune disease of autoimmune disease;
- •Malignancies other than NSCLC within 5 years prior to randomization;
- •Has or suspected has a history of pneumonitis / interstitial lung disease or any serve lung diseases which will influence the examination of lung function;
- •Significant history of cardiovascular and cerebrovascular disease; Significant haemorrhagic disease;
- •Has an arteriovenous thrombotic events;
- •Has a known history of human immunodeficiency virus (HIV) infection;
- •Has a known active Hepatitis B or Hepatitis C;
- •Allergic to the intervention regimens.
研究组 & 干预措施
SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group
Experimental
干预措施: Paclitaxel (Drug)
SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group
Experimental
干预措施: Carboplatin (Drug)
SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group
Active Comparator
干预措施: SHR-A2102 (Drug)
SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group
Active Comparator
干预措施: Alomnertinib Mesilate (Drug)
SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group
Active Comparator
干预措施: Furmonertini Mesilate (Drug)
SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group
Experimental
干预措施: Adebrelimab (Drug)
SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group
Experimental
干预措施: SHR-A2102 (Drug)
SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group
Active Comparator
干预措施: Osimertinib Mesylate (Drug)
结局指标
主要结局
Pathology complete response (pCR)
时间窗: Up to approximately 20 weeks.
18-month event free rate
时间窗: Up to approximately 18 months.
2-years disease free rate
时间窗: Up to approximately 2 years.
次要结局
- Event free survival (EFS)(Up to approximately 5 years.)
- Overall survival (OS)(Up to approximately 5 years.)
- Disease-Free Survival (DFS)(Up to approximately 5 years.)
- Objective response rate (ORR)(Up to approximately 20 weeks.)
- Adverse events (AEs)(Up to approximately 5 years.)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
SHR-A2102 Combined With Adebrelimab as Neoadjuvant Therapy for Early Triple-Negative Breast CancerNCT06819319Henan Cancer Hospital52
招募中
2 期
A Trial of SHR-A2102 for Treatment of Advanced Gynecological MalignancyAdvanced Gynecological MalignancyNCT06654440Shanghai Hengrui Pharmaceutical Co., Ltd.100
招募中
2 期
A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid TumorsNCT06895928Shanghai Hengrui Pharmaceutical Co., Ltd.400
招募中
1 期
A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma CancerNCT07059221Suzhou Suncadia Biopharmaceuticals Co., Ltd.210
招募中
1 期
A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung CancerAdvanced or Metastatic Non-small Cell Lung CancerNCT06512051Shanghai Hengrui Pharmaceutical Co., Ltd.248