An Open-label, Single-center, Phase II Study of Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 37
- 主要终点
- Major Pathological Response (MPR) Rate
研究概览
简要总结
Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of Cadonilimab monotherapy as neoadjuvant therapy for patients with resectable stage II-IIIA squamous cell lung cancer.
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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Have previously untreated and pathologically confirmed resectable Stage II-IIIA Squamous cell lung cancer.
- •Have at least one measurable lesion per RECIST 1.1 assessed by investigator. Have adequate organ function.
排除标准
- •Mixed adenocarcinoma and small cell lung cancer histology. Patients with other active malignancies within 5 years prior to enrollment. Known active autoimmune diseases. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
- •Presence of other uncontrolled serious medical conditions.
研究组 & 干预措施
Cadonilimab
Participants receive two cycles of Cadonilimab as neoadjuvant therapy prior to surgery; followed by surgery; followed by standard adjuvant chemotherapy +/- adjuvant Cadonilimab for 6 months.
干预措施: Cadonilimab (Drug)
结局指标
主要结局
Major Pathological Response (MPR) Rate
时间窗: After surgery (approximately 7 weeks)
defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy
次要结局
- Disease Free Survival (DFS)(Up to approximately 5 years)
- Adverse Events (AEs)(From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment)
- Complete (R0) Resection Rate(After surgery (approximately 7 weeks))
- Pathological Complete Response (pCR) Rate(After surgery (approximately 7 weeks))
- Objective Response Rate (ORR)(At the end of 2 cycles of neoadjuvant therapy (each cycle is 21 days))