A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR) Rate
研究概览
简要总结
AK104, 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 AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA 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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
- •Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
- •Have adequate organ function.
排除标准
- •Mixed NSCLC and small cell lung cancer histology.
- •Patients with other active malignancies within 3 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
AK104+albumin-bound paclitaxel+carboplatin
Participants receive 3 cycles of AK104 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy prior to surgery; followed by surgery; followed by adjuvant AK104 for 9 cycles.
干预措施: AK104 (Drug)
AK104+albumin-bound paclitaxel+carboplatin
Participants receive 3 cycles of AK104 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy prior to surgery; followed by surgery; followed by adjuvant AK104 for 9 cycles.
干预措施: Albumin-Bound Paclitaxel (Drug)
AK104+albumin-bound paclitaxel+carboplatin
Participants receive 3 cycles of AK104 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy prior to surgery; followed by surgery; followed by adjuvant AK104 for 9 cycles.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Pathological Complete Response (pCR) Rate
时间窗: At time of surgery
defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
次要结局
- Objective Response Rate (ORR)(At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days))
- Event Free Survival (EFS)(Up to approximately 5 years)
- Major Pathological Response (MPR) Rate(At time of surgery)
- Incidence of Surgical Complications(Up to approximately 30 days following surgery)
- Complete (R0) Resection Rate(After surgery (approximately 7 weeks))
- Adverse Events (AEs)(From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment)
研究者
Huijuan Wang
chief physician
Henan Cancer Hospital