Phase II Clinical Study of AK112, an Anti-PD-1 and VEGF Bispecific Antibody, Alone or in Combination With Chemotherapy for the Neoadjuvant/Adjuvant Treatment of Resectable Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Rate of surgical delays
研究概览
简要总结
AK112, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable NSCLC
详细描述
Phase II clinical study of AK112, an anti-PD-1 and VEGF bispecific antibody, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable non-small cell lung cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •18 to 75 years old
- •Be able and willing to provide written informed consent and to comply with all requirements of study participation
- •Histologically confirmed resectable stage II-IIIB NSCLC
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Has adequate organ function
- •All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
排除标准
- •Is currently participating in a study of an investigational agent or using an investigational device
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years
- •Has an active infection requiring systemic therapy
- •Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
- •Has received a live virus vaccine within 30 days prior to first dose of study treatment
- •Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.
研究组 & 干预措施
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)
Neoadjuvant therapy was 3-4 cycles of AK112 plus Carboplatin/cisplatin + paclitaxel(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
干预措施: Cisplatin (Drug)
arm 1(AK112)
Neoadjuvant therapy was 3-4 cycles of AK112(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
干预措施: AK112 (Drug)
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)
Neoadjuvant therapy was 3-4 cycles of AK112 plus Carboplatin/cisplatin + paclitaxel(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
干预措施: AK112 (Drug)
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)
Neoadjuvant therapy was 3-4 cycles of AK112 plus Carboplatin/cisplatin + paclitaxel(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
干预措施: Paclitaxel (Drug)
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)
Neoadjuvant therapy was 3-4 cycles of AK112 plus Carboplatin/cisplatin + paclitaxel(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
干预措施: Carboplatin (Drug)
结局指标
主要结局
Rate of surgical delays
时间窗: Up to approximately 2 years
Proportion of subjects exceeding the maximum surgical time window
Abnormal laboratory findings of clinical significance
时间窗: Up to approximately 2 years
Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests, thyroid function tests, routine urine tests, pregnancy tests, etc.
Major pathological response (MPR)
时间窗: Up to approximately 2 years
Proportion of subjects with ≤10% residual live tumor cells in resected primary tumor and lymph nodes
Incidence and severity of adverse events (AE)
时间窗: Up to approximately 2 years
Summary of AE incidence; summary after grading of AE according to NCI CTCAE version 5.0
次要结局
- Pathological complete response (pCR)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Event free survival (EFS)(Up to approximately 2 years)
- Objective response rate (ORR)(Up to approximately 2 years)
- R0 resection rate(Up to approximately 2 years)
- Tumor descending stage rate(Up to approximately 2 years)