A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer
概览
- 阶段
- 2 期
- 干预措施
- Serplulimab and neoadjuvant therapy
- 疾病 / 适应症
- NSCLC
- 发起方
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pathological Complete Response (PCR)
- 状态
- 进行中（未招募）
- 最后更新
- 8天前
概览
简要总结
China with high incidence of non-small cell lung cancer. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of lung cancer patients was not significantly decreased. For patients with locally advanced lung cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of lung cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced lung cancer. However, in patients with locally advanced lung cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of serplulimab combined with chemotherapy in the neoadjuvant therapy of resectable non-small cell lung cancer.
研究者
入排标准
入选标准
- •signed informed consent;
- •patients age 18 to 75 years old
- •primary resectable, histologically confirmed non small cell lung cancer;
- •non small cell lung cancer the clinical stage was IIA-IIIB (no N3 patient) (according to AJCC TNM stage, 8th edition).
- •the diseases could be resectable assessed by thoracic oncologist
排除标准
- •with significant cardiovascular disease;
- •current treatment with anti-viral therapy or HBV;
- •Female patients who are pregnant or lactating;
- •history of malignancy within 5 years prior to screening;
- •active or history of autoimmune disease or immune deficiency;
- •signs of distant metastases.
研究组 & 干预措施
Lung cancer group
Squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1; albumin paclitaxel 260mg/m2, day1; carboplatin AUC=5, i.v, day1. Non-squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1 ; pemetrexed 500mg/m2, day1 ; carboplatin AUC=5, i.v, day1. Preoperative neoadjuvant therapy for 3 cycles, one cycle every 21 days. Surgical resection of lung cancer will be arranged about 4-8 weeks after the last cycle of neoadjuvant therapy.
干预措施: Serplulimab and neoadjuvant therapy
Lung cancer group
Squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1; albumin paclitaxel 260mg/m2, day1; carboplatin AUC=5, i.v, day1. Non-squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1 ; pemetrexed 500mg/m2, day1 ; carboplatin AUC=5, i.v, day1. Preoperative neoadjuvant therapy for 3 cycles, one cycle every 21 days. Surgical resection of lung cancer will be arranged about 4-8 weeks after the last cycle of neoadjuvant therapy.
干预措施: surgical resection of lung cancer
Lung cancer group
Squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1; albumin paclitaxel 260mg/m2, day1; carboplatin AUC=5, i.v, day1. Non-squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1 ; pemetrexed 500mg/m2, day1 ; carboplatin AUC=5, i.v, day1. Preoperative neoadjuvant therapy for 3 cycles, one cycle every 21 days. Surgical resection of lung cancer will be arranged about 4-8 weeks after the last cycle of neoadjuvant therapy.
干预措施: Tumour will be Collected from participant. Fate of sample is Destruction after use
结局指标
主要结局
Pathological Complete Response (PCR)
时间窗: 1 month after surgery
No residual invasive tumor cells were found in the pathological examination of resected specimens,including the primary tumor and lymph nodes.
次要结局
- Objective Response Rate (ORR)(before surgery)
- R0 resection rate(1 month after surgery)
- The changes in the tumor tissue sample among non-PCR (NPCR) and PCR patients(3 month after surgery)
- 2-year and 5-year overall survival(2-year and 5-year after enrolled)
- Major Pathological Response (MPR)(1 month after surgery)
- Incidence of Treatment-related Adverse Events(1 month after surgery)