Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer
- Conditions
- NSCLCNeoadjuvant Therapy
- Interventions
- Procedure: surgical resection of lung cancerOther: Tumour will be Collected from participant. Fate of sample is Destruction after use
- Registration Number
- NCT05882513
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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).
- ECOG PS 0-1.
- the diseases could be resectable assessed by thoracic oncologist
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lung cancer group Tumour will be Collected from participant. Fate of sample is Destruction after use 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. Lung cancer group Serplulimab and neoadjuvant therapy 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. Lung cancer group surgical resection of lung cancer 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.
- Primary Outcome Measures
Name Time Method Pathological Complete Response (PCR) 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.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) before surgery The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria
R0 resection rate 1 month after surgery The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope
The changes in the tumor tissue sample among non-PCR (NPCR) and PCR patients 3 month after surgery By using mass spectrometry (CyTOF) and single-cell analysis, we comprehensively characterized the immune landscape in the tumor sample of patients after anti-PD-1 immunotherapy, aiming to explore the immune subsets correlated with neoadjuvant immunotherapy response.
2-year and 5-year overall survival 2-year and 5-year after enrolled The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after enrolled
Major Pathological Response (MPR) 1 month after surgery In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.
Incidence of Treatment-related Adverse Events 1 month after surgery Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0
Trial Locations
- Locations (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, China