Neoadjuvant Therapy, NSCLC
Conditions
Keywords
serplulimab, Non small cell lung cancer, Neoadjuvant Therapy
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.
Interventions
DRUGSerplulimab 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.
PROCEDUREsurgical resection of lung cancer
radical resection of lung cancer
OTHERTumour will be Collected from participant. Fate of sample is Destruction after use
Tumour sample will be collected after surgery
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. signed informed consent; 2. patients age 18 to 75 years old 3. primary resectable, histologically confirmed non small cell lung cancer; 4. non small cell lung cancer the clinical stage was IIA-IIIB (no N3 patient) (according to AJCC TNM stage, 8th edition). 5. ECOG PS 0-1. 6. the diseases could be resectable assessed by thoracic oncologist
Exclusion criteria
1. with significant cardiovascular disease; 2. current treatment with anti-viral therapy or HBV; 3. Female patients who are pregnant or lactating; 4. history of malignancy within 5 years prior to screening; 5. active or history of autoimmune disease or immune deficiency; 6. signs of distant metastases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
| Objective Response Rate (ORR) | before surgery | The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria |
| 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 |
| Incidence of Treatment-related Adverse Events | 1 month after surgery | Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0 |
| 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. |
Countries
China
Contacts
STUDY_CHAIRWeilin Wang
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed