Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung cancer group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab and neoadjuvant therapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (PCR) | No residual invasive tumor cells were found in the pathological examination of resected specimens,including the primary tumor and lymph nodes. | 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response (MPR) | In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%. | 1 month after surgery |
| Objective Response Rate (ORR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Weilin Wang | 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | China | 310009 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| surgical resection of lung cancer | Procedure | radical resection of lung cancer |
|
|
| Tumour will be Collected from participant. Fate of sample is Destruction after use | Other | Tumour sample will be collected after surgery |
|
The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria
| before surgery |
| 2-year and 5-year overall survival | The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after enrolled | 2-year and 5-year after enrolled |
| Incidence of Treatment-related Adverse Events | Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0 | 1 month after surgery |
| R0 resection rate | The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope | 1 month after surgery |
| The changes in the tumor tissue sample among non-PCR (NPCR) and PCR patients | 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. | 3 month after surgery |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
Not provided
Not provided