2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China, 310009
NCT Number: NCT05882513
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Hangzhou, China, 310009
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Serplulimab
radical resection of lung cancer
Other names: Surgery
Tumour sample will be collected after surgery
Time frame: 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.
Time frame: 1 month after surgery
In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.
Time frame: before surgery
The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria
Time frame: 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
Time frame: 1 month after surgery
Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0
Time frame: 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
Time frame: 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.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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