drugset / Trial / NCT05882513

Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer

NCT05882513

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-05-16
Primary completion
2025-12-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Serplulimab Monoclonal antibody 4.5 mg/kg Intravenous
Background Carboplatin Small molecule Intravenous
Background Paclitaxel Small molecule 260 mg/m2
Background Pemetrexed Small molecule 500 mg/m2