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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

surgical resection of lung cancer: radical resection of lung cancer

Tumour will be Collected from participant. Fate of sample is Destruction after use: Tumour sample will be collected after surgery

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition