NCT05882513

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

Active, enrolled Phase 2 Last updated 2 December 2025

What this trial tests

Phase 2 trial testing Serplulimab and neoadjuvant therapy in NSCLC in 36 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 May 2023

Primary endpoint
31 December 2025

31 December 2030

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	16 May 2023
Primary completion	31 December 2025
Estimated completion	31 December 2030
Sites	1 location across China

Drugs / interventions tested

• Serplulimab and neoadjuvant therapy — full drug profile →
• surgical resection of lung cancer
• Tumour will be Collected from participant. Fate of sample is Destruction after use

Conditions studied

• NSCLC — all drugs for NSCLC →
• Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 75, any sex, with NSCLC or Neoadjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advancing neoadjuvant therapies in resectable non-small cell lung cancer: implications for novel treatment strategies and biomarker discovery.
   Jeon H, Gor R, D'Aiello A, Stiles B, et al · · 2024 · cited 1× · PMID 38957347 · DOI 10.3389/pore.2024.1611817
2. Conversion therapy with immunotherapy plus chemotherapy achieves a pathological complete response in stage IIIC NSCLC.
   Fu Y, Duan W, Xu R, Chen J. · · 2023 · cited 1× · PMID 38022567 · DOI 10.3389/fimmu.2023.1268153