NCT05882513Active, not recruitingPhase 2
Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 22 May 2023
- Start date
- 16 May 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Lung cancer
- NCT number
- NCT05882513
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 36
- From 16 May 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current treatment with anti-viral therapy or HBV;
Other illness
- with significant cardiovascular disease;
- history of malignancy within 5 years prior to screening;
- active or history of autoimmune disease or immune deficiency;
Other
- Female patients who are pregnant or lactating;
- signs of distant metastases.
Who the study is looking for
- signed informed consent;
- patients age 18 to 75 years old
- primary resectable, histologically confirmed non small cell lung cancer;
- non small cell lung cancer the clinical stage was IIA-IIIB (no N3 patient) (according to AJCC TNM stage, 8th edition).
- ECOG PS 0-1.
- the diseases could be resectable assessed by thoracic oncologist
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.