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NCT Number: NCT05882513

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China, 310009

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • with significant cardiovascular disease;
  • current treatment with anti-viral therapy or HBV;
  • Female patients who are pregnant or lactating;
  • history of malignancy within 5 years prior to screening;
  • active or history of autoimmune disease or immune deficiency;
  • signs of distant metastases.

Treatment and study plan

Serplulimab and neoadjuvant therapy

Drug

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

surgical resection of lung cancer

Procedure

radical resection of lung cancer

Other names: Surgery

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

Other

Tumour sample will be collected after surgery

Primary outcomes

  1. Pathological Complete Response (PCR)

    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.

Secondary outcomes

  1. Major Pathological Response (MPR)

    Time frame: 1 month after surgery

    In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.

  2. Objective Response Rate (ORR)

    Time frame: before surgery

    The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria

  3. 2-year and 5-year overall survival

    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

  4. Incidence of Treatment-related Adverse Events

    Time frame: 1 month after surgery

    Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0

  5. R0 resection rate

    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

  6. The changes in the tumor tissue sample among non-PCR (NPCR) and PCR patients

    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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
May 31, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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