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

NCT05882513 | Active Not Recruiting Phase 2

• 1 other identifier: 2023-0485
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC; Neoadjuvant Therapy

Keywords

serplulimab; Non small cell lung cancer; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (PCR)

  No residual invasive tumor cells were found in the pathological examination of resected specimens,including the primary tumor and lymph nodes.

  1 month after surgery

Secondary Outcomes (6)

• Major Pathological Response (MPR)

  1 month after surgery

• Objective Response Rate (ORR)

  before surgery

• 2-year and 5-year overall survival

  2-year and 5-year after enrolled

• Incidence of Treatment-related Adverse Events

  1 month after surgery

• R0 resection rate

  1 month after surgery

Study Arms (1)

Lung cancer group

EXPERIMENTAL

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. Preoperative neoadjuvant therapy for 3 cycles, one cycle every 21 days. Surgical resection of lung cancer will be arranged about 4-8 weeks after the last cycle of neoadjuvant therapy.

Drug: Serplulimab and neoadjuvant therapy; Procedure: surgical resection of lung cancer; Other: Tumour will be Collected from participant. Fate of sample is Destruction after use

Interventions

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.

Also known as: Serplulimab

Lung cancer group

surgical resection of lung cancer PROCEDURE

radical resection of lung cancer

Also known as: Surgery

Lung cancer group

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

Tumour sample will be collected after surgery

Lung cancer group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China, 310009, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Neoadjuvant Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Weilin Wang

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: May 31, 2023
• Study Start: May 16, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 24, 2026

Record last verified: 2025-11

Locations

CN (1)