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

NCT ID: NCT05882513

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2030-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lung cancer group

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.

Group Type: EXPERIMENTAL

Serplulimab and neoadjuvant therapy

Intervention Type: 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.

surgical resection of lung cancer

Intervention Type: PROCEDURE

radical resection of lung cancer

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

Intervention Type: OTHER

Tumour sample will be collected after surgery

Interventions

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.

Intervention Type: DRUG

surgical resection of lung cancer

radical resection of lung cancer

Intervention Type: PROCEDURE

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

Tumour sample will be collected after surgery

Intervention Type: OTHER

Other Intervention Names

Serplulimab; Surgery

Eligibility Criteria

Inclusion Criteria

1. signed informed consent;

2. patients age 18 to 75 years old

3. primary resectable, histologically confirmed non small cell lung cancer;

4. non small cell lung cancer the clinical stage was IIA-IIIB (no N3 patient) (according to AJCC TNM stage, 8th edition).

5. ECOG PS 0-1.

6. the diseases could be resectable assessed by thoracic oncologist

Exclusion Criteria

1. with significant cardiovascular disease;

2. current treatment with anti-viral therapy or HBV;

3. Female patients who are pregnant or lactating;

4. history of malignancy within 5 years prior to screening;

5. active or history of autoimmune disease or immune deficiency;

6. signs of distant metastases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weilin Wang

Role: STUDY_CHAIR

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China, China

Countries

China

Other Identifiers

2023-0485

Identifier Type: -

Identifier Source: org_study_id