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

NSCLC Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882513
• Other study ID #: 2023-0485
• Status: Recruiting
• Phase: Phase 2
• Start date: May 16, 2023
• Est. completion date: May 31, 2030

Study information

• Verified date: May 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Ming Wu
• Phone: +8613757118715
• Email: iwuming22[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: May 31, 2030
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoadjuvant Therapy
• NSCLC

Intervention

Drug:
• 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.

Procedure:
• surgical resection of lung cancer
radical resection of lung cancer

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response (PCR)	No residual invasive tumor cells were found in the pathological examination of resected specimens.	1 month after surgery
Secondary	Major Pathological Response (MPR)	In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.	1 month after surgery
Secondary	Objective Response Rate (ORR)	The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria	before surgery
Secondary	2-year and 5-year overall survival	The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after surgery	2-year and 5-year after surgery
Secondary	Incidence of Treatment-related Adverse Events	Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0	1 month after surgery
Secondary	R0 resection rate	The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope	1 month after surgery