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A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Therapy in NSCLC

Unresectable Lung Non-Small Cell Carcinoma Clinical Trial

Official title:
A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Treatment for Patients With Stage IIIB-IVA Oligometastatic Non-small Cell Lung Cancer

Clinical Trial Summary

This is a phase II, single-arm study to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer.

Clinical Trial Description

This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer. The primary endpoints were the rate of NSCLC converting to resectable tumors and the 1-year progression-free survival (PFS) rate.The secondary endpoints included the rates of R0 resection, major pathological response (MPR) and pathological complete response (pCR), overall survival (OS) and PFS. Multi-omics analysis will be performed to identify potential biomarkers for treatment response. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05837052
Study type Interventional
Source Zhejiang University
Contact Peng Zhao, MD
Phone +86-18767186629
Email zhaop@zju.edu.cn
Status Recruiting
Phase Phase 2
Start date May 15, 2023
Completion date December 30, 2026
View Details
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