A Phase III Trial of Neoadjuvant Sintilimab and Chemotherapy for NSCLC Harboring No Driver Mutations

NSCLC, Stage IIIA Clinical Trial

Official title: Neoadjuvant Sintilimab and Platinum-based Chemotherapy for Resectable Locally Advanced NSCLC Harboring no Driver Mutations: A Prospective, Randomized, Multicenter Phase III Trial

Status Recruiting

Clinical Trial Summary

This is a randomized, open-label study designed to evaluate the safety and efficacy of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA non-small cell lung cancer.

The primary endpoint: pCR rate The second endpoint: MPR, DFS, MRD

Clinical Trial Description

This study is a prospective, multicenter, phase III randomized controlled clinical study. Stage IIIA NSCLC patients with EGFR mutation negative and ALK rearrangement negative were enrolled, and after 2 courses of treatment with Sintilimab combined with Platinum-based Chemotherapy, they were randomly assigned 1:1 to the control group (surgical resection and postoperative treatment for 2 courses are recommended) or the experimental group (surgery after 2 courses of treatment).

The primary endpoint is pCR rate. The second endpoints are MPR, DFS, and MRD. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC, Stage IIIA

• NCT number: NCT05157776
• Study type: Interventional
• Source: Tongji University
• Contact: Jiang Fan, MD
• Phone: 15901013210
• Email: fan_jiang@tongji.edu.cn
• Status: Recruiting
• Phase: Phase 3
• Start date: October 28, 2021
• Completion date: October 31, 2025