NCT05157776

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Tongji University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• NSCLC, Stage IIIA
• EGF-R Negative Non-Small Cell Lung Cancer
• ALK Negative NSCLC

Interventions

Type	Name	Description
DRUG	PD-1 and chemotherapy	Sintilimab+(Squamous)ABX+DDP/CBP, or (non-Squamous)PEM+DDP/CBP

Timeline

• Start date: 2021-10-28
• Primary completion: 2024-10-31
• Completion: 2025-10-31
• First posted: 2021-12-15
• Last updated: 2023-05-09

Locations

1 site across 1 country: China