NCT06545747

Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI

A Randomized Controlled Phase III Study of Adaptive Hypofractionated Radiotherapy Combined With Concurrent Chemotherapy and Consolidative Immunotherapy in Locally Advanced Non-Small Cell Lung Cancer Based on Dynamic Enhanced Magnetic Resonance Imaging

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 490 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized phase III trial that aiming to investigate the role of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) guided hypofractionated radiotherapy (hypo-RT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who are planned to receive hypo-RT combined with concurrent chemotherapy and consolidative immunotherapy. Patients will be randomized in a 1:1 ratio into two groups: 1. The study group will undergo adaptive dose-painting hypo-RT based on DCE-MRI. 2. The control group will undergo hypo-RT based on enhanced CT. The treatment-related toxicity, local control and long-term survival will be evaluated compared between MRI-guided and CT-guided hypo-RT.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	DCE-MRI based split-course hypo-RT	Tumor delineation will be based on DCE-MRI and CT. MRI help define the tumor boundary. Different radiation doses will be delivered based on the Ktrans value of the tumor area on DCE-MRI.
RADIATION	CT based split-course hypo-RT	Tumor delineation will be based on CT. The total dose for both the first and boost courses of hypo-RT to the tumor area will be constant.
DRUG	Concurrent chemotherapy	Concurrent Chemotherapy consists of weekly albumin-bound paclitaxel 50mg/m2, d1 plus cisplatin 25mg/m2，d1.
DRUG	Consolidative immunotherapy	Consolidative PD-1/PD-L1 inhibitors

Timeline

• Start date: 2024-08-01
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2024-08-09
• Last updated: 2026-04-06

Locations

1 site across 1 country: China