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Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT06545747•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female aged between 18 and 75 years old.
•Patients must have histological or cytological confirmation of locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC).
•No prior radiation therapy or surgery.
•Expected life expectancy of at least 12 weeks.
•World Health Organization (WHO) performance status score of 0 or 1.
•Able to undergo magnetic resonance imaging (MRI) examination.
•Organ and bone marrow function meeting the following criteria: Forced expiratory volume in 1 second (FEV1) ≥ 800 ml; Absolute neutrophil count ≥ 1.5 × 10\^9/L; Platelets ≥ 100 × 10\^9/L; Hemoglobin ≥ 9.0 g/dL; Serum creatinine clearance rate calculated by the Cockcroft-Gault formula ≥ 50 mL/min (Cockcroft and Gault 1976); Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN.

Exclusion Criteria

•Contraindications to MRI examination.
•Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study.
•Histological type of mixed small cell and non-small cell lung cancer.
•Major surgery performed within 4 weeks prior to entering the study (excluding vascular access).
•History or occurrence of autoimmune disease within the past 2 years.
•Active or history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
•History of primary immunodeficiency.
•History of organ transplantation requiring immunosuppressive therapy.
•Average QT interval (QTc) ≥ 470 ms calculated from 3 ECG cycles using Bazett's correction.
•Uncontrolled comorbidities, including but not limited to persistent or active infection, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmia, active peptic ulcer disease or gastritis, active bleeding disorder, human immunodeficiency virus (HIV), or psychiatric/social situations that would limit compliance with study requirements or impair the ability to provide written informed consent.
+4 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, China

Key Dates

Start Date

August 1, 2024

Primary Completion Date

July 31, 2028

Completion Date

July 31, 2028

Last Updated

July 24, 2025

Enrollment

490

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer

Interventions

DCE-MRI based split-course hypo-RT

RADIATION

CT based split-course hypo-RT

RADIATION

Concurrent chemotherapy

DRUG

Consolidative immunotherapy

DRUG

Contacts

Bo Qiu, MD

CONTACT

02087343031 qiubo@sysucc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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