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NCT06545747RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 6 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
490 (estimated)
First submitted
4 Aug 2024
Start date
1 Aug 2024
Primary completion date
31 Jul 2028
Lead sponsor
Sun Yat-sen University
Diseases
Lung cancer
NCT number
NCT06545747

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 490
  • From 1 Aug 2024 to the primary completion date, 31 Jul 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study.
  • Major surgery performed within 4 weeks prior to entering the study (excluding vascular access).
  • Receipt of a live attenuated vaccine within 30 days prior to the start of the study.

Other illness

  • Histological type of mixed small cell and non-small cell lung cancer.
  • 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.
  • 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.
  • Active tuberculosis.
  • History of another primary malignancy within 5 years, excluding adequately treated basal or squamous cell skin cancer or in situ cervical cancer.

Lab values

  • The presence of sensitive EGFR mutations or ALK rearrangements.
  • Average QT interval (QTc) ≥ 470 ms calculated from 3 ECG cycles using Bazett's correction.

Other

  • Contraindications to MRI examination.
  • Pregnant or breastfeeding women; or males and females of reproductive potential not using effective contraception.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.