Adaptive hypofractionated radiotherapy for advanced lung cancer using MRI guidance
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
This study is testing whether using MRI to guide a specific type of radiation therapy can help people with advanced lung cancer do better than using traditional CT guidance.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 490 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | radiation, chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT06545747 on ClinicalTrials.gov |
What this trial studies
This phase III trial investigates the effectiveness of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in guiding hypofractionated radiotherapy for patients with locally advanced non-small cell lung cancer (LA-NSCLC). Participants will be randomly assigned to receive either MRI-guided or CT-guided hypofractionated radiotherapy, combined with concurrent chemotherapy and consolidative immunotherapy. The study aims to evaluate treatment-related toxicity, local control, and long-term survival outcomes between the two groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with unresectable stage III non-small cell lung cancer who can undergo MRI.
Not a fit: Patients with contraindications to MRI or those who have received prior radiation therapy or surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment precision and outcomes for patients with locally advanced lung cancer.
How similar studies have performed: Other studies have shown promise with MRI-guided therapies, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * The presence of sensitive EGFR mutations or ALK rearrangements. * 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. * Active tuberculosis. * Receipt of a live attenuated vaccine within 30 days prior to the start of the study. * History of another primary malignancy within 5 years, excluding adequately treated basal or squamous cell skin cancer or in situ cervical cancer. * Pregnant or breastfeeding women; or males and females of reproductive potential not using effective contraception.
Where this trial is running
Guangzhou
- Sun Yat-sen University Cancer Center — Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Hui Liu — Sun Yat-sen University
- Study coordinator: Bo Qiu, MD
- Email: qiubo@sysucc.org.cn
- Phone: 02087343031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.