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

NCT06545747 | Recruiting Phase 3

• 1 other identifier: A2024-001
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief 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. 1.The study group will undergo adaptive dose-painting hypo-RT based on DCE-MRI.
2. 2.The control group will undergo hypo-RT based on enhanced CT.

Conditions

Non-small Cell Lung Cancer

Keywords

hypo-fractionated radiotherapy; consolidative immunotherapy; MRI-guided

Outcome Measures

Primary Outcomes (2)

• treatment-related G2+ respiratory toxicity

  the percentage of patients who developed G2+ respiratory toxicity, including pneumonitis and proximal bronchial tree toxicity

  Recorded from the enrollment to 1 year after the completion of hypo-RT or 3 months after the completion of consolidative immunotherapy

• progression-free survival rate

  2-year

Secondary Outcomes (4)

• local control rate

  2-year

• overall survival rate

  2-year

• patient reported outcome assessed by QLQ-C30

  2 year

• patient reported outcome

  2 year

Study Arms (2)

MRI-based hypo-RT

EXPERIMENTAL

Patients will receive split-course hypo-RT combined with concurrent chemotherapy and consolidative immunotherapy. The experimental arm will undergo adaptive dose-painting hypo-RT based on DCE-MRI.

Radiation: DCE-MRI based split-course hypo-RT; Drug: Concurrent chemotherapy; Drug: Consolidative immunotherapy

CT-based hypo-RT

ACTIVE COMPARATOR

Patients will receive split-course hypo-RT combined with concurrent chemotherapy and consolidative immunotherapy. The control arm will undergo hypo-RT based on CT.

Radiation: CT based split-course hypo-RT; Drug: Concurrent chemotherapy; Drug: Consolidative immunotherapy

Interventions

DCE-MRI based split-course hypo-RT RADIATION

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.

MRI-based hypo-RT

CT based split-course hypo-RT RADIATION

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.

CT-based hypo-RT

Concurrent chemotherapy DRUG

Concurrent Chemotherapy consists of weekly albumin-bound paclitaxel 50mg/m2, d1 plus cisplatin 25mg/m2，d1.

CT-based hypo-RT; MRI-based hypo-RT

Consolidative immunotherapy DRUG

Consolidative PD-1/PD-L1 inhibitors

CT-based hypo-RT; MRI-based hypo-RT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hui Liu

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Qiu, MD

CONTACT

02087343031; qiubo@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)