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

NCT ID: NCT06545747

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 490 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2028-07-31

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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRI-based hypo-RT

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.

Group Type: EXPERIMENTAL

DCE-MRI based split-course hypo-RT

Intervention Type: 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.

Concurrent chemotherapy

Intervention Type: DRUG

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

Consolidative immunotherapy

Intervention Type: DRUG

Consolidative PD-1/PD-L1 inhibitors

CT-based hypo-RT

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

Group Type: ACTIVE_COMPARATOR

CT based split-course hypo-RT

Intervention Type: 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.

Concurrent chemotherapy

Intervention Type: DRUG

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

Consolidative immunotherapy

Intervention Type: DRUG

Consolidative PD-1/PD-L1 inhibitors

Interventions

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.

Intervention Type: 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.

Intervention Type: RADIATION

Concurrent chemotherapy

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

Intervention Type: DRUG

Consolidative immunotherapy

Consolidative PD-1/PD-L1 inhibitors

Intervention Type: DRUG

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Hui Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Liu

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Bo Qiu, MD

Role: CONTACT

qiubo@sysucc.org.cn

02087343031

Facility Contacts

Bo Qiu, MD

Role: primary

qiubo@sysucc.org.cn

02087343031

Other Identifiers

A2024-001

Identifier Type: -

Identifier Source: org_study_id