Non-small Cell Lung CancerPhase 3NCT06545747
Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI
A Phase 3 study testing DCE-MRI based split-course hypo-RT, CT based split-course hypo-RT and Concurrent chemotherapy in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- DCE-MRI based split-course hypo-RT, CT based split-course hypo-RT and Concurrent chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Bo Qiu, MD, 02087343031, qiubo@sysucc.org.cn
About this study
Official title: 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 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:
- The study group will undergo adaptive dose-painting hypo-RT based on DCE-MRI.
- 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
- Being tested
- DCE-MRI based split-course hypo-RT, CT based split-course hypo-RT, Concurrent chemotherapy, Consolidative immunotherapy
- Keywords
- hypo-fractionated radiotherapy, consolidative immunotherapy, MRI-guided
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCE-MRI based split-course hypo-RTRadiation
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.
CT based split-course hypo-RTRadiation
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 chemotherapyDrug
Concurrent Chemotherapy consists of weekly albumin-bound paclitaxel 50mg/m2, d1 plus cisplatin 25mg/m2，d1.
Consolidative immunotherapyDrug
Consolidative PD-1/PD-L1 inhibitors
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: CT based split-course hypo-RT; Drug: Concurrent chemotherapy; Drug: Consolidative immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment-related G2+ respiratory toxicity
the percentage of patients who developed G2+ respiratory toxicity, including pneumonitis and proximal bronchial tree toxicity
Measured: 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
Measured: 2-year
Secondary outcomes (4)
local control rate
Measured: 2-year
overall survival rate
Measured: 2-year
patient reported outcome assessed by QLQ-C30
assessed by QLQ-C30
Measured: 2 year
patient reported outcome
assessed by QLQ-LC13 questionnaires
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Aug 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Liu, Sun Yat-sen University
- Investigators
- Hui Liu, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545747
- Sponsor's protocol ID
- A2024-001
- Status last verified
- Jul 2025
- First submitted
- 4 Aug 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06545747
- Acronym / sponsor ID
- A2024-001
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- hypo-fractionated radiotherapy, consolidative immunotherapy, MRI-guided
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The study group will undergo adaptive dose-painting hypo-RT based on DCE-MRI.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI-based hypo-RT | Experimental | Radiation: DCE-MRI based split-course hypo-RT, Drug: Concurrent chemotherapy, Drug: Consolidative immunotherapyPatients 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. |
| CT-based hypo-RT | Active comparator | Radiation: CT based split-course hypo-RT, Drug: Concurrent chemotherapy, Drug: Consolidative immunotherapyPatients will receive split-course hypo-RT combined with concurrent chemotherapy and consolidative immunotherapy. The control arm will undergo hypo-RT based on CT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCE-MRI based split-course hypo-RTTumor 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. | Radiation | MRI-based hypo-RT |
| CT based split-course hypo-RTTumor 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. | Radiation | CT-based hypo-RT |
| Concurrent chemotherapyConcurrent Chemotherapy consists of weekly albumin-bound paclitaxel 50mg/m2, d1 plus cisplatin 25mg/m2，d1. | Drug | CT-based hypo-RT, MRI-based hypo-RT |
| Consolidative immunotherapyConsolidative PD-1/PD-L1 inhibitors | Drug | CT-based hypo-RT, MRI-based hypo-RT |
Primary outcome
treatment-related G2+ respiratory toxicity
Time frame: Recorded from the enrollment to 1 year after the completion of hypo-RT or 3 months after the completion of consolidative immunotherapy
the percentage of patients who developed G2+ respiratory toxicity, including pneumonitis and proximal bronchial tree toxicity
progression-free survival rate
Time frame: 2-year
4 secondary outcomes
local control rate
Time frame: 2-year
overall survival rate
Time frame: 2-year
patient reported outcome assessed by QLQ-C30
Time frame: 2 year
patient reported outcome
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui Liu principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DCE-MRI based split-course hypo-RT, CT based split-course hypo-RT and Concurrent chemotherapy in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Qiu, MD (02087343031, qiubo@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment-related G2+ respiratory toxicity (time frame: Recorded from the enrollment to 1 year after the completion of hypo-RT or 3 months after the completion of consolidative immunotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.