Radiation-induced LymphopeniaNCT07564089
Thymus Dosimetric and Morphologic Predictors of Radiation-Induced Lymphopenia in Stage III NSCLC
An observational study of Radiation-induced Lymphopenia and Thymus Dosimetric, run by You Peimeng at 1 site in China.
Trial summary
This study is being done to find out whether features of the thymus gland can predict a common side effect of radiation therapy for lung cancer called radiation-induced lymphopenia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation-induced Lymphopenia, Thymus Dosimetric, Number of Lymphocytes
- What is being tested?
- Definitive Thoracic Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 28 Feb 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This observational study will enroll adult patients with stage III non-small cell lung cancer (NSCLC) who are scheduled to receive definitive thoracic radiotherapy (with or without concurrent/sequential chemotherapy) at participating oncology centers. Patients are identified consecutively from radiation oncology departments during routine pre-radiotherapy planning visits. No experimental treatment or randomization is applied. The study population includes both treatment-naïve patients and those who may have received prior systemic therapy as long as they have not undergone prior thoracic radiotherapy or have persistent grade ≥3 lymphopenia at baseline. The target sample size is determined based on event-per-variable criteria. Both inpatients and outpatients are eligible. Recruitment is performed prospectively over an estimated period of 18-24 months. All enrolled patients must meet the full eligibilit.
Who may be able to join
- Age ≥ 18 years;
- Pathologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) with a clinical stage of III (according to the 8th edition or latest version of the AJCC staging system);
- Eligible for radical radiotherapy or chemoradiotherapy to the chest, with a planned total dose of ≥50 Gy to the chest, using a fractionation schedule of 1.8-2.0 Gy per fraction (conventional fractionation) or a high-dose fractionation regimen permitted by the protocol;
- Planned to undergo periodic blood tests before and after radiotherapy, including absolute lymphocyte count;
- ECOG performance status of 0-2;
- Able to undergo regular follow-up and provide blood samples and imaging evaluations as required by the protocol.
Who cannot join
- Previous history of thoracic or whole-body radiation therapy;
- A diagnosis of radiation-induced lymphocytopenia or baseline lymphocytopenia graded ≥ Grade 2 (according to the CTCAE criteria) prior to study enrollment;
- Patients with a history of or known primary immunodeficiency, active autoimmune disease, long-term systemic glucocorticoid therapy (prednisone-equivalent dose > 10 mg/day), or long-term use of immunosuppressants following organ transplantation;
- History of concurrent malignancy (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that has been treated curatively and has been recurrence-free for at least 5 years);
- Pregnant or lactating women;
- Any other condition deemed by the investigator to render the subject unsuitable for participation in this clinical study, including severe hepatic, renal, hematologic, or other organ dysfunction;
- Irreversible contraindications to the radiotherapy plan or dose delivery.
Trial locations and contacts
1 site in 1 country.
About this study
This study is being done to find out whether features of the thymus gland can predict a common side effect of radiation therapy for lung cancer called radiation-induced lymphopenia.
We will include adults with stage III non-small cell lung cancer (NSCLC) who are scheduled to receive curative radiation therapy to the chest, with or without chemotherapy.
Read more
Before, during, and after radiation therapy, we will measure:
The dose of radiation that reaches the thymus gland (based on each patient's treatment plan)
The size and shape of the thymus gland (using CT scans taken for radiation planning)
The number of lymphocytes (a type of immune cell) in routine blood samples
The main goal is to see if certain radiation doses to the thymus, or a smaller thymus size, can predict severe lymphopenia. We will also check whether lymphopenia affects patient outcomes such as infections or survival.
This is an observational study (no added treatment or drug) - patients will receive their standard radiation therapy as planned by their doctor. The study only collects and analyzes data from standard scans and blood tests.
Potential benefits: Findings may help doctors design "immune-sparing" radiation plans in the future to reduce lymphopenia. Potential risks: There are no additional risks beyond standard radiation therapy, as this study does not change your treatment.
- Being tested
- Definitive Thoracic Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definitive Thoracic RadiotherapyRadiation
Also called IMRT / VMAT for NSCLC, Chest radiotherapy, Thoracic radiation therapy
Patients with stage III non-small cell lung cancer (NSCLC) receive standard-of-care definitive radiotherapy to the chest, with or without concurrent/sequential chemotherapy. Radiotherapy is delivered using conventional fractionation (typically 1.8-2.0 Gy per fraction, total dose 50-66 Gy) or hypofractionated regimens as per institutional protocols. Treatment planning is performed using intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT) For the purposes of this observational study, the radiation dose-volume parameters of the thymus gland (e.g., Dmean, V5Gy, V10Gy, V20Gy) are extracted from each patient's treatment planning system. Morphologic features of the thymus (volume, density, transverse diameter) are measured from planning CT scans.
Definitive Thoracic RadiotherapyRadiation
Also called Thoracic radiation therapy, Chest radiotherapy, IMRT / VMAT for NSCLC
Patients with stage III non-small cell lung cancer (NSCLC) receive standard-of-care definitive radiotherapy to the chest, with or without concurrent/sequential chemotherapy. Radiotherapy is delivered using conventional fractionation (typically 1.8-2.0 Gy per fraction, total dose 50-66 Gy) or hypofractionated regimens as per institutional protocols. Treatment planning is performed using intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients whose thymus gland receives a relatively high radiation dose during definitive thoracic radiotherapy for stage III non-small cell lung cancer (NSCLC). High exposure is defined prospectively based on dose-volume histogram parameters - for example, mean thymus dose (Dmean) greater than a pre-specified threshold or V5 (percentage of thymus volume receiving ≥5 Gy) above a predefined cutoff. These patients are also characterized by certain thymus morphologic features (e.g., smaller thymus volume or higher CT density) on pre-treatment planning CT. All patients in this cohort receive standard-of-care radiotherapy (with or without chemotherapy) without any study-specific intervention. The cohort serves as the index group to assess the predictive value of thymus-related parameters for radiation-induced lymphopenia. Receives: Radiation: Definitive Thoracic Radiotherapy | |
| Cohort 2 | Patients whose thymus gland receives a relatively low radiation dose during definitive thoracic radiotherapy for stage III non-small cell lung cancer (NSCLC). These patients serve as the control comparison for evaluating the occurrence and severity of radiation-induced lymphopenia. They receive the same standard radiotherapy regimen (with or without chemotherapy) as the high-exposure cohort. No study-specific intervention is applied. This cohort allows determination of whether higher thymus radiation dose is associated with a greater risk of severe lymphopenia after adjusting for other clinical factors. Receives: Radiation: Definitive Thoracic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe radiation-induced lymphopenia (grade ≥3)
Occurrence and severity of radiation-induced lymphopenia during definitive thoracic radiotherapy for stage III non-small cell lung cancer. Lymphopenia is defined based on absolute lymphocyte count (ALC) measured from peripheral blood samples. Severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0:
Grade 1: ALC < lower limit of normal to 800 cells/μL
Grade 2: ALC 500 - <800 cells/μL
Grade 3: ALC 200 - <500 cells/μL
Grade 4: ALC <200 cells/μL
The primary analysis will focus on grade ≥3 lymphopenia as the main endpoint. Absolute lymphocyte count nadir (lowest value during treatment) and relative change from baseline are also captured as continuous secondary measures within this outcome.
Measured: From baseline (within 7 days before radiotherapy initiation) to 6 weeks after completion of radiotherapy.
radiation-induced lymphopenia
Occurrence and severity of radiation-induced lymphopenia during definitive thoracic radiotherapy for stage III non-small cell lung cancer. Lymphopenia is defined based on absolute lymphocyte count (ALC) measured from peripheral blood samples. Severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Grade 1: ALC < lower limit of normal to 800 cells/μL Grade 2: ALC 500 - <800 cells/μL Grade 3: ALC 200 - <500 cells/μL Grade 4: ALC <200 cells/μL The primary analysis will focus on grade ≥3 lymphopenia as the main endpoint. Absolute lymphocyte count nadir (lowest value during treatment) and relative change from baseline are also captured as continuous secondary measures within this outcome.
Measured: From baseline (within 7 days before radiotherapy initiation) to 6 weeks after completion of radiotherapy. ALC is measured at least weekly during radiotherapy, at the end of radiotherapy, and at 4-6 weeks post-radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start10 Apr 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced LymphopeniaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- You Peimeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, You Peimeng, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564089
- Sponsor's protocol ID
- TRIPLE-NSCLC Study
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thymus Dosimetric and Morphologic Predictors of Radiation-Induced Lymphopenia in Stage III NSCLC
- ClinicalTrials.gov ID
- NCT07564089
- Acronym / sponsor ID
- TRIPLE-NSCLC Study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (actual)
- Lead sponsor
- You PeimengUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 4 May 2026 (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 being done to find out whether features of the thymus gland can predict a common side effect of radiation therapy for lung cancer called radiation-induced lymphopenia.
We will include adults with stage III non-small cell lung cancer (NSCLC) who are scheduled to receive curative radiation therapy to the chest, with or without chemotherapy.
Before, during, and after radiation therapy, we will measure:
The dose of radiation that reaches the thymus gland (based on each patient's treatment plan)
The size and shape of the thymus gland (using CT scans taken for radiation planning)
The number of lymphocytes (a type of immune cell) in routine blood samples
The main goal is to see if certain radiation doses to the thymus, or a smaller thymus size, can predict severe lymphopenia. We will also check whether lymphopenia affects patient outcomes such as infections or survival.
This is an observational study (no added treatment or drug) - patients will receive their standard radiation therapy as planned by their doctor. The study only collects and analyzes data from standard scans and blood tests.
Potential benefits: Findings may help doctors design "immune-sparing" radiation plans in the future to reduce lymphopenia. Potential risks: There are no additional risks beyond standard radiation therapy, as this study does not change your treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Radiation: Definitive Thoracic RadiotherapyPatients whose thymus gland receives a relatively high radiation dose during definitive thoracic radiotherapy for stage III non-small cell lung cancer (NSCLC). High exposure is defined prospectively based on dose-volume histogram parameters - for example, mean thymus dose (Dmean) greater than a pre-specified threshold or V5 (percentage of thymus volume receiving ≥5 Gy) above a predefined cutoff. These patients are also characterized by certain thymus morphologic features (e.g., smaller thymus volume or higher CT density) on pre-treatment planning CT. All patients in this cohort receive standard-of-care radiotherapy (with or without chemotherapy) without any study-specific intervention. The cohort serves as the index group to assess the predictive value of thymus-related parameters for radiation-induced lymphopenia. |
| Cohort 2 | – | Radiation: Definitive Thoracic RadiotherapyPatients whose thymus gland receives a relatively low radiation dose during definitive thoracic radiotherapy for stage III non-small cell lung cancer (NSCLC). These patients serve as the control comparison for evaluating the occurrence and severity of radiation-induced lymphopenia. They receive the same standard radiotherapy regimen (with or without chemotherapy) as the high-exposure cohort. No study-specific intervention is applied. This cohort allows determination of whether higher thymus radiation dose is associated with a greater risk of severe lymphopenia after adjusting for other clinical factors. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational study will enroll adult patients with stage III non-small cell lung cancer (NSCLC) who are scheduled to receive definitive thoracic radiotherapy (with or without concurrent/sequential chemotherapy) at participating oncology centers. Patients are identified consecutively from radiation oncology departments during routine pre-radiotherapy planning visits. No experimental treatment or randomization is applied. The study population includes both treatment-naïve patients and those who may have received prior systemic therapy as long as they have not undergone prior thoracic radiotherapy or have persistent grade ≥3 lymphopenia at baseline. The target sample size is determined based on event-per-variable criteria. Both inpatients and outpatients are eligible. Recruitment is performed prospectively over an estimated period of 18-24 months. All enrolled patients must meet the full eligibilit.
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- Pathologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) with a clinical stage of III (according to the 8th edition or latest version of the AJCC staging system);
- Eligible for radical radiotherapy or chemoradiotherapy to the chest, with a planned total dose of ≥50 Gy to the chest, using a fractionation schedule of 1.8-2.0 Gy per fraction (conventional fractionation) or a high-dose fractionation regimen permitted by the protocol;
- Planned to undergo periodic blood tests before and after radiotherapy, including absolute lymphocyte count;
- ECOG performance status of 0-2;
Key exclusion criteria (7 listed)
- Previous history of thoracic or whole-body radiation therapy;
- A diagnosis of radiation-induced lymphocytopenia or baseline lymphocytopenia graded ≥ Grade 2 (according to the CTCAE criteria) prior to study enrollment;
- Patients with a history of or known primary immunodeficiency, active autoimmune disease, long-term systemic glucocorticoid therapy (prednisone-equivalent dose > 10 mg/day), or long-term use of immunosuppressants following organ transplantation;
- History of concurrent malignancy (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that has been treated curatively and has been recurrence-free for at least 5 years);
- Pregnant or lactating women;
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 |
|---|---|---|
| Definitive Thoracic RadiotherapyAlso: IMRT / VMAT for NSCLC, Chest radiotherapy, Thoracic radiation therapyPatients with stage III non-small cell lung cancer (NSCLC) receive standard-of-care definitive radiotherapy to the chest, with or without concurrent/sequential chemotherapy. Radiotherapy is delivered using conventional fractionation (typically 1.8-2.0 Gy per fraction, total dose 50-66 Gy) or hypofractionated regimens as per institutional protocols. Treatment planning is performed using intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT) For the purposes of this observational study, the radiation dose-volume parameters of the thymus gland (e.g., Dmean, V5Gy, V10Gy, V20Gy) are extracted from each patient's treatment planning system. Morphologic features of the thymus (volume, density, transverse diameter) are measured from planning CT scans. | Radiation | Cohort 1 |
| Definitive Thoracic RadiotherapyAlso: Thoracic radiation therapy, Chest radiotherapy, IMRT / VMAT for NSCLCPatients with stage III non-small cell lung cancer (NSCLC) receive standard-of-care definitive radiotherapy to the chest, with or without concurrent/sequential chemotherapy. Radiotherapy is delivered using conventional fractionation (typically 1.8-2.0 Gy per fraction, total dose 50-66 Gy) or hypofractionated regimens as per institutional protocols. Treatment planning is performed using intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT) | Radiation | Cohort 2 |
Primary outcome
Severe radiation-induced lymphopenia (grade ≥3)
Time frame: From baseline (within 7 days before radiotherapy initiation) to 6 weeks after completion of radiotherapy.
Occurrence and severity of radiation-induced lymphopenia during definitive thoracic radiotherapy for stage III non-small cell lung cancer. Lymphopenia is defined based on absolute lymphocyte count (ALC) measured from peripheral blood samples. Severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0: Grade 1: ALC < lower limit of normal to 800 cells/μL Grade 2: ALC 500 - <800 cells/μL Grade 3: ALC 200 - <500 cells/μL Grade 4: ALC <200 cells/μL The primary analysis will focus on grade ≥3 lymphopenia as the main endpoint. Absolute lymphocyte count nadir (lowest value during treatment) and relative change from baseline are also captured as continuous secondary measures within this outcome.
radiation-induced lymphopenia
Time frame: From baseline (within 7 days before radiotherapy initiation) to 6 weeks after completion of radiotherapy. ALC is measured at least weekly during radiotherapy, at the end of radiotherapy, and at 4-6 weeks post-radiotherapy.
Occurrence and severity of radiation-induced lymphopenia during definitive thoracic radiotherapy for stage III non-small cell lung cancer. Lymphopenia is defined based on absolute lymphocyte count (ALC) measured from peripheral blood samples. Severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Grade 1: ALC < lower limit of normal to 800 cells/μL Grade 2: ALC 500 - <800 cells/μL Grade 3: ALC 200 - <500 cells/μL Grade 4: ALC <200 cells/μL The primary analysis will focus on grade ≥3 lymphopenia as the main endpoint. Absolute lymphocyte count nadir (lowest value during treatment) and relative change from baseline are also captured as continuous secondary measures within this outcome.
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 4 May 2026.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation-induced Lymphopenia and Thymus Dosimetric, run by You Peimeng 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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 4 May 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe radiation-induced lymphopenia (grade ≥3) (time frame: From baseline (within 7 days before radiotherapy initiation) to 6 weeks after completion of radiotherapy.). 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 4 May 2026.