Lung Cancer (NSCLC)NCT07742800
Multi-Omics Prediction of Radiation Lung Injury in Immunotherapy-Treated Lung Cancer Patients
An observational study of Lung Cancer (NSCLC) and Lung Cancer (SCLC), run by HAN GUANG at 1 site in China.
Trial summary
This prospective study aims to develop a multi-omics-based predictive model for radiation pneumonitis in lung cancer patients receiving sequential immunotherapy and thoracic radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC), Lung Cancer (SCLC)
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 15 Aug 2028
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective observational cohort study will enroll adult patients with histologically confirmed lung cancer who have received prior immunotherapy and are scheduled to undergo thoracic radiotherapy. Participants will be recruited from the Department of Oncology at Hubei Cancer Hospital. Eligible patients must have no use of antibiotics within 1 week prior to radiotherapy initiation, with no active infection or uncontrolled comorbidities. The study aims to collect blood, urine, and stool samples at baseline for multi-omics profiling. A total of approximately 160 participants will be enrolled.
Who may be able to join
- Patients aged 18 or older years with a life expectancy of at least 6 months. Additional inclusion criteria were a Zubrod performance status of 0-1, documentation of baseline chest computed tomography (CT) scans prior to the initiation of immunotherapy, receipt of at least 2 cycles of systemic therapy (PD-1) as either monotherapy or combination therapy within the past six months, voluntary participation with written informed consent, and appropriate baseline biochemical tests. The radiation dose for thoracic radiotherapy was ≥30Gy for all eligible patients in this study. No use of antibiotics within 1 week prior to the initiation of thoracic radiotherapy.
- Exclusion Criteria:Participation in other interventional clinical studies or treatments, having received investigational drugs or treatments within 4 weeks prior to the first dose, or prior receipt of a solid organ or hematopoietic stem cell transplant, having an active infection, or pre-existing/active ICI-induced pneumonitis.
- -
Who cannot join
None listed.
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430079
Guang Han, hg7913@hotmail.com
About this study
Official title: Multi-Omics Prediction of Radiation Pneumonitis Risk in Lung Cancer Patients After Immunotherapy and Thoracic Radiotherapy
This prospective study aims to develop a multi-omics-based predictive model for radiation pneumonitis in lung cancer patients receiving sequential immunotherapy and thoracic radiotherapy.
Read the detailed description
The combination of immune checkpoint inhibitors with thoracic radiotherapy has yielded substantial survival gains in lung cancer, yet this dual-modality strategy confers a markedly elevated risk of radiation pneumonitis, particularly when radiotherapy follows immunotherapy. To date, no validated biomarkers exist to stratify patients by this risk, constraining both individualized treatment planning and proactive surveillance. This prospective study addresses this unmet need by systematically collecting blood, urine, and stool samples from patients receiving sequential immunotherapy and thoracic radiotherapy. Employing integrative multi-omics platforms, including genomics, transcriptomics, proteomics, and metabolomics, we aim to discover novel molecular signatures capable of accurately predicting radiation pneumonitis susceptibility. Ultimately, by correlating multi-omic profiles with clinical outcomes, we seek to construct a clinically actionable prediction model to inform risk-adapted monitoring, facilitate patient-clinician shared decision-making, and enhance therapeutic safety and quality of life in this expanding patient population.
- Conditions
- Lung Cancer (NSCLC), Lung Cancer (SCLC)
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Radiation Pneumonitis, Multi-Omics, Immunotherapy, Predictive Biomarkers
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
This study involves collection of peripheral blood, urine, and stool samples from lung cancer patients who have received immunotherapy followed by thoracic radiotherapy. Samples are obtained at baseline prior to the initiation of radiotherapy for comprehensive multi-omics profiling, including genomic, transcriptomic, proteomic, and metabolomic analyses. No therapeutic intervention is administered as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer Patients Receiving Sequential Immunotherapy and Thoracic Radiotherapy | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve (AUC) of the Multi-Omics Prediction Model for Radiation Pneumonitis
The area under the ROC curve (AUC) will be calculated to evaluate the predictive performance of a multi-omics-based model-integrating genomic, transcriptomic, proteomic, and metabolomic data-for distinguishing lung cancer patients who develop grade ≥2 radiation pneumonitis from those who do not, following sequential immunotherapy and thoracic radiotherapy. Model performance will be assessed using bootstrap internal validation with 1,000 resamples to estimate optimism-corrected AUC.
Measured: At 6 months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies 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
- 160 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- HAN GUANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HAN GUANG, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742800
- Sponsor's protocol ID
- HBCH-RT-2026-06
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omics Prediction of Radiation Pneumonitis Risk in Lung Cancer Patients After Immunotherapy and Thoracic Radiotherapy
- ClinicalTrials.gov ID
- NCT07742800
- Acronym / sponsor ID
- HBCH-RT-2026-06
- Conditions
- Lung Cancer (NSCLC), Lung Cancer (SCLC)
- Keywords
- Radiation Pneumonitis, Multi-Omics, Immunotherapy, Predictive Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- HAN GUANGUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 3 Aug 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 prospective study aims to develop a multi-omics-based predictive model for radiation pneumonitis in lung cancer patients receiving sequential immunotherapy and thoracic radiotherapy.
Detailed description
The combination of immune checkpoint inhibitors with thoracic radiotherapy has yielded substantial survival gains in lung cancer, yet this dual-modality strategy confers a markedly elevated risk of radiation pneumonitis, particularly when radiotherapy follows immunotherapy. To date, no validated biomarkers exist to stratify patients by this risk, constraining both individualized treatment planning and proactive surveillance. This prospective study addresses this unmet need by systematically collecting blood, urine, and stool samples from patients receiving sequential immunotherapy and thoracic radiotherapy. Employing integrative multi-omics platforms, including genomics, transcriptomics, proteomics, and metabolomics, we aim to discover novel molecular signatures capable of accurately predicting radiation pneumonitis susceptibility. Ultimately, by correlating multi-omic profiles with clinical outcomes, we seek to construct a clinically actionable prediction model to inform risk-adapted monitoring, facilitate patient-clinician shared decision-making, and enhance therapeutic safety and quality of life in this expanding patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer Patients Receiving Sequential Immunotherapy and Thoracic Radiotherapy | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective observational cohort study will enroll adult patients with histologically confirmed lung cancer who have received prior immunotherapy and are scheduled to undergo thoracic radiotherapy. Participants will be recruited from the Department of Oncology at Hubei Cancer Hospital. Eligible patients must have no use of antibiotics within 1 week prior to radiotherapy initiation, with no active infection or uncontrolled comorbidities. The study aims to collect blood, urine, and stool samples at baseline for multi-omics profiling. A total of approximately 160 participants will be enrolled.
Key inclusion criteria (3 listed)
- Patients aged 18 or older years with a life expectancy of at least 6 months. Additional inclusion criteria were a Zubrod performance status of 0-1, documentation of baseline chest computed tomography (CT) scans prior to the initiation of immunotherapy, receipt of at least 2 cycles of systemic therapy (PD-1) as either monotherapy or combination therapy within the past six months, voluntary participation with written informed consent, and appropriate baseline biochemical tests. The radiation dose for thoracic radiotherapy was ≥30Gy for all eligible patients in this study. No use of antibiotics within 1 week prior to the initiation of thoracic radiotherapy.
- Exclusion Criteria:Participation in other interventional clinical studies or treatments, having received investigational drugs or treatments within 4 weeks prior to the first dose, or prior receipt of a solid organ or hematopoietic stem cell transplant, having an active infection, or pre-existing/active ICI-induced pneumonitis.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No Intervention: Observational CohortThis study involves collection of peripheral blood, urine, and stool samples from lung cancer patients who have received immunotherapy followed by thoracic radiotherapy. Samples are obtained at baseline prior to the initiation of radiotherapy for comprehensive multi-omics profiling, including genomic, transcriptomic, proteomic, and metabolomic analyses. No therapeutic intervention is administered as part of this study. | Other | Lung Cancer Patients Receiving Sequential Immunotherapy and Thoracic Radiotherapy |
Primary outcome
Area Under the Receiver Operating Characteristic Curve (AUC) of the Multi-Omics Prediction Model for Radiation Pneumonitis
Time frame: At 6 months post-radiotherapy
The area under the ROC curve (AUC) will be calculated to evaluate the predictive performance of a multi-omics-based model-integrating genomic, transcriptomic, proteomic, and metabolomic data-for distinguishing lung cancer patients who develop grade ≥2 radiation pneumonitis from those who do not, following sequential immunotherapy and thoracic radiotherapy. Model performance will be assessed using bootstrap internal validation with 1,000 resamples to estimate optimism-corrected AUC.
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 3 Aug 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.
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 Lung Cancer (NSCLC) and Lung Cancer (SCLC), run by HAN GUANG 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 3 inclusion and 0 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: opening soon, as of the sponsor's last update on 3 Aug 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?
Contact Guang Han (027-87671663, hg7913@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve (AUC) of the Multi-Omics Prediction Model for Radiation Pneumonitis (time frame: At 6 months post-radiotherapy). 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 3 Aug 2026.