An observational study in Lung Cancer (NSCLC) and Lung Cancer (SCLC), sponsored by HAN GUANG. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by HAN GUANG · Observational
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.
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 160 is below the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →This is the only study on the registry with HAN GUANG as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Patients aged 18 or older years with a 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 () as either monotherapy or combination therapy within the past six months, voluntary participation with written , 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 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.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: No Intervention: Observational Cohort
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.
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.
Time frame: At 6 months post-radiotherapy
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2028, 24 months later.
Of 591 non-industry observational studies under Lung Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 162. This study's planned 24 months is below that.
Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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