Clinical trial · Observational
Multi-Omics Prediction of Radiation Lung Injury in Immunotherapy-Treated Lung Cancer Patients
Multi-Omics Prediction of Radiation Pneumonitis Risk in Lung Cancer Patients After Immunotherapy and Thoracic Radiotherapy
NCT07742800CI-TRIAL-00120361not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Cancer (SCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention: Observational Cohort | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Lung Cancer Patients Receiving Sequential Immunotherapy and Thoracic Radiotherapy
- interventionNames
- Other: No Intervention: Observational Cohort
Primary outcomes (1)
- measure
- Area Under the Receiver Operating Characteristic Curve (AUC) of the Multi-Omics Prediction Model for Radiation Pneumonitis
- timeFrame
- At 6 months post-radiotherapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. \-
References
Publications (0)
Data not yet available
No reference posted for this study.