Clinical trial · Observational
Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume
Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume in Patients With Non-Small Cell Lung Cancer: A Case-Control Study
- 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)
In this study, investigators plan to test whether Immune Checkpoint Inhibitor (ICI) treatment leads to an accelerated progression of atherosclerosis in patients with lung cancer. Atherosclerosis is an immune-mediated inflammatory disease and these same checkpoints being targeted for cancer are critical negative regulators of atherosclerosis in animal and cellular models. Aortic plaque progression will be compared between cases (on ICI) and controls from pre-ICI to post-ICI among patients with non-small cell lung cancer. Groups will be matched for age, cancer type and stage and cardiovascular risk factors. Traditional markers of cardiovascular (CVD) risk and cancer-specific factors (ICI mono- and combination therapy, number of cycles, occurrence of immune-related adverse events, chest radiation, steroid use) will be associated with the change in aortic plaque volume.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in aortic plaque volume
- timeFrame
- Three years
- description
- The change of plaque burden after starting ICIs will be calculated and compared with the pre-ICI study. The change in plaque burden in controls will be calculated and compared from two studies at a similar median interval as ICI cases.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Cases: * Subjects with non-small cell lung cancer treated with Immune Checkpoint Inhibitors. * Available contrast enhanced CT scans of the chest both immediately pre-ICI (\< 1 month) and latest follow-up. Controls: * Subjects with non-small cell lung cancer, age, cancer stage and cardiovascular risk factor matched to cases. * Available contrast enhanced CT scan of the chest at two time-points at a similar interval between scans as the cases. Exclusion Criteria: none
References
Publications (1)
- DERIVEDDrobni ZD, Gongora C, Taron J, Suero-Abreu GA, Karady J, Gilman HK, Supraja S, Nikolaidou S, Leeper N, Merkely B, Maurovich-Horvat P, Foldyna B, Neilan TG. Impact of immune checkpoint inhibitors on atherosclerosis progression in patients with lung cancer. J Immunother Cancer. 2023 Jul;11(7):e007307. doi: 10.1136/jitc-2023-007307. PMID 37433718