Clinical trial · Observational
Breathomics as Predictive Biomarker for Checkpoint Inhibitor Response
Breathomics as a Non-invasive, Inexpensive, Point-of-care Predictive Test for Immune Checkpoint Inhibitor Efficacy
- 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)
Immunotherapy with agents stimulating the immune system to act against cancer are now a new standard of care in various cancers as lung cancer and melanoma, but also bladder cancer, kidney cancer and head \& neck cancer. However, even though a subset of patients derives long-term benefit from these agents, depending of cancer type still at least half of patients do not respond to these new drugs. Our understanding of possible factors predicting whether a patient might actually benefit from immunotherapy is poor. Volatile organic compounds (VOCs) are gases exhaled with a person's breath, which are released into the lung from blood and bacteria and therefore can give information about infections as well as inflammation and possibly cancer cells in a person's body. Breath analysis of these VOCs with special devices called electronic noses (eNose) generate a specific electric signals patterns called breathprints. There is early evidence that specific breathprints can actually help to select patients who will be likely to benefit from immunotherapy. This study is being undertaken in an effort to evaluate breathprint analysis as a potential predicting factor for benefit from immunotherapy, so that treatment selection can further be improved. This study is designed to help us identify the role of breathprint analysis to better select patients for immunotherapy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breathprint analysis and patient-reported outcomes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Validation cohort: NSCLC
- description
- Patients with advanced/metastatic NSCLC planned for IO-treatment in one of the following categories * Pembrolizumab monotherapy first-line * Pembrolizumab or nivolumab monotherapy in second or later line
- interventionNames
- Other: Breathprint analysis and patient-reported outcomes
- label
- Cohort 1: NSCLC
- description
- Patients with advanced/metastatic NSCLC planned for Pembrolizumab-chemotherapy combination therapy first-line
- interventionNames
- Other: Breathprint analysis and patient-reported outcomes
- label
- Cohort 2: Melanoma
- description
- Patients with advanced/metastatic melanoma planned for IO-treatment in one of the following categories * Nivolumab/ipilimumab combination treatment 1L * Pembrolizumab or nivolumab monotherapy treatment 1L * Ipilimumab monotherapy 2L
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA * Patients 18 years of age or older * Histologically confirmed advanced/metastatic non-small cell lung cancer, melanoma or solid tumor such as urothelial, kidney or head and neck cancer and planned treatment with * NSCLC validation cohort: Pembrolizumab or Nivolumab * NSCLC Cohort 1: Pembrolizumab-chemotherapy combination therapy 1L * Melanoma Cohort 2: Nivolumab/ipilimumab combination treatment 1L, Pembrolizumab or nivolumab monotherapy treatment 1L , Ipilimumab * Solid tumors Cohort 3: Any ICI-treatment, any line * NSCLC Cohort 4: Chemotherapy-only (either platinum-based combination treatment or docetaxel monotherapy) * At least one measurable lesion as defined by RECIST 1.1. A lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation. * Able to provide informed consent. EXCLUSION CRITERIA * Patients who are unable to perform the breathing manoeuvres needed for eNose-analysis of exhaled air. * Patients who are unable to independently consent to participation in the trial. * Patients with severe, acute, or chronic medical conditions (including uncontrolled diabetes mellitus) or psychiatric conditions or laboratory abnormalities that in the opinion of the Investigator or their physician may cause undue harm or inconvenience to the patient, or that may interfere with the interpretation of study results.
References
Publications (0)
Data not yet available