NCT05985330Recruiting
Pilot Study of the Contribution of Fractional Exhaled Nitric Oxide as a Prognostic Marker of Response to Anti-PD-L1 Immunotherapy in Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
Based on the use of the patient's natural defences, immunotherapy mobilizes the immune system to recognize and destroy cancer cells, and it has revolutionized the treatment of lung cancer. However, the effectiveness of immunotherapy varies from patient to patient. At present, we have no weak markers to predict with certainty the efficacy of immunotherapy treatment in a given individual. Current scientific data identifies a number of molecules produced by the cancer cells and their environment which can be detected by various means (blood tests, breath analysis, etc.). The aim of this study is to understand whether the amount of nitric oxide (NO) present in the breath is a more accurate predictor of response to immunotherapy. Participation in this study involves breath testing (to measure FeNO (Fractional exhaled Nitric Oxide)) before receiving the first infusion of immunotherapy, and at the follow-up visit after the 4th course of immunotherapy.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 56 (estimated)
- First submitted
- 24 Jul 2023
- Start date
- 26 Sept 2023
- Primary completion date
- Sept 2030
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Diseases
- Lung cancer
- NCT number
- NCT05985330
What you commit to
- Study type: Observational
- Planned participants: 56
- From 26 Sept 2023 to the primary completion date, Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously treated for NSCLC
- Patient not suitable for immunotherapy alone
- Patient having received corticosteroid treatment in the 15 days prior to FeNO.
- Patient on inhaled corticosteroid at time of inclusion.
- Patient on 24-hour oxygen therapy
- Contraindication to immunotherapy
Other
- Patient with oncogene addiction or a first-line targetable rearrangement
- Blood eosinophilia \> 500 /mm3
- Inability to perform FeNO measurement manoeuvres
- Pregnant, parturient or breast-feeding women
- Person under judicial protection (curatorship, guardianship)
- Person subject to limited judicial protection
- Adult unable to express their non-opposition
- Patient refusing to participate in the study
Who the study is looking for
- Patients with metastatic NSCLC
- Patient not previously treated
- PD-L1 tumor expression \> 50%, to be treated with immunotherapy alone after validation by a multidisciplinary consultation meeting.
- Patients over 18 years of age
- Patient having given his/her non-opposition
- Patient who speaks and reads French
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Dijon Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.