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
NCT ID: NCT05985330
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
56 participants
OBSERVATIONAL
2023-09-26
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
Patients with metastatic non-small-cell lung cancer
Measurement of FeNO
Before the first immunotherapy infusion and at the follow-up visit after the 4th course of immunotherapy
Interventions
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Measurement of FeNO
Before the first immunotherapy infusion and at the follow-up visit after the 4th course of immunotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patient with oncogene addiction or a first-line targetable rearrangement
* 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.
* Blood eosinophilia \> 500 /mm3
* Patient on 24-hour oxygen therapy
* Contraindication to immunotherapy
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourgogne
Dijon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GEORGES 2022
Identifier Type: -
Identifier Source: org_study_id
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