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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05985330
Acronym
FENOTYPE
Enrollment
56
Registered
2023-08-14
Start date
2023-09-26
Completion date
2030-09-01
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Non-small Cell Lung Cancer

Brief summary

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.

Interventions

OTHERMeasurement of FeNO

Before the first immunotherapy infusion and at the follow-up visit after the 4th course of immunotherapy

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patients previously treated for NSCLC * 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

Design outcomes

Primary

MeasureTime frameDescription
Response to immunotherapy by CT scanafter 4 courses of immunotherapy, an average of 9 weeksEvaluation according to RECIST criteria by comparing FeNO levels between patients responding and not responding to immunotherapy.

Countries

France

Contacts

CONTACTMarjolaine GEORGES
marjolaine.georges@chu-dijon.fr03.80.29.37.72

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026