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RecruitingNCT05985330FENOTYPEUpdated Jul 10, 2026

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

An observational study in Metastatic Non-small Cell Lung Cancer, sponsored by Centre Hospitalier Universitaire Dijon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
56
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Metastatic Non-small Cell Lung Cancer
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 56 is below the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with metastatic non-small-cell lung cancer requiring immunotherapy alone

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
56 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients

    Patients with metastatic non-small-cell lung cancer

    Other: Measurement of FeNO

Interventions

  • OtherMeasurement of FeNO

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

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What researchers measure

Primary outcomes

  1. Response to immunotherapy by CT scan

    Evaluation according to RECIST criteria by comparing FeNO levels between patients responding and not responding to immunotherapy.

    Time frame: after 4 courses of immunotherapy, an average of 9 weeks

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05985330
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Aug 14, 2023
Start date
Sep 26, 2023
Primary completion
Sep 2030 (estimated)
Completion
Sep 2030 (estimated)
Last update
Jul 10, 2026

Study contacts

Marjolaine GEORGES
Contact
marjolaine.georges@chu-dijon.fr
03.80.29.37.72

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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