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NCT Number: NCT05985330

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

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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Key information

Conditions

Metastatic Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of FeNO

Other

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

Primary outcomes

  1. Response to immunotherapy by CT scan

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marjolaine GEORGES

CONTACT

[email protected]

03.80.29.37.72

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: FENOTYPE

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Aug 14, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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