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

NCT05985330 | Recruiting

• 1 other identifier: GEORGES 2022
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Non-small Cell Lung Cancer

Outcome Measures

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.

  after 4 courses of immunotherapy, an average of 9 weeks

Study Arms (1)

Patients

Patients with metastatic non-small-cell lung cancer

Other: Measurement of FeNO

Interventions

Measurement of FeNO OTHER

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Marjolaine GEORGES

CONTACT

03.80.29.37.72; marjolaine.georges@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 14, 2023
• Study Start: September 26, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)