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

Recruiting

• Conditions: Metastatic Non-small Cell Lung Cancer
• Interventions: Other: Measurement of FeNO

• Registration Number: NCT05985330
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-14
• Study Start: 2023-09-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Measurement of FeNO	Patients with metastatic non-small-cell lung cancer

Primary Outcome Measures

Name	Time	Method
Response to immunotherapy by CT scan	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.

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France