RecruitingNCT05985330

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

Sponsor

Centre Hospitalier Universitaire Dijon

Enrollment

56 participants

Start Date

Sep 26, 2023

Study Type

OBSERVATIONAL

Conditions

Metastatic Non Small Cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is exploring whether measuring a substance in a person's exhaled breath called fractional exhaled nitric oxide (FeNO) — a marker of airway inflammation — can help predict how well certain patients with advanced non-small cell lung cancer will respond to immunotherapy treatment. **You may be eligible if:** - You have metastatic non-small cell lung cancer (NSCLC) - You have not yet received any prior treatment for your lung cancer - Your tumor has high PD-L1 expression (greater than 50%), making immunotherapy alone the planned treatment - You are 18 or older and can speak and read French **You may NOT be eligible if:** - You have already been treated for NSCLC - Your tumor has a targetable gene mutation (such as EGFR, ALK, ROS1) - You are not a candidate for immunotherapy alone - You have received steroids in the 15 days before the FeNO measurement, or are on inhaled steroids - Your blood eosinophil count is elevated (above 500/mm3) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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