Image

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
18 years of age
Both
Phase N/A

Powered by AI

Overview

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

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 details

Metastatic Non-small Cell Lung Cancer

NCT05985330

Centre Hospitalier Universitaire Dijon

12 January 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.