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 (FENOTYPE)

June 19, 2025 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients with metastatic non-small-cell lung cancer
Other: Measurement of FeNO
Before the first immunotherapy infusion and at the follow-up visit after the 4th course of immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after 4 courses of immunotherapy, an average of 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEORGES 2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Non-small Cell Lung Cancer

Clinical Trials on Measurement of FeNO

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe