Clinical trial NCT05985330: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Non-small Cell Lung Cancer
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic non-small-cell lung cancer requiring immunotherapy alone

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.


Eligibility criteria: 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

Primary outcomes:
measure: Response to immunotherapy by CT scan
timeFrame: after 4 courses of immunotherapy, an average of 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: