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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Dijon

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Measurement of FeNO

    Other intervention

    Before the first immunotherapy infusion and at the follow-up visit after the 4th course of immunotherapy

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: Patients1 intervention

Trial outcomes

Primary outcomes

1

Response to immunotherapy by CT scan

Evaluation according to RECIST criteria by comparing FeNO levels between patients responding and not responding to immunotherapy.

Time frame
after 4 courses of immunotherapy, an average of 9 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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