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
| NCT ID | NCT05985330 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Condition | Metastatic Non-small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 56 participants |
| Start Date | 2023-09-26 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 56 participants in total. It began in 2023-09-26 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05985330 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05985330 currently recruiting?
Yes, NCT05985330 is actively recruiting participants. Contact the research team at marjolaine.georges@chu-dijon.fr for enrollment information.
Where is the NCT05985330 trial being conducted?
This trial is being conducted at Dijon, France.
Who is sponsoring the NCT05985330 clinical trial?
NCT05985330 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 56 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.