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

Metastatic Non-small Cell Lung Cancer Clinical Trial

— FENOTYPE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05985330
• Other study ID #: GEORGES 2022
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: September 2027

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Marjolaine GEORGES
• Phone: 03.80.29.37.72
• Email: marjolaine.georges[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-small Cell Lung Cancer

Intervention

Other:
• Measurement of FeNO
Before the first immunotherapy infusion and at the follow-up visit after the 4th course of immunotherapy

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to immunotherapy by CT scan	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