To hear about similar clinical trials, please enter your email below
Trial 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
NCT ID:
NCT05985330
Condition:
Metastatic Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Measurement of FeNO
Description:
Before the first immunotherapy infusion and at the follow-up visit after the 4th course
of immunotherapy
Arm group label:
Patients
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.
Criteria for eligibility:
Study pop:
Patients with metastatic non-small-cell lung cancer requiring immunotherapy alone
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chu Dijon Bourgogne
Address:
City:
Dijon
Zip:
21000
Country:
France
Contact:
Last name:
Marjolaine GEORGES
Phone:
03.80.29.37.72
Email:
marjolaine.georges@chu-dijon.fr
Start date:
September 2024
Completion date:
September 2027
Lead sponsor:
Agency:
Centre Hospitalier Universitaire Dijon
Agency class:
Other
Source:
Centre Hospitalier Universitaire Dijon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05985330
