Actively Recruiting
Pilot Study of Fractional Exhaled Nitric Oxide as a Prognostic Marker of Response to Anti-PD-L1 Immunotherapy in Metastatic Non-small Cell Lung Cancer
Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-06-25
56
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying metastatic non-small cell lung cancer (NSCLC) to evaluate whether measuring fractional exhaled nitric oxide (FeNO) in patients' breath can better predict their response to immunotherapy targeting PD-L1. Immunotherapy uses the body's immune system to fight cancer, but its effectiveness varies among patients. This study aims to find a more accurate marker for treatment response using breath tests before and during therapy. Participants will have their breath tested to measure FeNO before their first immunotherapy infusion and again after the fourth immunotherapy treatment, approximately nine weeks later. The study focuses on patients with metastatic NSCLC who have not been previously treated and whose tumors express PD-L1 at levels greater than 50%. No drug or placebo is given as this is an observational study. During the study, response to immunotherapy will be assessed by CT scans after the fourth treatment course. Participants will have breath tests at two time points to measure FeNO levels. Researchers will monitor treatment response and gather clinical data to understand the predictive value of FeNO. Participation involves these breath tests and imaging scans, with the overall study lasting around nine weeks post-treatment initiation.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with metastatic non-small cell lung cancer
- Patients not previously treated for NSCLC
- PD-L1 tumor expression greater than 50%, planned for immunotherapy alone after multidisciplinary consultation
- Patients aged 18 years or older
- Patients who have given their consent
- Patients who speak and read French
You will not qualify if you...
- Patients previously treated for NSCLC
- Patients with oncogene addiction or first-line targetable rearrangement
- Patients unsuitable for immunotherapy alone
- Patients treated with corticosteroids within 15 days before FeNO measurement
- Patients using inhaled corticosteroids at inclusion
- Blood eosinophilia greater than 500/mm3
- Patients on 24-hour oxygen therapy
- Contraindications to immunotherapy
- Inability to perform FeNO measurement maneuvers
- Pregnant, parturient, or breastfeeding women
- Persons under judicial protection (curatorship, guardianship) or with limited judicial protection
- Adults unable to express consent
- Patients refusing to participate in the study
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 9 weeks
Participants have their Fractional Exhaled Nitric Oxide (FeNO) measured before starting immunotherapy and again after the 4th course of immunotherapy.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Chu Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
Research Team
M
Marjolaine GEORGES
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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