Using breath tests to predict response to lung cancer immunotherapy
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
This study is testing if measuring a gas in your breath can help doctors predict how well lung cancer patients will respond to a specific immunotherapy treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Dijon) |
| Trial ID | NCT05985330 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the role of fractional exhaled nitric oxide (FeNO) as a prognostic marker for predicting the response to anti-PD-L1 immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC). Participants will undergo breath testing to measure FeNO levels before starting immunotherapy and again after the fourth treatment session. The study seeks to determine if FeNO levels can provide a more accurate prediction of treatment efficacy compared to current markers. By understanding the relationship between FeNO and treatment response, the study hopes to improve personalized treatment strategies for lung cancer patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with untreated metastatic NSCLC and PD-L1 tumor expression greater than 50%.
Not a fit: Patients with prior treatment for NSCLC or those with specific oncogene addictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of immunotherapy effectiveness, allowing for tailored treatment plans for lung cancer patients.
How similar studies have performed: While the use of breath analysis in cancer treatment is an emerging field, this specific approach using FeNO as a prognostic marker is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Marjolaine GEORGES
- Email: marjolaine.georges@chu-dijon.fr
- Phone: 03.80.29.37.72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.