Metastatic Non-small Cell Lung CancerFENOTYPENCT05985330
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
An observational study of Metastatic Non-small Cell Lung Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer
- What is being tested?
- Measurement of FeNO
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2023to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic non-small-cell lung cancer requiring immunotherapy alone
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Marjolaine GEORGES, 03.80.29.37.72, marjolaine.georges@chu-dijon.fr
About this study
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.
Read more
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.
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Being tested
- Measurement of FeNO
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of FeNOOther
Before the first immunotherapy infusion and at the follow-up visit after the 4th course of immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with metastatic non-small-cell lung cancer Receives: Other: Measurement of FeNO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to immunotherapy by CT scan
Evaluation according to RECIST criteria by comparing FeNO levels between patients responding and not responding to immunotherapy.
Measured: after 4 courses of immunotherapy, an average of 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start26 Sep 2023
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985330
- Sponsor's protocol ID
- GEORGES 2022
- Acronym
- FENOTYPE
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05985330
- Acronym / sponsor ID
- FENOTYPE / GEORGES 2022
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Measurement of FeNOPatients with metastatic non-small-cell lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic non-small-cell lung cancer requiring immunotherapy alone
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of FeNOBefore the first immunotherapy infusion and at the follow-up visit after the 4th course of immunotherapy | Other | Patients |
Primary outcome
Response to immunotherapy by CT scan
Time frame: after 4 courses of immunotherapy, an average of 9 weeks
Evaluation according to RECIST criteria by comparing FeNO levels between patients responding and not responding to immunotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Non-small Cell Lung Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marjolaine GEORGES (03.80.29.37.72, marjolaine.georges@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to immunotherapy by CT scan (time frame: after 4 courses of immunotherapy, an average of 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.