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Breath test may reveal who benefits from lung cancer immunotherapy

NCT ID NCT05985330

Knowledge-focused Sponsor: Centre Hospitalier Universitaire Dijon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study investigates whether measuring nitric oxide in a person's breath can predict how well they will respond to immunotherapy for advanced non-small cell lung cancer. Participants take a simple breath test before starting immunotherapy and again after four treatment cycles. The goal is to find a non-invasive way to identify which patients are most likely to benefit from this treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If breath nitric oxide levels reliably predict immunotherapy success, doctors could tailor treatment more precisely for lung cancer patients.
What could go wrong
This is a small pilot study, so results may not be conclusive. The breath test may not prove accurate enough to guide treatment decisions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with metastatic non-small-cell lung cancer requiring immunotherapy alone

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic non small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chu Dijon Bourgogne

    RECRUITING

    Dijon, 21000, France

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