RecruitingOBSERVATIONAL

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

Immunotherapy helps your body's natural defences fight cancer. It's a big step forward for lung cancer treatment, but it doesn't work the same for everyone. Doctors don’t have a simple way to know beforehand who will benefit most. This study aims to find out if measuring something called 'nitric oxide' in your breath can give us a clearer picture. You'd have this breath test, which is quick and easy, before you start immunotherapy and again after a few treatment cycles. The goal is to see if knowing your nitric oxide levels can help predict how well your treatment might work.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Universitaire Dijon

Enrolment target

Start

26 Sep 2023

Estimated completion

01 Sep 2027

Metastatic Non-small Cell Lung Cancer

What is this study about?

When you have advanced lung cancer, immunotherapy is a modern treatment that helps your own body's defence system, called the immune system, target and destroy cancer cells. This has been a massive breakthrough in treating lung cancer, and it's changed how doctors think about fighting this disease.

However, immunotherapy doesn't work for every patient in the same way. It's hard for doctors to tell in advance who will get the most benefit from this treatment. Currently, there isn't a simple test that can accurately predict how effective immunotherapy will be for a particular person.

This study is trying to find a better way to predict how someone might respond. We're looking at a specific chemical in your breath called 'nitric oxide'. You naturally breathe out nitric oxide, and scientists have found that levels of certain chemicals in the body, including in your breath, might give clues about your health and how treatments might work. The main goal of this study is to see if measuring the amount of nitric oxide in your breath can help predict whether immunotherapy will be effective for you.

Key takeaways

Study aims to find an easier way to predict immunotherapy success.
Participation involves two simple breath tests.
No change to your planned cancer treatment.
Helps scientists understand lung cancer better for future patients.
Study focuses on advanced, previously untreated lung cancer.

Who may be eligible?

This study is for adults over 18 who have an advanced type of lung cancer that hasn't been treated before. You'd need to have a specific marker on your cancer cells (called PD-L1 > 50%) which means immunotherapy is suitable for you as a first treatment, as decided by your medical team. You also need to be able to speak and understand French as the study materials and conversations will be in French.

Some people can't join the study. This includes if you've already had treatment for your lung cancer, or if your cancer has certain gene changes that mean other targeted treatments would be better for you first. If you've recently taken certain steroid medications, or are on inhaled steroids, or if you have very high levels of certain white blood cells (eosinophils), you wouldn't be able to join. Also, if you need oxygen therapy constantly, are unable to do the breath test, or have any other reason why immunotherapy isn't safe for you, you won't be eligible.

Pregnant, breastfeeding women, or anyone under specific legal protection or unable to understand and agree to take part, are also not able to join this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am over 18 years old.
I have advanced lung cancer that has not been treated before.
My doctors have decided that immunotherapy is a suitable first treatment for me.
I have no recent steroid use (in the last 15 days) or ongoing inhaled steroid use.
I do not need continuous oxygen.
I am able to understand and speak French.

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, you will have a simple breath test called a FeNO test. This is a quick and easy test where you breathe into a special device. You'll have this breath test twice: once just before your very first immunotherapy treatment, and then again after you've completed your fourth course of immunotherapy. This allows us to compare your breath results at different stages of your treatment. Apart from these two breath tests, you will continue with your planned immunotherapy treatment as decided by your doctor. The total duration of your participation in terms of study-specific procedures will be limited to two breath tests over the course of your initial immunotherapy cycles. There are no additional medications involved as part of this study.

Potential risks and benefits

Taking part in this study could potentially help us understand more about how immunotherapy works and who it helps most. While this study won't directly improve your current treatment, the information we learn could benefit future patients with lung cancer. The main procedure, the breath test, is generally safe and doesn't involve any significant risks beyond what you might expect from a simple breathing exercise. You are free to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

Chu Dijon Bourgogne
Verified postcode
Dijon, France· Recruiting

Common questions

What is immunotherapy?

Immunotherapy is a type of cancer treatment that uses your body's own immune system to fight cancer cells.

What is a breath test?

It's a simple test where you breathe into a device to measure specific gases, like nitric oxide, in your breath.

Will this study change my cancer treatment?

No, taking part in this study won't change your planned immunotherapy treatment. You'll still receive the care your doctor has recommended.

How long does the breath test take?

The breath test is usually very quick, often just a few minutes.

Why is this research important?

This research could help doctors better predict who will benefit most from immunotherapy in the future, allowing for more personalised treatment plans.

How to find out more

Marjolaine GEORGES

marjolaine.georges@chu-dijon.fr 03.80.29.37.72 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.