Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

OPTIMUNE-LUNG : INTEGRATIVE ANALYSIS OF THE TUMOR MICROENVIRONMENT AND OPTIMIZATION OF THE IMMUNOTHERAPY DURATION IN NON-SMALL CELL LUNG CANCER PATIENTS

This study, called OPTIMUNE-LUNG, is for people in the UK with advanced lung cancer. It’s a Phase II trial, meaning we aim to learn more about how well new treatments work and if they are safe. We're looking closely at how long immunotherapy, a type of treatment that helps your body’s immune system fight cancer, keeps the cancer from growing or spreading. We're also studying how these treatments affect the body and which combinations of medicines are most effective. We hope to get a better understanding of the best way to use these treatments for lung cancer patients, helping doctors decide on the best treatment plans.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Bergonie

Enrolment target

Start

24 Jun 2024

Patients with locally advanced or metastasic Non-Small Cell Lung Carcinoma.

What is this study about?

This study, called OPTIMUNE-LUNG, is exploring how to make treatments for advanced non-small cell lung cancer even better. We're particularly interested in immunotherapy, which helps your own body's immune system fight cancer cells. The main goal is to understand how long these treatments can keep the cancer from growing or spreading. We're also looking for the best way to use these powerful medicines, sometimes in combination with traditional chemotherapy, to give patients the best possible results.

We will be carefully monitoring how well the treatments work over a 12-month period. This involves regular scans to check if the cancer is shrinking or staying stable. Expert doctors will review all the scans to make sure we get a very accurate picture of how each patient is responding to their treatment. This will help us understand which treatments are most effective and for how long.

Beyond simply checking if the treatment works, we're also looking into how it affects your overall health and quality of life. This includes checking for any side effects and seeing how long people live after starting treatment. All this information will help doctors in the future to choose the most suitable and effective treatments for patients with non-small cell lung cancer, tailoring care to individual needs.

Key takeaways

This study explores new ways to treat advanced lung cancer.
It aims to find out how long immunotherapy treatments can control the cancer.
The study includes combinations of immunotherapy and chemotherapy drugs.
Participation involves regular check-ups and scans to monitor progress.
It's a Phase II study, focusing on how well treatments work and their safety.

Who may be eligible?

This study is designed for adults aged 18 or older who have been diagnosed with non-small cell lung cancer. This particular type of lung cancer must be considered "locally advanced," meaning it has grown into nearby tissues but hasn't spread far, or "metastatic," which means it has spread to other parts of the body.

Both men and women are welcome to take part in this study. The medical team will carefully review your health to make sure that taking part is safe and appropriate for you, based on specific health criteria outlined in the study. Your doctor will discuss these criteria with you in detail.

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.

Are you 18 years old or older?
Have you been diagnosed with non-small cell lung cancer?
Is your lung cancer considered locally advanced or has it spread to other parts of your body?
Are you able to attend regular hospital appointments for treatments and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive a specific treatment plan that involves various medications, some of which are immunotherapy and some are chemotherapy. These will be given as infusions (drips) into your vein over a period of time. The type and frequency of treatment will depend on which specific treatment group you are in.

Throughout the study, you will have regular hospital visits for check-ups, blood tests, and imaging scans (like CT scans) to monitor your progress and see how the treatment is working. These scans will help us see if your cancer is stable, shrinking, or growing. The study aims to follow your progress for at least 12 months after you start treatment. We will also monitor any side effects you might experience very closely.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to new and carefully monitored treatments that might help control your lung cancer. However, as with all medical treatments, there are potential risks, including side effects from the medications. The research team will explain all known side effects in detail before you decide to join. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is Non-Small Cell Lung Cancer?

It's the most common type of lung cancer. This study is for people whose cancer is advanced, meaning it has grown nearby or spread to other parts of the body.

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system find and fight cancer cells more effectively.

What does 'Phase II' mean for a study?

A Phase II study means we are exploring whether a new treatment or combination of treatments works well and is safe in a larger group of people after initial safety tests.

Will I know which treatment I'm getting?

The study team will discuss with you the different treatment plans being investigated in this study before you agree to take part.

What happens if the treatment doesn't work for me?

Your doctors will monitor your treatment closely. If the treatment isn't helping or if uncomfortable side effects occur, they will discuss other treatment options with you.