Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

IFCT-1802 SAVIMMUNE A phase II single-arm trial evaluating safety and efficacy of Durvalumab in ECOG Performance Status 2-3, treatment-naive, patients with stage IV Non-Small Cell Lung Cancer (NSCLC) and high PD-L1 tumor expression

This study is investigating a new treatment called durvalumab, also known as Imfinzi, for people with advanced non-small cell lung cancer. This is a type of lung cancer that has spread. The study is particularly looking at patients who haven't had treatment before and whose general health isn't very good. The main goal is to find out how safe durvalumab is by checking for serious side effects in the first eight weeks. It will also see if the treatment helps control the cancer, improves quality of life, and if people's general health status gets better. The study is a Phase II trial, meaning it's an early step to see if the treatment works and is safe for this group of patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Intergroupe Francophone De Cancerologie Thoracique

Enrolment target

Start

14 Aug 2024

Non small cell lung cancer Poor general status

What is this study about?

This research study is about a medicine called durvalumab, also known as Imfinzi. It's for people who have advanced non-small cell lung cancer, which is a common type of lung cancer that has spread to other parts of the body. The study is focusing on patients who haven't had treatment for their cancer yet and whose general health isn't strong. Patients like this might feel quite tired or unwell and struggle with daily activities.

The main aim of this study is to understand how safe durvalumab is for these patients. The researchers will be carefully looking for any serious side effects during the first eight weeks of treatment. They also want to see if the medicine can help control the cancer, improve how long people live, and boost their quality of life, which means helping them feel better generally.

By taking part, doctors hope to learn if durvalumab could be a good treatment option for patients with advanced lung cancer who are not currently feeling their best. This information is important because it could lead to better treatments for more people in the future.

Key takeaways

This study evaluates a new treatment, durvalumab (Imfinzi), for advanced lung cancer.
It focuses on patients who are new to treatment and whose general health is not very good.
The main goal is to check for serious side effects and see how safe the treatment is.
It also looks at how well the treatment controls cancer and improves quality of life.
Participants will receive the drug via a drip and have regular check-ups and scans.

Who may be eligible?

To join this study, you must be at least 18 years old. There's no upper age limit, so people of all adult ages can be considered. The study is open to both men and women.

Crucially, you would need to have a specific type of advanced lung cancer called non-small cell lung cancer, which has spread. You shouldn't have had any other treatment for this advanced cancer yet. Also, your general health, often described by how well you can do daily tasks, would need to be at a certain level, indicating you're quite unwell but well enough to potentially receive treatment.

The research team will carry out several tests to make sure you fit all the necessary criteria before you can join the study. This ensures the study is as safe and effective as possible for everyone involved.

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?
Do you have advanced non-small cell lung cancer that has spread?
Have you not had any treatment for your advanced lung cancer yet?
Is your general health such that you might struggle with some daily activities (your doctor will help confirm if you meet this specific level)?
Are you able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study drug, durvalumab (Imfinzi), which is given as a drip into a vein. This treatment will be given on a regular schedule. You will have regular hospital visits for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects.

The main part of the study will focus on the first eight weeks of treatment, where side effects will be closely monitored. However, doctors will continue to follow your progress for a longer period, checking things like how your cancer is responding, your general health, and your quality of life. You will be asked to fill in questionnaires about how you are feeling. The total duration of your participation will depend on how you respond to the treatment and the study plan, but follow-up will continue for many months, potentially years, to track your progress.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new treatment for your lung cancer that might help control your disease and improve your quality of life, especially if other options are limited. However, as with any medication, there are potential risks, including side effects from durvalumab. These side effects can range from mild to severe, and they will be carefully monitored by the study team. You will be given full information about these risks before deciding to join. It's important to remember that participating in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

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Unverified
France

Common questions

What is durvalumab?

Durvalumab (Imfinzi) is a type of cancer medicine designed to help your body's immune system fight cancer cells.

What does 'advanced non-small cell lung cancer' mean?

It means the lung cancer has grown or spread beyond the original site in the lung.

Why is the study focusing on patients who are 'unwell'?

The study aims to see if this treatment is safe and effective for people who haven't had previous treatment and whose general health isn't strong, which is an important group of cancer patients.

What is a 'Phase II' study?

Phase II studies are early stage trials that look at how well a new treatment works and continue to assess its safety in a larger group of people.

Will I stop my current cancer treatment if I join?

This study is for people who haven't had treatment for their advanced lung cancer yet, so typically you wouldn't be on other specific advanced lung cancer treatments. Your doctors will discuss this with you.