Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

First-line treatment with osimertinib in EGFR-mutated non-small cell lung cancer, coupled to extensive translational studies (The FIOL-study)

This study, called 'The FIOL-study', is designed for people with a specific type of lung cancer called non-small cell lung cancer, which has a particular gene change known as an EGFR mutation. The main goal is to find out how effective a medication called osimertinib (you might know it as Tagrisso) is. We'll be looking at how well it shrinks tumours. We also want to understand if it helps people live longer without their cancer getting worse, how long the treatment effect lasts, and how safe it is to use. This is a Phase II study, which means we're exploring how well the treatment works before it can be widely used.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Vestre Viken HF

Enrolment target

Start

14 Nov 2024

EGFR-mutated non-small cell lung cancer

What is this study about?

Imagine your body is like a complex machine. Sometimes, a tiny instruction in the machine’s manual (our genes) gets a typo. In non-small cell lung cancer, sometimes there's a specific typo called an 'EGFR mutation.' This typo can make the cancer grow.

This study is looking at a medicine called osimertinib, also known as Tagrisso. It's a special type of drug designed to target cells that have this specific EGFR typo. The main aim is to see how well it works as a first treatment. We want to know if it can shrink tumours effectively, which is a really important step in treating cancer. This is an 'exploratory' study, meaning we're gathering more information about how good the drug is and if it's safe.

The researchers will be very carefully looking at many things. For example, they'll check how long people's cancer stays stable after taking the medicine, how long the treatment keeps working, and how long people live overall. They'll also be looking closely at any effects on the brain, as sometimes lung cancer can spread there. Additionally, they’ll be taking samples of blood and tissue to understand more about how the cancer changes and how the medicine works at a very detailed level.

Key takeaways

This study is for people with a specific type of lung cancer with an EGFR gene change.
It's testing a drug called osimertinib (Tagrisso) to see how well it shrinks tumours.
The study also looks at how safe the drug is and if it helps people live longer.
Participation involves taking tablets and having regular checks and scans.
It's a Phase II study, exploring the drug's effectiveness and safety as a first treatment.
Your involvement could help improve treatments for future patients.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

A key requirement is that you must have been diagnosed with non-small cell lung cancer, and your cancer has to have a specific genetic change called an 'EGFR mutation.' If you've been told your cancer has this specific mutation, then this study might be for you.

There may be other health requirements or previous treatments that would make you either eligible or not eligible. The study team will discuss all these details with you to make sure it's the right fit.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with non-small cell lung cancer?
Has your doctor told you that your cancer has an 'EGFR mutation'?
Is this your first treatment for advanced lung cancer?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you would be taking osimertinib (Tagrisso) tablets. These come in two strengths: 40mg and 80mg. The study team will tell you which strength you would take. You would have regular visits to the hospital or clinic to check on your health, how the medicine is affecting you, and how your cancer is responding. These visits would involve tests like scans to see if your tumour is shrinking or stable, and possibly blood tests or tissue samples.

Throughout the study, the doctors and nurses will monitor you very closely to see how you are doing. The total duration of your participation would depend on how your cancer responds to the treatment and other factors, but you would be regularly checked and supported.

Potential risks and benefits

Potential benefits of participating could include receiving a treatment that might help shrink your tumour and improve your health, under close medical supervision. You would also contribute to understanding more about this type of cancer and its treatment, which could help future patients. As with any medication, there are potential risks and side effects, which the study team will fully explain to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

—
Norway
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Lithuania
—
Sweden

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. 'Non-small cell' refers to how the cancer cells look under a microscope.

What is an EGFR mutation?

EGFR stands for Epidermal Growth Factor Receptor. A mutation means there's a specific change in this gene in the cancer cells that can make them grow.

What is osimertinib (Tagrisso)?

It's a targeted drug designed to block specific signals that help EGFR-mutated cancer cells grow.

What does 'objective response rate' mean?

It's a way for doctors to measure how many patients have their tumours shrink significantly or disappear completely after treatment.

Will I get regular checks during the study?

Yes, you will have regular hospital visits, scans, and tests to monitor your health and the cancer's response.