Active not recruitingPHASE3INTERVENTIONAL

Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

This important UK clinical trial is comparing a new medication called furmonertinib with standard chemotherapy. It's for people living with advanced non-small cell lung cancer that has a particular genetic alteration known as an EGFR exon 20 insertion mutation. Participants will be randomly assigned to receive either one of two doses of furmonertinib or chemotherapy. The main goal is to find out if furmonertinib is more effective and safer than current chemotherapy options for patients who haven't had previous treatment for their advanced lung cancer. This is a very common type of lung cancer, and finding new, better treatments is crucial. The study will help doctors understand the best way to treat this specific type of lung cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

ArriVent BioPharma, Inc.

Enrolment target

398

Start

01 Jun 2023

Estimated completion

15 Feb 2028

Metastatic Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer EGFR Exon 20 Mutations

What is this study about?

This study, called FURVENT, is designed for people in the UK who have been diagnosed with locally advanced or metastatic non-small cell lung cancer. This means the cancer has either spread to nearby tissues or to other parts of the body. A key feature for this study is that participants must have a specific genetic change in their cancer, called an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation. This mutation can make the cancer respond differently to treatments.

The study aims to compare a new drug, furmonertinib, with platinum-based chemotherapy, which is a standard treatment. Furmonertinib is part of a group of drugs called targeted therapies that work by blocking specific signals that help cancer cells grow. Researchers want to see if furmonertinib, given as a daily tablet, is more effective and has fewer side effects than chemotherapy for this particular type of lung cancer.

About 375 patients will take part globally, and in the UK, patients will be split into three groups by chance (like drawing straws). One group will receive furmonertinib at a dose of 240 mg daily, another group will receive 160 mg daily, and the third group will receive standard platinum-based chemotherapy. This approach helps researchers get clear answers about which treatment works best. It's an 'open-label' study, meaning both you and your doctors will know which treatment you're receiving.

Key takeaways

New study for advanced non-small cell lung cancer with a specific genetic change (EGFR exon 20 insertion).
Compares a new drug, furmonertinib, with standard chemotherapy.
Aims to find improved first-line treatment options.
Participation involves random assignment to different treatment groups.
Close monitoring and support provided throughout the study.

Who may be eligible?

To be considered for this study, you must have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer. It's crucial that your cancer has the specific EGFR exon 20 insertion mutation, which your doctors will have tested for in your tumour tissue or blood. Your cancer must also not be suitable for treatment with surgery or radiotherapy that would be intended to cure it.

This study is for people who have not yet received any previous treatment specifically for their advanced lung cancer. If you had chemotherapy, immunotherapy, or radiotherapy for lung cancer that hadn't spread (non-metastatic disease) in the past, you might still be eligible, but there needs to have been at least a 12-month break since your last treatment.

Even if you have had brain metastases (where the cancer has spread to the brain), you might still be able to join. This applies if they've been treated and are stable, or if they're new but not causing any symptoms. You must be at least 18 years old to participate.

Quick self-check

Do you have locally advanced or metastatic non-small cell lung cancer?
Has your cancer been tested and confirmed to have an EGFR exon 20 insertion mutation?
Have you *not* had any previous treatment specifically for your advanced lung cancer?
Are you 18 years old or older?
Is your cancer unsuitable for curative surgery or radiotherapy?

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 will be randomly assigned to one of three treatment groups. This is like drawing lots, to ensure fairness. You could receive furmonertinib (an oral tablet) at one of two daily doses, or standard platinum-based chemotherapy given intravenously (into a vein). Your doctor and the study team will explain exactly what your specific treatment involves.

Taking part will involve regular hospital visits for assessments, which will include physical examinations, blood tests, and scans (like CT scans) to monitor your treatment and see how the cancer is responding. The frequency and duration of these visits will depend on which treatment group you are in and how you are responding. You will have ongoing follow-up with the study team to monitor your health and any side effects. The total duration of your participation will vary depending on your individual response to treatment and will be explained in detail by the study team.

Potential risks and benefits

While joining a clinical trial offers the chance to access a new treatment that might be more effective than current options, there are also potential risks involved. All medications, including furmonertinib and chemotherapy, can have side effects, which can vary from mild to severe. The study team will closely monitor you for any side effects and will explain these fully before you agree to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care. Your decision to participate or not will be fully respected by your healthcare team.

Locations (208)

Arrivent Investigative Site
Daphne, United States
Arrivent Investigative Site
Yuma, United States
Arrivent Investigative Site
Fayetteville, United States
Arrivent Investigative Site
Beverly Hills, United States
Arrivent Investigative Site
Fullerton, United States
Arrivent Investigative Site
Long Beach, United States
Arrivent Investigative Site
Los Alamitos, United States
Arrivent Investigative Site
Napa, United States
Arrivent Investigative Site
Orange, United States
Arrivent Investigative Site
Orange, United States
Arrivent Investigative site
Sacramento, United States
Arrivent Investigative Site
San Diego, United States

+196 more sites — see the official record for the full list.

Common questions

What is non-small cell lung cancer?

Non-small cell lung cancer is the most common type of lung cancer. It's different from small cell lung cancer under a microscope.

What is an EGFR exon 20 insertion mutation?

It's a specific change in the DNA of your cancer cells. Finding this change helps doctors choose treatments that target it directly.

What is furmonertinib?

Furmonertinib is a new oral medication designed to specifically block the signals that help lung cancer cells with the EGFR mutation to grow.

What is platinum-based chemotherapy?

This is a standard type of chemotherapy that uses drugs containing platinum to kill cancer cells, often used for lung cancer.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctor will know whether you are receiving furmonertinib or chemotherapy.