RecruitingPHASE3INTERVENTIONAL

A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

This study is for people with advanced non-small cell lung cancer that has a specific genetic change called a HER2 mutation. Researchers are trying to find a better treatment for this type of cancer. They are testing a new drug called sevabertinib, which is designed to block the faulty HER2 protein that helps cancer cells grow. The study compares sevabertinib to standard treatments currently used. Doctors want to understand how well sevabertinib works and if it's safe. Participants will either take sevabertinib tablets or receive standard treatment through an infusion. They will be carefully monitored throughout the study.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Bayer

Enrolment target

444

Start

28 Aug 2024

Estimated completion

27 Jun 2029

Advanced Non-small Cell Lung Cancer HER2 Mutation

What is this study about?

This study is for people in the UK who have a type of lung cancer called non-small cell lung cancer that has spread (advanced). What makes this particular study really important is that it focuses on a specific genetic change in the cancer cells. This change is called a HER2 mutation. Think of HER2 as a building block for cells; when it's mutated, it can make cancer cells grow and divide too much. Currently, there's a need for more effective treatments for this specific type of advanced lung cancer.

The main goal of this study is to test a new medicine called sevabertinib. This drug is designed to target and block the faulty HER2 protein in these cancer cells, hopefully stopping them from growing and spreading. Researchers want to compare how well sevabertinib works and how safe it is, compared to the standard treatments that doctors usually give for this type of lung cancer. By doing this comparison, they hope to find out if sevabertinib could be a better option for future patients.

Taking part in a study like this means helping doctors learn more about cancer and new ways to treat it. If sevabertinib proves to be safe and effective, it could offer a new treatment choice for people with HER2-mutated non-small cell lung cancer. It's a way for participants to potentially receive cutting-edge treatment while contributing to medical research for the benefit of others.

Key takeaways

Targets advanced non-small cell lung cancer with a specific HER2 genetic change.
Compares a new drug (sevabertinib) with existing standard treatments.
Sevabertinib aims to block faulty proteins causing cancer growth.
Regular health checks and scans will monitor your progress.
Participation helps advance understanding and treatment of this cancer.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have advanced non-small cell lung cancer that has been identified as having a HER2 mutation through a special test. This means your cancer is either locally advanced (has spread to nearby areas) or has spread further in your body, and current treatments are unlikely to cure it.

It's important that you haven't had any previous full-body treatments for your advanced or spread lung cancer. However, if you had treatment like chemotherapy or radiation before your cancer spread, and it finished at least 12 months ago, you might still be able to join. You also need to be well enough to receive the standard treatments used in this study, which include certain chemotherapy drugs and pembrolizumab.

Quick self-check

Are you 18 years old or older?
Do you have advanced non-small cell lung cancer?
Has a specific HER2 genetic change been found in your cancer?
Have you not yet received full-body treatment for your advanced lung cancer?
Are you generally well enough to receive standard chemotherapy?

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

What does participation involve?

If you join this study, you'll either take sevabertinib tablets twice a day, or you'll receive standard treatment through a drip into your vein every 21 days. Which one you get is decided by chance.

You'll continue your assigned treatment for as long as it's helping you and you don't have severe side effects. If you're on the standard treatment and your cancer starts to get worse, you might have the option to switch to sevabertinib. Throughout the study, the medical team will regularly check how you’re doing. This will involve imaging scans like CT, PET, MRI, and X-rays to see how your cancer is responding. They'll also do blood and urine tests, check your heart with an ECG, and ask you about any side effects you might be experiencing. For women, pregnancy tests will also be done. The study will continue as long as the treatment is beneficial and tolerable, or until you or your doctor decide to stop.

Potential risks and benefits

Taking part in this study could mean you receive a new, potentially effective treatment (sevabertinib) that might work better than current options for your type of cancer. It also means you'll be closely monitored by a medical team. However, all treatments, including sevabertinib and the standard treatments, can have side effects. These risks will be fully explained to you before you decide to join. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (284)

Patty & George Hoag Cancer Center
Newport Beach, United States· Withdrawn
UC San Diego Health - Moores Cancer Center
San Diego, United States· Recruiting
UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology
San Francisco, United States· Recruiting
UCLA Health Santa Monica Cancer Care
Santa Monica, United States· Recruiting
The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street
Fort Lauderdale, United States· Recruiting
Memorial Cancer Institute at Miramar
Miramar, United States· Recruiting
AdventHealth Cancer Institute Orlando
Orlando, United States· Recruiting
Moffitt Cancer Center - Magnolia Campus
Tampa, United States· Recruiting
Moffitt Cancer Center
Tampa, United States· Not yet recruiting
Piedmont Healthcare - Atlanta
Atlanta, United States· Recruiting
John B. Amos Cancer Center
Columbus, United States· Recruiting
University of Illinois Hospital - Outpatient Cancer Care Center
Chicago, United States· Recruiting

+272 more sites — see the official record for the full list.

Common questions

What is a HER2 mutation?

It's a specific change in the genes of your cancer cells that can make them grow and divide too fast. This study focuses on treatments for cancer with this particular change.

What kind of cancer is 'non-small cell lung cancer'?

It's the most common type of lung cancer. 'Advanced' means it has spread from where it started.

Will I definitely get the new drug, sevabertinib?

Not necessarily. Participants are randomly assigned to either receive sevabertinib or standard treatment, but some on standard treatment might switch to sevabertinib later.

What happens if the new drug doesn't work for me?

Your doctors will regularly check how you are doing. If your cancer worsens or you have severe side effects, you will stop the study treatment and discuss other options with your care team.

How long will I be in the study?

You'll continue treatment for as long as it's helping you and you don't have severe side effects, or until you or your doctor decide to stop.

How to find out more

Bayer Clinical Trials Contact

clinical-trials-contact@bayer.com (+)1-888-84 22937 Official trial record

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