Active not recruitingPHASE1INTERVENTIONAL

Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

This research study, called Beamion LUNG-1, is looking into a new medicine named zongertinib for advanced cancers where the HER2 gene has changed. The study has two main parts. The first part is for adults with various advanced cancers where previous treatments haven't worked. This helps researchers find the highest dose of zongertinib that people can comfortably take. Once the best dose is found, the second part of the study will focus on people with a specific type of non-small cell lung cancer that has a HER2 gene change. Here, the goal is to see if zongertinib can make tumours shrink. Participants take zongertinib tablets once or twice a day and stay in the study as long as they are benefiting from the treatment. Their health and any side effects are closely monitored by doctors.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

608

Start

02 Jul 2021

Estimated completion

30 Aug 2028

Neoplasm Metastasis Non-Small Cell Lung Cancer

What is this study about?

This study is called Beamion LUNG-1, and it's looking at a new medicine called zongertinib. Researchers are interested in zongertinib because it targets a specific change in a gene called HER2, which can be found in some advanced cancers. When the HER2 gene changes, it can sometimes encourage cancer cells to grow. By understanding how zongertinib works against these changes, doctors hope to develop new ways to treat cancer.

The study is being carried out in two main stages. The first stage involves people with various types of advanced cancer that have the HER2 gene change, where standard treatments haven't been successful. The main aim here is to carefully find the best dose of zongertinib – the amount that is most effective while still being manageable for patients. This is really important for patient safety and to make sure future treatments can be given properly.

Once the researchers have found the right dose, the second stage will begin. This stage will focus specifically on people with a type of lung cancer called non-small cell lung cancer, which also has a specific HER2 gene change. In this part, the main goal is to see if zongertinib can actually shrink the tumours in these patients. This all helps to provide important information about whether zongertinib could be a helpful new treatment option for people living with these kinds of advanced cancers.

Key takeaways

Tests a new medicine (zongertinib) for advanced cancers.
Focuses on cancers with specific HER2 gene changes.
Aims to find the safest and most effective dose.
Will then check if the medicine shrinks tumours, especially in lung cancer.
Involves taking daily tablets and regular health checks.
Participants can stay in the study as long as treatment helps.

Who may be eligible?

This study is for adults, aged 18 and over, who have advanced cancer. To be included, your cancer must have spread or cannot be removed by surgery, and it needs to have specific changes in the HER2 gene. You will need to provide a sample of your tumour (which can be an older sample) so that doctors can confirm these HER2 changes.

Because this is a medical study, your general health will be checked. This includes having good kidney and liver function, and your blood counts (like red and white blood cells and platelets) need to be within a healthy range. You should also be able to move around fairly well, and if you've had side effects from previous treatments, these need to have mostly cleared up.

Critically, for specific parts of the study, people with non-small cell lung cancer will be included if their cancer has a particular HER2 gene change. You'll also need to be willing to undergo some tumour biopsies if required by the study, though brain biopsies are not allowed.

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 or older?
Do you have advanced cancer that has spread or cannot be removed?
Has your cancer been tested and confirmed to have changes in the HER2 gene?
Have previous cancer treatments not been successful for you?
Is your general health, including organ function and blood counts, considered good by doctors?
Are you able and willing to provide a tumour sample for testing?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will take the medicine zongertinib as tablets either once or twice a day. This is the first time zongertinib is being given to people in a study like this. You will continue to take the medicine for as long as it is helping you and you are tolerating it well.

During your time in the study, doctors and nurses will regularly check your health. This will involve appointments where they will monitor your tumours to see if the treatment is working. They will also carefully look out for any unwanted effects or side effects that might be caused by zongertinib. All these checks are done to ensure your safety and to understand how the medicine is working. You will be in the study for as long as you are benefiting from the treatment.

Potential risks and benefits

Taking part in an early-stage study like this has potential benefits, as zongertinib could help shrink tumours for some people, especially if other treatments haven't worked. However, it's a new medicine, so not all effects are known, and there's a risk of side effects, some of which could be serious. Researchers will monitor your health closely, but as with any new treatment, there are uncertainties. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (85)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Precision NextGen Oncology
Verified postcode
Beverly Hills, United States
City of Hope-Duarte-56419
Verified postcode
Duarte, United States
City of Hope - Seacliff
Verified postcode
Huntington Beach, United States
City of Hope-Irvine-69674
Verified postcode
Irvine, United States
Valkyrie Clinical Trials
Verified postcode
Los Angeles, United States
University of California Irvine
Verified postcode
Orange, United States
University of California Davis
Verified postcode
Sacramento, United States
Georgetown University
Verified postcode
Washington D.C., United States
Holy Cross Hospital-Fort Lauderdale-57892
Verified postcode
Fort Lauderdale, United States
Winship Cancer Institute
Verified postcode
Atlanta, United States
Hawaii Cancer Care - Honolulu
Verified postcode
Honolulu, United States

Common questions

What is zongertinib?

Zongertinib is a new medicine being tested for cancer that targets specific changes in the HER2 gene.

What types of cancer are included?

Initially, various advanced solid cancers with HER2 gene changes. Later, it will focus on non-small cell lung cancer with a specific HER2 change.

How is the medicine given?

Zongertinib is taken as tablets, either once a day or twice a day.

How long will I be in the study?

You will stay in the study for as long as the treatment is benefiting you and you are tolerating it well.

Will I receive regular check-ups?

Yes, study doctors will regularly check your health, monitor your tumours, and look for any side effects.