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RecruitingPHASE3INTERVENTIONAL

Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations

This study, called Beamion LUNG-3, is for adults with a specific type of lung cancer (non-small cell lung cancer, or NSCLC) that has spread a little but has been completely removed by surgery. The cancer must also have a particular genetic change called a HER2 mutation. Participants will have already received standard treatments like chemotherapy around the time of their surgery. The study aims to find out if a new daily tablet called zongertinib is better than current standard treatments at preventing the cancer from returning. Half of the participants will receive zongertinib, and the other half will receive standard care, which might be other approved treatments or close observation. Researchers will also look at side effects and how patients feel during the study.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Boehringer Ingelheim
Enrolment target
400
Start
16 Jan 2026
Estimated completion
02 Sep 2036

What is this study about?

Imagine you've had lung cancer, and doctors have successfully removed it with surgery and given you other treatments like chemotherapy. Even after all that, there's always a worry that the cancer might come back. This study, called Beamion LUNG-3, is looking for a new way to help reduce that worry for some people.

It focuses on a specific type of lung cancer called non-small cell lung cancer (NSCLC) that's been caught at Stage II or IIIB. Crucially, the cancer must also have a particular genetic "switch" turned on, called a HER2 mutation. Think of this as a unique characteristic of your cancer that doctors can sometimes target with special medicines. In this study, they're exploring a new daily tablet named zongertinib, which is designed to specifically target this HER2 mutation.

The main goal of this research is to see if taking zongertinib after surgery and other standard treatments can prevent the cancer from returning for longer compared to what doctors usually do now. They also want to understand any side effects of zongertinib and how it affects patients' overall well-being. By doing this study, researchers hope to find a more effective way to prevent lung cancer from coming back for people with this specific type of tumour.

Key takeaways

  • This study tries to prevent lung cancer from returning after surgery.
  • It's for people with a specific genetic change (HER2 mutation) in their lung cancer.
  • It compares a new daily tablet (zongertinib) with standard follow-up or care.
  • You'll be randomly assigned to one of two groups.
  • Your health will be closely monitored throughout the study.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult (18 or older) who has had non-small cell lung cancer that was fully removed by surgery. Your cancer must have been classed as Stage II or IIIB before treatment. It's also very important that your cancer cells have a specific genetic change called an activating HER2 mutation. You would have already received standard treatments around the time of your surgery, like chemotherapy, and possibly immunotherapy.

There are also some general health requirements. For example, you need to be generally well enough to take part, as assessed by your doctor (often called having a good 'performance status') and your body's organs must be working properly based on blood tests. Women who can have children must agree to use effective birth control during the study.

However, you wouldn't be able to join if your lung cancer has other specific genetic changes that can be treated with different targeted therapies (like EGFR or ALK mutations). You also can't have had certain other conditions, like specific lung diseases, severe infections, or major surgery too recently before the study. Your study doctor will review all your medical information carefully to see if this study is right for you.

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.

  1. Are you 18 years old or older?
  2. Did you have non-small cell lung cancer that was completely removed by surgery?
  3. Did your cancer have a HER2 mutation?
  4. Did you receive chemotherapy around the time of your surgery?
  5. Are you generally feeling well and able to manage daily activities?
  6. Do you not have other specific genetic changes in your cancer (like EGFR or ALK) that are already treatable?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups, like flipping a coin. You'll either receive the new medicine, zongertinib, which is a daily tablet taken for up to three years, or you'll receive the standard care, which could be another approved treatment given after surgery (called immunotherapy) or simply close monitoring (active surveillance). The choice for standard care depends on what your local doctors would typically recommend based on your situation.

Throughout the study, you'll have regular visits to the clinic so doctors can monitor your health, check for any side effects, and see how you're feeling. You'll likely have blood tests, scans, and fill out questionnaires about how you're doing. The researchers will track if your cancer comes back and your overall health. The total duration of your participation will depend on the treatment course, but you will be followed up to track how you are doing.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by giving you access to a new treatment, zongertinib, which might be more effective at preventing your cancer from returning than standard approaches. However, like all medicines, zongertinib may have side effects, which your study doctor will discuss with you. There's also a chance that the new treatment might not work for you, or it could even be less effective than standard care. You might also be in the standard care group and not receive the new drug. Regular monitoring during the study means any changes in your health can be quickly addressed. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (199)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • ClinRé 001-022 (Premier Cancer Care and Infusion Center)
    Verified postcode
    Fresno, United States· Recruiting
  • OPN Healthcare, Inc.
    Verified postcode
    Glendale, United States· Recruiting
  • University of California Irvine
    Verified postcode
    Irvine, United States· Not yet recruiting
  • Sutter Health
    Verified postcode
    Roseville, United States· Not yet recruiting
  • University of California San Francisco
    Verified postcode
    San Francisco, United States· Not yet recruiting
  • Sarcoma Oncology Center
    Verified postcode
    Santa Monica, United States· Not yet recruiting
  • University of California Los Angeles
    Verified postcode
    Santa Monica, United States· Recruiting
  • Northern California Kaiser Permanente
    Verified postcode
    Vallejo, United States· Not yet recruiting
  • George Washington University Cancer Center
    Verified postcode
    Washington D.C., United States· Not yet recruiting
  • Mid Florida Hematology and Oncology Center
    Verified postcode
    Orange City, United States· Recruiting
  • Piedmont Cancer Institute
    Verified postcode
    Atlanta, United States· Recruiting
  • Northwest Georgia Oncology Centers
    Verified postcode
    Marietta, United States· Recruiting

Common questions

What is a HER2 mutation?

It's a specific genetic change in your cancer cells (like a 'switch' being stuck on) that can make the cancer grow. Some medicines can target this specific change.

What does 'adjuvant treatment' mean?

Adjuvant treatment is given after surgery for cancer to try and reduce the chance of the cancer coming back.

What is 'randomized 1:1'?

This means you have an equal (50/50) chance of being assigned to either the new treatment group or the standard treatment group, like flipping a coin.

Can I take part if I have other medical conditions?

Your study doctor will carefully review your full medical history. Some conditions, like certain lung problems, might mean you can't join this study.

How long will I be on the study drug?

If you are in the zongertinib group, you would take the tablet once daily for up to three years.

How to find out more

Boehringer Ingelheim

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

Interested in taking part?

Register your interest

Share your details and the research team for "Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment i…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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