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Testing zongertinib compared to standard treatment in patients with early-stage non-small cell lung cancer with HER2 mutations after surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at non-small cell lung cancer that has been surgically removed and has specific changes called HER2 mutations in the tyrosine kinase domain, which is a part of a protein that helps cells grow. The cancer being studied is in the early stages, specifically Stage II to IIIB, meaning it has not spread widely through the body. The study will test a medication called zongertinib, which is also known by its code name BI 1810631, and will compare it to standard of care treatments. Standard of care means the usual treatment that doctors currently use for this type of cancer, which may include medications such as pembrolizumab, atezolizumab, nivolumab, or durvalumab. The medication zongertinib is given as a tablet by mouth, while the standard of care medications are given through a vein as an infusion.

The purpose of this study is to find out if zongertinib works better than standard of care treatment in preventing the cancer from coming back after surgery. The study will measure how long patients live without their cancer returning, which is called disease-free survival. The study will also look at how long patients live overall and will check for any serious side effects from the treatments. Patients in this study will be randomly assigned to receive either zongertinib or one of the standard of care treatments, or they may be observed without additional treatment after surgery.

During the study, patients will be monitored regularly to check if the cancer comes back and to watch for any side effects from the treatment. The treatment with zongertinib can last up to 36 months, while the standard of care treatments can last up to 12 months. Patients will need to have their cancer tissue tested to confirm that it has the specific HER2 mutations required for the study. The study will follow patients for several years to gather information about whether the treatment helps keep the cancer from returning and to understand the safety of the medications being tested.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial consent and enrollment

    A signed and dated written consent form will be completed in accordance with international guidelines and local regulations prior to admission to the trial.

    Eligibility will be confirmed, including age verification (18 years or older, or above the legal age of consent in the country).

    A tumor tissue sample previously collected will be submitted to a central laboratory after inclusion to confirm the presence of HER2 mutations (specific changes in a gene called HER2 that can affect cancer growth).

  2. Step 2

    Baseline assessments

    Performance status will be evaluated using the ECOG score (a scale from 0 to 5 that measures how the disease affects daily living abilities). An ECOG score of 0 or 1 is required.

    Laboratory tests will be performed to assess adequate organ function.

    The cancer stage will be confirmed as not exceeding Stage IIIB (a classification indicating the extent of cancer spread).

    The diagnosis of primary non-small cell lung cancer (a type of lung cancer) will be confirmed through tissue examination.

  3. Step 3

    Randomization

    Random assignment will occur to one of the treatment groups: either zongertinib (the investigational medication) or standard of care treatment.

    Standard of care may include one of the following medications administered through a vein: pembrolizumab, atezolizumab, nivolumab, or durvalumab, or observation without active treatment.

  4. Step 4

    Treatment phase

    If assigned to the zongertinib group, the medication will be taken by mouth in the form of a film-coated tablet. Specific dosage, frequency, and duration will be determined by the study protocol.

    If assigned to the standard of care group with active treatment, one of the following medications will be administered through a vein as an infusion: pembrolizumab (25 mg/mL concentrate), atezolizumab (1,200 mg concentrate), nivolumab (10 mg/mL concentrate), or durvalumab (50 mg/mL concentrate). The specific medication, dosage, and schedule will be determined according to standard treatment protocols.

    If assigned to the observation arm of the standard of care group, no active medication will be administered during this phase.

    Treatment will continue as specified in the study protocol.

  5. Step 5

    Monitoring and safety assessments

    Regular monitoring visits will occur throughout the treatment phase and follow-up period.

    Safety will be assessed by monitoring for adverse events (unwanted or harmful reactions) of Grade 3 or higher according to CTCAE version 5.0 (a standardized system for classifying the severity of side effects).

    Safety monitoring will continue from the start of treatment (or from randomization for those in the observation arm) until tumor recurrence or up to 3 years after treatment begins, whichever comes first.

  6. Step 6

    Disease monitoring

    Regular assessments will be conducted to monitor for disease-free survival (the length of time after treatment during which no cancer is found).

    Monitoring will track the time from randomization until tumor recurrence or death from any cause, whichever occurs earlier.

    Assessments will be performed by the investigator according to the study schedule.

  7. Step 7

    Long-term follow-up

    Long-term follow-up will continue to assess overall survival (the length of time from randomization until death from any cause).

    Follow-up visits will occur at specified intervals as outlined in the study protocol.

    The trial is estimated to continue until September 2036.

Who can join the trial?

10 criteria

  • You must sign and date a written consent form before joining the trial
  • You must be at least 18 years old or above the legal age of consent in your country
  • Both men and women can participate. Women who can become pregnant must be willing to use two highly effective methods of birth control, which are methods that prevent pregnancy with less than 1% failure rate when used correctly
  • You must have a documented HER2 mutation, which is a specific change in a gene called HER2 that affects how cancer cells grow
  • You must have a confirmed diagnosis of primary non-small cell lung cancer, which is a type of lung cancer confirmed by examining tissue under a microscope
  • A sample of your tumor tissue from a previous procedure must be sent to a central laboratory after you join the study to confirm your HER2 status
  • Your cancer must not be more advanced than Stage IIIB, which means the cancer has not spread extensively throughout your body
  • You must have an ECOG performance status of 0 or 1, which is a scale that measures how well you can perform daily activities, where 0 means you are fully active and 1 means you have some restrictions but can still do light work
  • Your organs must function adequately based on laboratory blood test results
  • Additional requirements may apply

Who cannot join the trial?

3 criteria

  • The study information provided does not contain specific exclusion criteria, which are the reasons why a patient cannot participate in this clinical trial
  • Without detailed exclusion criteria listed in the study documents, it is not possible to provide specific reasons that would prevent participation
  • Generally, clinical trials may exclude patients based on factors such as other health conditions, previous treatments, or test results, but these specific details are not available in the current study information
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Investigated drugs

  • Zongertinib

    is an investigational medication being studied in this trial. It is designed to target and block specific changes in cancer cells called HER2 mutations. These mutations can help cancer cells grow and survive. By blocking these mutations, zongertinib may help prevent cancer from coming back after surgery. In this study, zongertinib is being given as a single treatment after surgery to see if it works better than standard care at keeping lung cancer from returning.

  • Standard of care

    refers to the usual treatment that doctors currently use for patients with early-stage lung cancer after surgery. This may include chemotherapy, other cancer medications, or observation without additional treatment, depending on what is considered the best current practice for each patient's specific situation. In this trial, the standard of care is being compared to zongertinib to see which approach is more effective at preventing the cancer from coming back.

What is already known about the treatment

Zongertinib – Zongertinib is an experimental medication currently being studied in clinical trials for the treatment of early-stage non-small cell lung cancer in patients whose tumors have specific HER2 mutations. It is being tested as an adjuvant therapy, which means it would be given after surgery to help prevent cancer from coming back. The drug works by blocking abnormal HER2 proteins that have mutations in their tyrosine kinase domain, which are molecular switches that help cancer cells grow and survive. Zongertinib belongs to a class of medications called tyrosine kinase inhibitors, which are targeted therapies designed to interfere with specific molecules involved in tumor growth.

Investigated diseases

Non-small cell lung cancer – Non-small cell lung cancer is a type of cancer that begins in the lungs and is the most common form of lung cancer. The disease develops when cells in the lung tissue start to grow abnormally and uncontrollably, forming tumors. These abnormal cells can invade nearby tissues and may spread to other parts of the body through the bloodstream or lymphatic system. The cancer typically grows and spreads more slowly compared to other types of lung cancer. As the disease progresses, the tumor can increase in size and affect normal lung function. Recurrence of the tumor may occur even after initial treatment.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521284-12-00Protocol code1479-0032Estimated enrolment400 patientsSponsorBoehringer Ingelheim Espana S.A.

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