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Study to Compare Zongertinib with Standard Treatment for Patients with Advanced Non-Small Cell Lung Cancer with HER2 Mutations

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 clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC), specifically the non-squamous subtype. The study is investigating a new treatment called zongertinib (also known by its code name BI 1810631). This treatment is being compared to the current standard treatment for this type of cancer, which includes a combination of medications: pembrolizumab, carboplatin, cisplatin, and pemetrexed. The trial aims to determine if zongertinib is more effective than the standard treatment in patients whose cancer has specific changes in the HER2 gene, known as mutations in the HER2 tyrosine kinase domain.

The purpose of the study is to see if zongertinib can help people with advanced NSCLC that cannot be removed by surgery and has spread to other parts of the body. Participants in the study will receive either zongertinib or the standard treatment, which involves a combination of drugs given through an infusion into a vein. The study will last for several months, and participants will be monitored regularly to see how their cancer responds to the treatment. The main focus is on how long patients live without their cancer getting worse, which is known as progression-free survival.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the effects of the treatment. The study will also look at other outcomes, such as the overall response to the treatment and any side effects experienced. This research is important for finding better ways to treat people with advanced non-small cell lung cancer, especially those with specific genetic changes in their cancer cells.

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

    Joining the study

    Upon joining the study, the patient will have signed a consent form, confirming understanding and agreement to participate.

    The patient must have a confirmed diagnosis of advanced non-squamous non-small cell lung cancer with specific HER2 mutations.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure the patient meets all eligibility criteria, including adequate organ function and a life expectancy of at least 12 weeks.

    The patient must have at least one measurable lesion as determined by medical imaging.

  3. Step 3

    Treatment allocation

    The patient will be randomly assigned to receive either the new treatment, zongertinib (BI 1810631), or the standard treatment.

    Zongertinib is administered orally in the form of film-coated tablets.

  4. Step 4

    Standard treatment

    If assigned to the standard treatment group, the patient will receive a combination of pembrolizumab, platinum-based chemotherapy (either carboplatin or cisplatin), and pemetrexed.

    Pembrolizumab is given as an intravenous infusion, typically at a concentration of 25 mg/mL.

    Carboplatin or cisplatin, and pemetrexed are also administered intravenously as part of the chemotherapy regimen.

  5. Step 5

    Treatment duration

    The treatment will continue as prescribed by the study protocol, with regular monitoring and assessments to evaluate the patient's response.

    The primary goal is to assess progression-free survival, which means the length of time during and after treatment that the patient lives without the cancer worsening.

  6. Step 6

    Ongoing assessments

    Throughout the trial, the patient will undergo regular assessments to monitor health status and treatment effects.

    These assessments include medical imaging and evaluations of any side effects experienced.

  7. Step 7

    Completion of trial

    The trial is expected to continue until June 2028, with ongoing evaluations of treatment effectiveness and safety.

    Upon completion, the patient's overall response and any changes in health status will be reviewed.

Who can join the trial?

12 criteria

  • You must sign a written consent form to participate in the trial.
  • Your organs must be working well enough, as defined in the study guidelines.
  • You should have a life expectancy of at least 12 weeks, according to the doctor's opinion.
  • Both men and women can participate. Women who can have children and men who can father a child must use two reliable methods of birth control.
  • You must be 18 years or older, or the legal age of consent if it's higher than 18 in your country.
  • You need to have a confirmed diagnosis of advanced or spread non-squamous non-small cell lung cancer.
  • You must have a specific change in the HER2 gene, confirmed by local lab results.
  • A sample of your tumor tissue must be sent to a central lab to confirm the HER2 status. If no sample is available, exceptions can be made with written agreement.
  • You should not have received any treatment for cancer that cannot be removed by surgery, is locally advanced, or has spread, and you should not be eligible for a cure.
  • You must have at least one tumor that can be measured, as determined by a local doctor or radiologist.
  • You should be eligible to receive a specific type of chemotherapy and pembrolizumab, according to the product information.
  • Your Eastern Cooperative Oncology Group (ECOG) score, which measures your ability to perform daily activities, should be 0 or 1.

Who cannot join the trial?

5 criteria

  • Patients who have already received any systemic treatment for their lung cancer cannot participate. **Systemic treatment** refers to medication that travels through the bloodstream to reach and affect cells all over the body.
  • Patients with a type of lung cancer that is not **non-squamous non-small cell lung cancer** are excluded. **Non-squamous** means the cancer cells do not have a flat, scale-like shape.
  • Patients without **HER2 TKD mutations** in their cancer cells are not eligible. **HER2 TKD mutations** are specific changes in the genes of cancer cells that can affect how the cancer grows.
  • Patients who have had surgery to remove their lung cancer are not eligible. **Unresectable** means the cancer cannot be removed by surgery.
  • Patients with cancer that is not **locally advanced** or **metastatic** are excluded. **Locally advanced** means the cancer has spread to nearby tissues or lymph nodes, and **metastatic** means the cancer has spread to other parts of the body.
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Investigated drugs

  • Zongertinib (BI 1810631)

    is an oral medication being tested as a first-line treatment for patients with a specific type of lung cancer that cannot be surgically removed. This medication targets mutations in the HER2 gene, which are involved in the growth of cancer cells. The trial aims to determine if zongertinib is more effective than the current standard treatments in delaying the progression of the disease.

  • Pembrolizumab

    is an immunotherapy drug used in the trial as part of the standard treatment. It works by helping the immune system recognize and attack cancer cells. Pembrolizumab is often used in combination with other treatments to enhance its effectiveness against cancer.

  • Platinum-based chemotherapy

    is a type of cancer treatment that uses drugs containing the metal platinum. These drugs work by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, platinum-based chemotherapy is used as part of the standard treatment regimen.

  • Pemetrexed

    is a chemotherapy drug that is used in combination with platinum-based chemotherapy and pembrolizumab in the trial. It works by interfering with the cancer cell's ability to use folate, a vitamin that is necessary for cell division. This helps to slow down or stop the growth of cancer cells.

What is already known about the treatment

Zongertinib – Zongertinib is an oral medication currently being evaluated in clinical trials as a first-line treatment for patients with non-squamous non-small cell lung cancer that cannot be surgically removed and has specific HER2 mutations. It is in the experimental phase and is being compared to standard treatments to determine its effectiveness in prolonging progression-free survival. The drug works by targeting and inhibiting the HER2 tyrosine kinase, which is involved in the growth and spread of cancer cells. Zongertinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Non-squamous non-small cell lung cancer – This is a type of lung cancer that does not originate from squamous cells, which are flat cells lining the airways. It is the most common form of lung cancer and includes subtypes such as adenocarcinoma and large cell carcinoma. The disease typically begins in the outer parts of the lungs and may not cause symptoms until it has progressed. As it advances, it can spread to other parts of the body, including the lymph nodes, bones, and brain. The progression of the disease can vary, with some tumors growing slowly while others may grow and spread more rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504308-27-00Protocol code1479-0008Estimated enrolment424 patientsSponsorBoehringer Ingelheim Espana S.A.

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