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Zongertinib with cisplatin or carboplatin and pemetrexed, with or without pembrolizumab, for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations

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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 studying locally advanced or metastatic non-small cell lung cancer with HER2 mutations, which are changes in a gene that can help cancer grow. The treatment being tested is zongertinib (also called BI 1810631) taken by mouth, given together with standard chemotherapy medicines such as pemetrexed, cisplatin, or carboplatin, and in some study groups also with pembrolizumab. The purpose of the study is to see how safe this treatment combination is and how well it is tolerated.

The study compares different treatment combinations in adults who have not yet received treatment for this cancer. Treatment is given in cycles, with medicine taken or infused over repeated visits. After the first part of treatment, the study continues with follow-up while treatment is ongoing, to watch for side effects and other health changes. Some people may receive different combinations as part of the study design.

Pemetrexed, cisplatin, and carboplatin are chemotherapy medicines, which are drugs used to kill cancer cells. Pembrolizumab is an immunotherapy medicine, which helps the body's own defense system attack cancer cells. Intravenous means the medicine is given through a vein.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study treatment starts</b>

    After you join the study, your treatment starts for advanced non-small cell lung cancer, which is a type of lung cancer that has spread locally or to other parts of the body.

    You receive zongertinib as a tablet taken by mouth. The study description does not state the dose, how often it is taken, or how long it is given.

    You also receive a pt-doublet, which means a combination of two platinum-based chemotherapy medicines. The study lists cisplatin and carboplatin as possible platinum medicines. These are given by intravenous infusion, which means through a vein. The study description does not state the dose, frequency, or duration for these medicines.

    The study also lists pemetrexed as a test medicine given by intravenous infusion. The study description does not state the dose, frequency, or duration.

    If assigned to that study group, you also receive pembrolizumab by intravenous infusion. The study description does not state the dose, frequency, or duration.

  2. Step 2

    <b>first 2 treatment cycles</b>

    The main part of the study assessment happens during the first 2 cycles of treatment. A cycle is a repeated treatment period used in cancer studies.

    During this time, the study checks whether zongertinib must be stopped or interrupted for more than 7 days because of treatment-related side effects.

    The study also checks whether any side effects lead to a need to lower the dose of zongertinib or stop treatment for a long period.

  3. Step 3

    <b>on-treatment period</b>

    While you are still receiving study treatment, the study records whether you have any serious side effects, which are called sae and mean serious adverse events.

    The study records whether you have any side effects that are grade 3 or higher. This means side effects that are severe or worse.

    The study records whether the combination of medicines causes combination limiting toxicities, which means side effects that limit how the medicines can be given.

    The study continues to record whether zongertinib is reduced, stopped, or interrupted for more than 7 days because of treatment-related side effects.

  4. Step 4

    <b>tumor response checks during treatment</b>

    The study checks whether the cancer shrinks or disappears. This is called the objective response.

    The study uses RECIST 1.1, which is a standard way to measure whether the tumor has changed. In simple terms, it is a set of rules used to see whether the cancer is getting smaller, staying the same, or growing.

    The study also measures how long it takes before a response is first seen, how long a response lasts, and how long you remain on treatment.

  5. Step 5

    <b>end of treatment follow-up</b>

    The study continues until zongertinib is stopped or until death, whichever occurs first.

    The study measures the time from the first dose of study treatment until zongertinib is stopped or death occurs. This is called time on treatment.

    The study also measures progression-free survival, which means the time from the start of treatment until the cancer gets worse or death occurs, whichever happens first.

Who can join the trial?

9 criteria

  • Be at least 18 years old, or be above the legal age of consent in the country where the study is done if that age is higher than 18.
  • Have a confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). “Advanced” means the cancer has grown beyond its original area, and “metastatic” means it has spread to other parts of the body. “Non-squamous” means the cancer is not the squamous cell type.
  • Have a documented activating HER2 mutation based on a local laboratory result. A mutation is a change in a gene, and HER2 is a gene that can help cancer cells grow.
  • Provide an archival tumor tissue sample after randomization so a central laboratory can later confirm the HER2 result. An archival sample means tissue that was already removed and stored from a previous procedure.
  • Have not received any systemic treatment for unresectable, locally advanced, or metastatic disease. “Systemic treatment” means treatment that works throughout the body, such as chemotherapy or targeted therapy.
  • Have at least one measurable non-CNS lesion according to RECIST 1.1. A lesion is an area of cancer, and measurable means it can be measured on scans. “Non-CNS” means outside the brain and spinal cord. RECIST 1.1 is a standard way doctors measure tumor size in studies.
  • Be able to receive treatment with the chosen platinum-based doublet chemotherapy and pembrolizumab according to the product information. Platinum-based doublet chemotherapy means two cancer medicines are given together, and one contains a platinum drug. Pembrolizumab is a medicine that helps the immune system attack cancer.
  • Have an ECOG performance status of 0 or 1. ECOG is a scale that shows how well a person can do daily activities. A score of 0 means fully active, and 1 means only slightly limited in physical activity.
  • Meet any other inclusion requirements not listed here.

Who cannot join the trial?

9 criteria

  • The tumor has a targetable alteration, meaning a change in the cancer that already has an approved treatment available.
  • There is or was leptomeningeal disease, which means cancer cells in the thin layers of tissue that cover the brain and spinal cord.
  • The patient had radiotherapy (treatment with radiation) within 4 weeks before starting the study, except for palliative radiotherapy to areas other than the chest if it was finished at least 2 weeks before treatment starts.
  • The patient had major surgery within 4 weeks before randomization, or major surgery is planned within 6 months after screening. Randomization means being assigned to a treatment group by chance, and screening means the tests done before joining the study.
  • There is any past or current medical condition that, in the investigator’s opinion, could make it hard to follow the study rules or could interfere with checking whether the treatment is safe and works well.
  • The patient has had previous treatment with a HER2-directed agent, which is a medicine that targets the HER2 protein on cancer cells.
  • There are heart or blood vessel problems that the investigator considers clinically important.
  • The patient had a myocardial infarction (heart attack), stroke, or pulmonary embolism (a blood clot in the lungs) within 6 months before randomization.
  • Other exclusion rules also apply.
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Investigated drugs

  • Pemetrexed

    is a cancer medicine given through a vein. In this trial, it is used as part of a standard chemotherapy combination to help treat advanced non-squamous lung cancer.

  • Zongertinib

    is the main study medicine taken by mouth. It is designed to target HER2 changes in the cancer cells, with the goal of slowing or stopping cancer growth while the study checks how safe and tolerable it is.

  • Cisplatin

    is a chemotherapy medicine given through a vein. In this trial, it is one of the platinum-based medicines used with zongertinib to attack cancer cells and help control the disease.

  • Carboplatin

    is a chemotherapy medicine given through a vein. It is another platinum-based treatment option in the study, used with zongertinib to treat the cancer and to compare how well the combination is tolerated.

  • Pembrolizumab

    is an immunotherapy medicine given through a vein. In this trial, it may be added to zongertinib and chemotherapy to help the immune system recognize and fight the cancer cells more effectively.

What is already known about the treatment

  • Pemetrexed

    Pemetrexed is given as an intravenous infusion, meaning it is delivered through a vein by a healthcare professional. It is a well-known cancer medicine used in the treatment of non-small cell lung cancer, especially in combination with other drugs. It belongs to a group of medicines that block the making of DNA and RNA in cancer cells by stopping key enzymes needed for cell growth, which helps slow or stop tumor growth.

  • Zongertinib

    Zongertinib is taken by mouth as a film-coated tablet. It is an investigational medicine in current medical research and is being studied for cancers with specific HER2 changes, including non-squamous non-small cell lung cancer. It works by blocking the HER2 signal inside cancer cells, which can reduce the signals that tell the cells to grow and survive, and it is classified as a targeted cancer therapy, more specifically a HER2 inhibitor.

  • Cisplatin

    Cisplatin is given as an intravenous infusion through a vein. It is a long-established and widely used cancer medicine, especially in lung cancer and many other solid tumors. It works by damaging the DNA of cancer cells so they cannot divide and grow properly, and it is classified as a platinum-based chemotherapy medicine.

  • Carboplatin

    Carboplatin is given as an intravenous infusion through a vein. It is a well-established cancer medicine used in many cancers, including non-small cell lung cancer, often as part of combination treatment. It works by attaching to the DNA of cancer cells and making it hard for them to copy themselves, which slows cell growth and leads to cell death, and it is classified as a platinum-based chemotherapy medicine.

  • Pembrolizumab

    Pembrolizumab is given as an intravenous infusion through a vein. It is a widely used and well-studied cancer medicine that is approved for several cancers, including certain cases of non-small cell lung cancer. It works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more strongly, and it is classified as an immune checkpoint inhibitor.

Investigated diseases

Non-Small Cell Lung Cancer - A cancer that starts in the tissues of the lung and includes several common types, such as adenocarcinoma and squamous cell carcinoma. It usually begins as a growing mass in the lung and can spread to nearby lymph nodes and other parts of the body. In locally advanced disease, it has grown into nearby structures or lymph nodes near the chest. In metastatic disease, it has spread to distant organs or tissues beyond the lung.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523567-38-00Protocol code1479-0044Estimated enrolment60 patientsSponsorBoehringer Ingelheim Espana S.A.

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