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A study testing BNT326 and BNT327 with drug combination for safety and effectiveness in people with advanced non-small cell lung cancer

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 examines non-small cell lung cancer, which is an advanced form of lung cancer. The study will test different combinations of investigational medications. These include BNT326 and BNT327, which are experimental drugs given through infusion into a vein. Some participants may also receive standard cancer medications such as paclitaxel, carboplatin, pemetrexed, or pembrolizumab, depending on which part of the study they are in. The purpose of this study is to determine the appropriate dose of BNT326 when combined with BNT327, to assess how safe these medications are when used together, and to evaluate whether this combination treatment may help control the cancer.

The study is divided into different parts. The first part will test different dose levels of the investigational medications to find the most suitable dose for further testing. During this phase, doctors will carefully monitor participants for any side effects. The following parts of the study will test the chosen dose in larger groups of people with advanced non-small cell lung cancer to better understand how well the treatment works and how safe it is. Throughout the study, participants will receive the medications through infusion into a vein. Doctors will regularly check how the cancer responds to treatment using imaging scans and other assessments.

During the study, participants will need to provide a tissue sample from their tumor, either from a previously stored sample or from a new biopsy if needed. The study will track various aspects of participant health and treatment response, including any side effects that occur, whether the cancer shrinks or stops growing, and how long any positive effects last. Blood samples will be collected at different times to measure the levels of the investigational medications in the body and to check whether the immune system develops a response to these medications.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    Your treatment will be assigned based on which part of the trial you are enrolled in. The trial consists of three parts: Part 1 (Dose Escalation), Part 2a (Dose Expansion), and Part 2b (Dose Optimization).

    All parts involve receiving BNT326 in combination with BNT327. These are investigational medications that will be given to you through intravenous infusion, which means they will be administered directly into your vein.

    Depending on your specific treatment group, you may also receive additional medications such as carboplatin, pembrolizumab, pemetrexed, or paclitaxel. All medications are given through intravenous infusion.

  2. Step 2

    Providing tumor tissue sample

    You will need to provide a tumor tissue sample. This can be from previously collected tissue stored from an earlier procedure, known as archival tissue.

    If archival tissue is not available, a fresh biopsy may need to be collected. A biopsy is a procedure where a small sample of tumor tissue is removed for testing. This will only be done if it is medically appropriate for your situation.

  3. Step 3

    Pre-treatment assessments

    Before starting treatment, your organ and bone marrow function will be assessed within 7 days before treatment begins. This involves blood tests to ensure your body can safely receive the medications.

    Your disease status will be evaluated to confirm you have measurable disease. This means your tumor can be measured using imaging scans, following specific criteria known as RECIST v1.1.

  4. Step 4

    Beginning treatment cycles

    You will begin receiving the study medications. BNT326 and BNT327 will be administered as intravenous infusions.

    If you are in Part 1 (Dose Escalation), you will be monitored closely during a specific period called the dose limiting toxicity evaluation period. During this time, your medical team will watch for any serious side effects that might require adjusting the dose.

    The treatment will be given in cycles. The specific dosage, frequency, and duration will depend on which part of the trial you are in and how your body responds to the treatment.

  5. Step 5

    Ongoing monitoring during treatment

    Throughout your treatment, you will be monitored for any adverse events, which are unwanted side effects or health problems that occur during the trial.

    Your medical team will track treatment emergent adverse events, which are any health issues that develop or worsen after you start taking the study medications.

    Blood samples will be collected at various times to measure the levels of the study medications in your body. This is called pharmacokinetic assessment and helps understand how your body processes these medications.

  6. Step 6

    Regular tumor assessments

    Your tumor will be assessed regularly using imaging scans to determine how well the treatment is working.

    The medical team will look for signs of objective response, which includes whether your tumor has shrunk significantly (partial response) or disappeared completely (complete response).

    These assessments will also determine if your disease has remained stable or if there has been tumor progression, meaning the cancer has grown or spread.

  7. Step 7

    Antibody testing

    Blood samples will be taken to check for anti-drug antibodies. These are proteins your immune system might produce in response to the study medications.

    This testing helps determine if your body is developing an immune response to the treatment, which could affect how well the medications work.

  8. Step 8

    Possible dose adjustments

    Depending on how you tolerate the treatment, your dose may need to be interrupted, reduced, or discontinued.

    These adjustments are made based on any adverse events you experience to ensure your safety while receiving treatment.

  9. Step 9

    Continued treatment and follow-up

    You will continue receiving treatment cycles as long as the treatment is benefiting you and you are tolerating it well.

    Your progression-free survival will be tracked, which measures the length of time from starting treatment until your cancer progresses or death occurs.

    Your duration of response will be measured if your tumor responds to treatment. This tracks how long your tumor remains shrunk or stable after responding to the medications.

    Your overall survival will also be followed, which measures the time from starting treatment until death from any cause.

  10. Step 10

    Long-term monitoring

    Even after you stop receiving the study medications, you will continue to be monitored for your health status and disease progression.

    The trial is expected to continue collecting information until approximately January 2029, though your individual participation duration may vary.

Who can join the trial?

6 criteria

  • You must be 18 years of age or older at the time you agree to take part in the study.
  • You must have measurable disease, which means your cancer can be seen and measured on scans according to specific guidelines called RECIST v1.1, a standard way doctors measure tumors.
  • You must provide a sample of your tumor tissue that was collected and stored from a previous procedure. If this is not available, a new sample may need to be taken by biopsy, which is a procedure where a small piece of tissue is removed from your tumor, unless your doctor determines this would not be safe for you.
  • You must have an Eastern Cooperative Oncology Group performance status of 0 or 1, which is a scale doctors use to measure how well you can perform daily activities. A score of 0 means you are fully active, and 1 means you have some symptoms but can still carry out light work.
  • You must have adequate organ and bone marrow function, which means your organs such as liver and kidneys, and your bone marrow that makes blood cells, must be working well enough. This will be checked with blood tests done within 7 days before you join the study.
  • You must have advanced non-small cell lung cancer, which can be either the non-squamous type or the squamous type. Non-small cell lung cancer is a specific kind of lung cancer, and squamous and non-squamous refer to how the cancer cells look under a microscope.

Who cannot join the trial?

4 criteria

  • The study does not provide specific exclusion criteria information in the available data
  • Patients should discuss with their doctor whether they are eligible to participate in this clinical trial for Non-small Cell Lung Cancer, which is a type of cancer that affects the lungs
  • The trial involves testing a combination of two experimental medications called BNT326 and BNT327
  • General exclusion criteria typically exist for clinical trials but are not detailed in the provided information
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Investigated drugs

  • BNT326

    is an investigational medication being studied in combination with another drug for the treatment of advanced non-small cell lung cancer. This medication is being tested to find the right dose that is both safe and effective for patients with this type of cancer.

  • BNT327

    is an investigational medication that is being studied together with BNT326 for treating advanced non-small cell lung cancer. The trial will examine how well this medication works when given in combination and what the best dose should be for patients.

What is already known about the treatment

  • BNT326

    BNT326 is an investigational medication currently being studied in clinical trials for the treatment of advanced non-small cell lung cancer. It is being tested in combination with another experimental drug called BNT327 to evaluate its safety, effectiveness, and how the body processes it. The specific form of administration, exact mechanism of action, and pharmacological classification have not been publicly disclosed as this medication is still in early phase research. This drug is not yet approved for use outside of clinical trials and is being investigated to determine the best dosing strategy for potential future treatment of lung cancer patients.

  • BNT327

    BNT327 is an experimental medication being evaluated in clinical trials as a combination therapy with BNT326 for patients with advanced non-small cell lung cancer. The drug is currently in early-phase testing to assess its safety profile, therapeutic benefits, and optimal dosing when used together with BNT326. Detailed information about its method of administration, molecular mechanism of action, and drug classification remains limited as it is still undergoing investigation. This medication is not yet available for standard medical use and can only be accessed through participation in authorized clinical research studies.

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 begin to grow abnormally and uncontrollably, forming tumors. As the cancer progresses, these abnormal cells can spread to nearby tissues and lymph nodes in the chest. In advanced stages, the cancer may spread to other parts of the body through the bloodstream or lymphatic system, a process called metastasis. The disease can cause symptoms such as persistent cough, chest pain, shortness of breath, and weight loss. Non-small cell lung cancer grows and spreads more slowly compared to small cell lung cancer, but it often goes undetected until it has reached an advanced stage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519344-32-00Protocol codeBNT326-02Estimated enrolment880 patientsSponsorBioNTech SE

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