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Study of BNT327 with etoposide and carboplatin compared to atezolizumab with etoposide and carboplatin for patients with untreated extensive-stage small-cell lung cancer

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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 extensive-stage small-cell lung cancer in people who have not yet received treatment for their disease. Small-cell lung cancer is a type of lung cancer that grows and spreads quickly, and extensive-stage means the cancer has spread beyond one lung and nearby lymph nodes. The study will compare two different treatment approaches. One group will receive an investigational medicine called BNT327 combined with chemotherapy drugs etoposide and carboplatin. The other group will receive atezolizumab, which is an already approved medicine, combined with the same chemotherapy drugs etoposide and carboplatin. All medications in this study are given through an infusion into a vein. Some participants may also receive cisplatin as an alternative chemotherapy drug instead of carboplatin during the treatment period.

The purpose of this study is to compare how well BNT327 works compared to atezolizumab when each is given with chemotherapy, specifically by looking at how long participants live after starting treatment. The study will also examine how long participants live without their cancer getting worse, how many participants see their tumors shrink or disappear, and how long these responses last. Additionally, the study will monitor side effects and how the treatments affect quality of life and cancer-related symptoms such as coughing and shortness of breath.

This is a randomized study, which means participants will be assigned by chance to receive either BNT327 with chemotherapy or atezolizumab with chemotherapy. The study is double-blinded, meaning neither the participants nor their doctors will know which treatment group they are in during the study. Participants will receive treatment for up to 48 weeks or longer depending on how they respond to the treatment. Throughout the study, participants will have regular visits where their health, tumor size, and any side effects will be monitored through physical examinations, blood tests, imaging scans, and questionnaires about their well-being and symptoms.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Upon joining the trial, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures fair distribution of participants.

    One group will receive BNT327 combined with chemotherapy (etoposide and carboplatin). The other group will receive atezolizumab combined with the same chemotherapy drugs.

    Neither you nor your doctor will know which treatment group you are in. This is called a double-blinded trial and helps ensure accurate results.

  2. Step 2

    Induction period with combination treatment

    You will receive treatment through intravenous infusion, which means the medication will be delivered directly into your vein.

    The treatment consists of either BNT327 or atezolizumab combined with two chemotherapy drugs: etoposide and either carboplatin or cisplatin.

    All medications will be administered as infusions into your vein during scheduled visits to the treatment facility.

    This combination treatment phase will continue for a specified number of cycles as determined by the trial protocol.

  3. Step 3

    Maintenance treatment phase

    After completing the initial combination treatment phase, you will continue receiving either BNT327 or atezolizumab alone, without the chemotherapy drugs.

    This maintenance treatment will be given through intravenous infusion at regular intervals.

    The treatment will continue until your disease progresses, unacceptable side effects occur, or other reasons require stopping the treatment.

  4. Step 4

    Regular monitoring and assessments

    Throughout the trial, you will have regular medical examinations and tests to monitor your health and how the treatment is working.

    Blood tests will be performed to check your blood cell counts, liver function, and kidney function.

    Imaging scans will be conducted at scheduled intervals to assess your tumor size and whether the cancer has progressed.

    You will be asked to complete questionnaires about your quality of life, physical functioning, and symptoms such as coughing, shortness of breath, and other lung cancer-related issues.

    Any side effects or health changes you experience will be carefully recorded and assessed.

  5. Step 5

    Contraception and reproductive precautions

    If you are a woman of childbearing potential, you must use a highly effective form of contraception starting from your first visit and continuing until 6 months after your last dose of trial treatment, or 7 months after the last dose of cisplatin if you received it, whichever is later.

    If you are a man who is sexually active with a female partner and have not had a vasectomy, you must use condoms and your partner must also use highly effective contraception during the same time period.

    You must not donate or store sperm, eggs, or other reproductive cells for assisted reproduction purposes during the trial and for the same time period after your last treatment dose.

  6. Step 6

    Follow-up after treatment

    After you stop receiving trial treatment, you will continue to be monitored for your overall health and survival.

    Information about any subsequent cancer treatments you receive after the trial treatment will be collected.

    Your participation in the follow-up phase helps assess the long-term effectiveness of the treatment.

Who can join the trial?

13 criteria

  • You must be able to understand the study information and provide written agreement to participate before any study procedures begin.
  • If you are a woman who can become pregnant, you must have a negative pregnancy test within 7 days before starting the study treatment.
  • If you are a woman who can become pregnant, you must agree to use a highly reliable birth control method (a method that prevents pregnancy very effectively) from the screening visit until 6 months after your last dose of study treatment, or 7 months after the last dose of cisplatin if you receive it, whichever is later.
  • If you are a man who is sexually active with a woman who can become pregnant and you have not had a vasectomy (a surgical procedure that prevents a man from causing pregnancy), you must agree to use condoms and ask your partner to use a highly reliable birth control method from the screening visit until 6 months after your last dose of study treatment, or 7 months after the last dose of cisplatin if you receive it, whichever is later.
  • You must agree not to donate or store sperm, eggs, or other reproductive cells for the purpose of having children during the study, starting at screening and continuing until 6 months after your last dose of study treatment, or 7 months after the last dose of cisplatin if you receive it, whichever is later.
  • You must be willing and able to attend all scheduled visits, follow the treatment plan, complete all planned tests and assessments, and follow other study requirements and instructions.
  • You must be at least 18 years old at the time you agree to participate.
  • You must have extensive-stage small-cell lung cancer (a type of lung cancer that has spread beyond one lung) that has been confirmed by tissue or cell examination under a microscope.
  • You must not have received any previous treatment with medications that travel through your bloodstream to treat your extensive-stage small-cell lung cancer.
  • You must have at least one tumor that can be measured using imaging tests according to specific measurement guidelines called RECIST v1.1.
  • You must have an ECOG performance status (a measure of how well you can perform daily activities) of 0 or 1, meaning you are fully active or have some restrictions but can still perform light work.
  • You must weigh at least 40 kilograms (approximately 88 pounds).
  • You must have adequate blood cell counts, blood clotting ability, and proper functioning of your liver and kidneys as shown by laboratory tests.

Who cannot join the trial?

4 criteria

  • The study information does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the clinical trial
  • Without detailed exclusion criteria listed, patients interested in this study would need to have their individual medical situation reviewed by the research team to determine if they are suitable candidates
  • Generally, clinical trials may exclude patients based on factors such as other serious medical conditions, previous treatments, laboratory test results, or medications that could interfere with the study
  • The specific reasons for not being able to join this particular study have not been provided in the available trial information
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Investigated drugs

  • BNT327

    is an investigational medication being tested in this clinical trial. It is given together with chemotherapy drugs to treat extensive-stage small-cell lung cancer in patients who have not received treatment before. This medication is being studied to see if it can help patients live longer when combined with standard chemotherapy.

  • Etoposide

    is a chemotherapy medication used to treat various types of cancer, including lung cancer. It works by stopping cancer cells from growing and dividing. In this trial, it is given as part of the standard chemotherapy treatment along with another chemotherapy drug.

  • Carboplatin

    is a chemotherapy medication that helps destroy cancer cells. It is commonly used to treat lung cancer and other types of cancer. In this study, it is used together with etoposide as the chemotherapy portion of the treatment.

  • Atezolizumab

    is an approved cancer medication that helps the body's immune system fight cancer cells. It is given together with chemotherapy drugs and is being used as the comparison treatment in this trial to see how it compares to the investigational medication BNT327.

What is already known about the treatment

  • BNT327

    BNT327 is an investigational medication currently being studied in clinical trials for the treatment of extensive-stage small-cell lung cancer as a first-line therapy. It is administered intravenously in combination with standard chemotherapy drugs (etoposide and carboplatin) and works by targeting specific molecules on cancer cells to help the immune system recognize and attack the tumor more effectively. This medication belongs to a class of drugs called immunotherapies, which enhance the body's natural defense system to fight cancer. In this trial, BNT327 is being compared to another immunotherapy called atezolizumab to determine which treatment provides better survival outcomes for patients with this aggressive form of lung cancer.

  • Atezolizumab

    Atezolizumab is an approved immunotherapy medication that is given through an intravenous infusion and is currently used in clinical practice for treating various types of cancer, including extensive-stage small-cell lung cancer. It works by blocking a protein called PD-L1 on cancer cells, which normally prevents the immune system from attacking the tumor, thereby allowing the body's immune cells to better recognize and destroy cancer cells. This medication belongs to a class of drugs known as immune checkpoint inhibitors, which remove the "brakes" on the immune system to help it fight cancer more effectively. In this clinical trial, atezolizumab combined with chemotherapy serves as the comparison treatment to evaluate the effectiveness of the new investigational drug BNT327.

Investigated diseases

Extensive-Stage Small-Cell Lung Cancer – This is an advanced form of small-cell lung cancer, which is a type of cancer that begins in the lungs and grows rapidly. In the extensive stage, the cancer has spread beyond one lung to the other lung, to lymph nodes on the other side of the chest, or to distant parts of the body. Small-cell lung cancer develops from cells in the airways and tends to grow and multiply quickly. The cancer cells are small in size when viewed under a microscope, which is how this type gets its name. As the disease progresses, it can affect breathing and other body functions as it spreads to different organs. This form of lung cancer is often associated with smoking and typically affects the bronchi, which are the main air passages in the lungs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515765-34-00Protocol codeBNT327-03Estimated enrolment664 patientsSponsorBioNTech SE

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