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Study on the Safety and Effectiveness of BNT327 with Chemotherapy for Patients with Non-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 focused on studying the treatment of non-small cell lung cancer, a common type of lung cancer. The study will explore the use of an investigational therapy called BNT327 in combination with chemotherapy and other investigational agents. Chemotherapy involves using drugs to kill cancer cells, and in this study, the drugs include paclitaxel, pembrolizumab (also known as Keytruda), pemetrexed, and carboplatin. These medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and effectiveness of BNT327 when used with chemotherapy. The trial is divided into two phases: Phase II and Phase III. In Phase II, the focus is on assessing how safe and tolerable BNT327 is at different dose levels when combined with chemotherapy. In Phase III, the study will compare the effectiveness of BNT327 combined with chemotherapy to the combination of pembrolizumab and chemotherapy. The study will also look at how these treatments affect the progression of the disease and overall survival of participants.

Participants in the study will receive treatment over a period of time, with regular follow-up visits to monitor their health and the effects of the treatment. The study aims to provide valuable information on the potential benefits and risks of using BNT327 in treating non-small cell lung cancer, which could lead to new treatment options for patients in the future.

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

    Initial visit

    Upon joining the clinical trial, you will attend an initial visit. During this visit, medical staff will review your medical history and perform a physical examination to ensure you meet the trial's eligibility criteria.

    You will be informed about the trial procedures, potential risks, and benefits. You will be asked to provide written consent to participate in the study.

  2. Step 2

    Screening tests

    You will undergo various screening tests to confirm your eligibility. These tests may include blood tests, imaging scans, and other assessments to evaluate your overall health and the status of your lung cancer.

  3. Step 3

    Treatment phase

    If eligible, you will begin the treatment phase. This involves receiving the investigational therapy BNT327 in combination with chemotherapy drugs such as paclitaxel, pembrolizumab, pemetrexed, and carboplatin.

    These medications are administered as a solution for infusion, which means they are given directly into your bloodstream through a vein. The specific dosage and frequency will be determined by the study protocol and your healthcare team.

  4. Step 4

    Regular follow-up visits

    Throughout the trial, you will have regular follow-up visits. During these visits, medical staff will monitor your health, assess the effectiveness of the treatment, and check for any side effects.

    You may be required to undergo additional tests and assessments to track your progress and ensure your safety.

  5. Step 5

    End of treatment

    Once the treatment phase is complete, you will have a final assessment to evaluate the overall impact of the therapy on your lung cancer.

    You will be informed about any further steps or follow-up care that may be necessary after the trial concludes.

  6. Step 6

    90-day follow-up

    After completing the treatment, there will be a 90-day follow-up period. During this time, you will continue to be monitored for any long-term effects or changes in your health status.

    This follow-up is crucial to ensure your well-being and to gather additional data on the investigational therapy's safety and effectiveness.

Who can join the trial?

12 criteria

  • Are able to give informed consent and have given written consent. This means you understand the study and agree to participate.
  • Are a person of child-bearing potential (POCBP) who agrees to use a highly effective form of birth control and require their male partners to use barrier methods like condoms, starting from the screening visit until 6 months after the last dose of the study drug.
  • Are men who are sterile or, if potentially fertile and sexually active with a partner who can have children, agree to use condoms and ask their partners to use a highly effective form of birth control during the study, starting from giving consent until 6 months after the last dose of the study drug.
  • Agree not to donate or freeze sperm or eggs for assisted reproduction during the study, starting at screening and until 6 months after the last dose of the study drug.
  • Are willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and assessments. This means you can understand and follow the study instructions.
  • Are male or female, aged 18 years or older at the time of giving consent.
  • Have a confirmed diagnosis of Stage IIIB or IIIC non-small cell lung cancer that cannot be treated with surgery or radiotherapy, or Stage IV non-small cell lung cancer without specific genetic mutations (EGFR or ALK).
  • Have at least one measurable tumor based on specific medical criteria (RECIST v1.1).
  • Have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
  • Have a life expectancy of more than 3 months.
  • Have adequate organ function, meaning your blood, liver, kidneys, and blood clotting are working well enough for the study.
  • Are a person of child-bearing potential who has a negative pregnancy test at screening and before each dose of the study drug.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides non-small cell lung cancer cannot participate.
  • Patients who have had a different cancer treatment within the last 4 weeks are not eligible.
  • Patients with severe heart problems, such as heart failure or a recent heart attack, cannot join the study.
  • Patients with uncontrolled high blood pressure are excluded.
  • Patients with active infections, such as untreated bacterial or viral infections, cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible.
  • Patients with known allergies to the study drugs or similar drugs cannot join.
  • Patients with a history of severe allergic reactions to any medication are excluded.
  • Patients with significant liver or kidney disease cannot participate.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
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Investigated drugs

  • BNT327

    is an investigational medication being studied for its potential use in treating non-small cell lung cancer. In this clinical trial, it is being tested in combination with chemotherapy to see how well it works and how safe it is for patients. The trial aims to find out if this new medication can help improve the treatment outcomes for patients with this type of lung cancer.

  • Pembrolizumab

    is a medication that is already used in the treatment of various types of cancer, including non-small cell lung cancer. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, pembrolizumab is being used in combination with chemotherapy to compare its effectiveness against the new investigational medication, BNT327, also combined with chemotherapy. The goal is to determine which treatment option provides better results for patients.

What is already known about the treatment

BNT327 – BNT327 is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its potential use in treating non-small cell lung cancer, a common type of lung cancer. The main goal of these trials is to assess how safe and effective BNT327 is when used alongside standard chemotherapy treatments. At the molecular level, BNT327 works by targeting specific proteins on cancer cells, which may help to slow down or stop the growth of the cancer. It is classified as an investigational drug, meaning it is still being tested and is not yet approved for general medical use.

Investigated diseases

Non-small cell lung cancer – Non-small cell lung cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease often progresses slowly, with symptoms that may include a persistent cough, chest pain, and shortness of breath. As it advances, it can lead to more severe respiratory issues and may affect other organs. The progression of the disease can vary depending on the subtype and individual patient factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-515764-31-00Protocol codeBNT327-06Estimated enrolment1 577 patientsSponsorBioNTech SE

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).