Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Safety and Effectiveness of BNT327 and Docetaxel for Patients with Advanced Non-Small Cell Lung Cancer After Chemoimmunotherapy

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is investigating a treatment for non-small cell lung cancer (NSCLC) that has reached an advanced stage (stage IV) or has recurred after previous treatment. The treatment being tested combines an investigational drug called BNT327 with docetaxel, which is a type of chemotherapy medication. The study focuses on patients whose cancer has progressed after receiving a first-line treatment that combined chemotherapy with immunotherapy (treatment that helps the immune system fight cancer).

The purpose of this study is to assess how safe and effective the combination of BNT327 and docetaxel is for treating advanced non-small cell lung cancer. The study is designed as a Phase II trial, which means it follows initial safety testing and aims to further evaluate the treatment's safety while also beginning to measure how well it works against the cancer.

During the study, participants will receive the combination treatment and be monitored for side effects. Doctors will also track how the cancer responds to treatment by measuring whether tumors shrink, remain stable, or continue to grow. Various assessments will be conducted throughout the study to evaluate the treatment's effectiveness and to monitor participants' overall health and survival.

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

    Screening and Confirmation of Eligibility

    You will be confirmed to have stage IV or recurrent non-small cell lung cancer (NSCLC) that has progressed after receiving first-line treatment with immunotherapy and platinum-based chemotherapy.

    Your cancer must have at least one measurable tumor lesion, and you must have documentation of your PD-L1 status (a protein marker) from previous testing.

    Your performance status will be evaluated using the ECOG scale (a measure of how cancer affects daily activities) and must be rated 0 or 1, meaning you can perform most daily activities with minimal assistance.

    Blood tests will be conducted to confirm you have adequate organ function before starting the trial treatment.

  2. Step 2

    Trial Treatment Period

    The trial is divided into two parts. Some patients will participate in Part 1 (initial safety assessment) while others will join Part 2.

    You will receive a combination of BNT327 (an investigational medicine) and docetaxel (a standard chemotherapy medication).

    BNT327 will be given as an intravenous infusion (through a vein).

    Docetaxel will be given at 20 mg/ml as an intravenous infusion.

    Treatment will be administered in cycles, continuing until your disease progresses, you experience unacceptable side effects, or you decide to withdraw from the study.

  3. Step 3

    Monitoring During Treatment

    Throughout the treatment period, you will have regular tumor assessments using imaging scans to evaluate how your cancer is responding to treatment.

    Your doctor will assess your response using standardized criteria called RECIST v1.1, which measures changes in tumor size.

    Blood samples will be collected to measure the amount of BNT327 in your bloodstream (pharmacokinetics) and to check if your body develops antibodies against BNT327.

    You will be monitored for side effects, which will be graded according to standardized criteria (CTCAE).

    If you experience certain severe side effects, your treatment may be interrupted, the dose may be reduced, or you may be discontinued from the trial.

  4. Step 4

    Follow-up Period

    After completing or discontinuing treatment, you will attend a safety follow-up visit 90 days after your last dose.

    Your overall health status and any ongoing side effects will be assessed during this visit.

    If you showed a response to treatment, you will continue to be monitored to determine how long the response lasts.

    Your survival status may be followed for up to approximately 2 years from the start of treatment.

  5. Step 5

    End of Trial

    Your participation in the trial will end after completing the follow-up period or earlier if you withdraw consent.

    The entire clinical trial is expected to run until October 2028, although your individual participation will likely be shorter.

Who can join the trial?

9 criteria

  • Have a confirmed diagnosis of Stage IV Non-small Cell Lung Cancer (NSCLC) that has gotten worse after receiving one prior treatment that included both immunotherapy (treatment that helps your immune system fight cancer) and platinum-based chemotherapy.
  • Must have received at least 2 cycles of immunotherapy in your first treatment for advanced cancer.
  • Only one previous immunotherapy-containing treatment is allowed for advanced cancer.
  • If you received immunotherapy as an additional treatment after surgery (adjuvant therapy), at least 6 months must have passed since your last dose before your cancer returned.
  • Must have previous PD-L1 test results available (this is a test that helps determine if immunotherapy might work for your cancer).
  • If your cancer has specific genetic changes that can be targeted with medication, you may enroll if you received the targeted therapy along with immunotherapy as your first treatment.
  • Have at least one measurable tumor that can be tracked during the study according to RECIST v1.1 criteria (a standard way to measure tumor changes).
  • Have good performance status (ECOG score of 0 or 1), meaning you can perform daily activities with little or no assistance.
  • Have adequate organ function (your organs must be working well enough to safely participate in the study).

Who cannot join the trial?

12 criteria

  • You have cancer that has spread to the brain or spinal cord, unless it has been treated and is stable.
  • You have had serious side effects from previous cancer treatments that have not fully resolved.
  • You have been treated with specific cancer medications (docetaxel or other taxanes) before.
  • You have had another type of cancer in the last 3 years (except for certain skin cancers or cervical cancer that have been successfully treated).
  • You have severe heart disease or have had a heart attack in the past 6 months.
  • You have an active infection or inflammation in your lungs.
  • You have an active infection requiring treatment.
  • You have tested positive for HIV, hepatitis B, or hepatitis C (virus infections).
  • You are pregnant or breastfeeding.
  • You have certain nerve problems or severe nerve damage from previous treatments.
  • You have had major surgery within the past 4 weeks.
  • You are currently participating in another clinical trial or have received an investigational drug within the past 4 weeks.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • BNT327

    is an investigational medication being studied for the treatment of non-small cell lung cancer (NSCLC) that has spread or returned after initial treatment. It is designed to be used in combination with docetaxel as a second-line treatment for patients whose cancer has progressed after receiving chemoimmunotherapy.

  • Docetaxel

    is a chemotherapy medication that works by interfering with the ability of cancer cells to divide and grow. It is commonly used to treat various types of cancer, including non-small cell lung cancer. In this trial, docetaxel is being combined with BNT327 to see if the combination provides better results than standard treatments for patients whose cancer has progressed after initial therapy.

What is already known about the treatment

  • BNT327

    An investigational medication being studied in clinical trials for non-small cell lung cancer (NSCLC), specifically for patients whose cancer has progressed after first-line chemoimmunotherapy. It is administered in combination with docetaxel, though the specific form of administration is not specified in the available data. BNT327 is currently in Phase II clinical trials, indicating it has shown preliminary safety and potentially promising results in earlier studies, but is not yet approved for general medical use. While its exact mechanism of action at the molecular level is not described in the provided information, the study aims to assess both its safety and efficacy in treating advanced or metastatic NSCLC as a second-line therapy option.

  • Docetaxel

    A well-established chemotherapy medication administered as an intravenous infusion for various types of cancer, including non-small cell lung cancer (NSCLC). It belongs to the taxane family of drugs and works by interfering with cell division, preventing cancer cells from multiplying by stabilizing the microtubule structures needed for cell division. Docetaxel is approved by regulatory agencies worldwide and is commonly used as a standard second-line treatment for NSCLC. In this clinical trial, it is being studied in combination with the investigational drug BNT327 to potentially enhance treatment outcomes for patients whose cancer has progressed after initial chemoimmunotherapy.

Investigated diseases

Non-small Cell Lung Cancer Non-small Cell Lung Cancer is a type of lung cancer that accounts for about 85% of all lung cancers. It develops from the epithelial cells of the lung and includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The disease typically begins in the cells lining the bronchi and parts of the lung such as the bronchioles or alveoli. As it progresses, the cancer cells can spread locally within the lung, to nearby lymph nodes, and eventually to distant organs through metastasis. Advanced or metastatic NSCLC is characterized by the spread of cancer beyond the lungs to other parts of the body, indicating a progression of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518279-80-00Protocol codeBNT327-07Estimated enrolment60 patientsSponsorBioNTech SE

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.