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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Iaxksnud Cahwry Dowkkxwyoavwtfoyo	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	04.08.2025

Trial locations

Investigated drugs:

Docetaxel

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.

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 ID:

2024-518279-80-00

Protocol code:

BNT327-07

NCT ID:

NCT06841055

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?