RecruitingPHASE1, PHASE2INTERVENTIONAL

A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer

This research study is looking at a new combination of two medicines, BNT324 and BNT327, for people who have advanced lung cancer. This includes both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) that has spread or come back. The main goals are to find a safe and effective dose of these medicines when given together. The study will happen in stages, first finding safe doses, then checking which doses work best, and finally looking for early signs that the combination is helping patients. It's a way to explore new treatment options for those with advanced lung cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

BioNTech SE

Enrolment target

594

Start

02 May 2025

Estimated completion

01 Jun 2031

Advanced Lung Cancer

What is this study about?

This study is investigating a new way to treat advanced lung cancer, using two medicines called BNT324 and BNT327 together. This type of cancer has either spread to other parts of the body (advanced/metastatic) or has returned after previous treatment (relapsed/progressive). The study includes people with both main types of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). The scientists want to see if combining these two medicines is safe and how well it works.

Think of the study like a step-by-step process. In the first part, a small group of people will receive different doses of the two medicines to figure out which doses are safe to give together. Once they find these safe dose levels, the next part of the study will test these doses in more people with specific types of lung cancer to see which dose works best and to look for early signs that the treatment is effective. The ultimate goal is to find the best dose that helps patients as much as possible.

This research is important because it could lead to new treatment options for people with advanced lung cancer. By carefully testing these new medicines, doctors can learn more about how they work and if they can improve the lives of patients. It's about exploring every possible avenue to tackle this complex disease.

Key takeaways

This study is testing two new medicines for advanced lung cancer.
It aims to find safe and effective doses of the combined treatments.
It includes both non-small cell and small cell lung cancer types.
Participation involves regular check-ups and monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be at least 18 years old and have lung cancer that has been confirmed by a doctor, specifically advanced cancer that cannot be removed by surgery. Your doctor will check if your cancer has spread or come back after previous treatments. For some parts of the study, if your cancer has certain genetic changes and you've already had targeted therapy, you might be eligible.

There are also some things that would prevent you from joining. For example, if you've previously had a specific type of treatment called B7-H3 targeted therapy, you wouldn't be able to participate. Also, if you're a good candidate for other local treatments like surgery or radiotherapy that could offer a complete cure, this study might not be right for you. Your blood test results also need to be within certain healthy ranges.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced lung cancer (NSCLC or SCLC) that cannot be surgically removed or has spread?
Have you not had a treatment called B7-H3 targeted therapy before?
Does your cancer currently show signs that can be measured (like on a scan)?
Are you well enough to participate in a clinical study (your doctor will check this)?
Have you discussed with your doctor if alternative local treatments (like surgery aiming for a cure) are suitable for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several stages. First, there's a screening period to check if you're suitable for the study. If you are, you'll then enter a treatment period where you'll receive the study medicines, BNT324 and BNT327, on a regular schedule. Your doctors will regularly monitor your health and the effects of the treatment through various tests and check-ups. After your treatment ends, there will be a safety follow-up period to keep an eye on your health, and then a longer-term follow-up to track your well-being over time. The exact number of visits and the full length of your participation will depend on the specific stage of the study you are in and how you respond to treatment, but it will involve regular appointments over a period of time.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. While this study may not directly help you, it could lead to new knowledge that benefits future patients. The potential risks involve possible side effects from the new medicines, which will be carefully monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (76)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mayo Clinic Arizona
Verified postcode
Phoenix, United States· Recruiting
Precision NextGen Oncology and Research Center
Verified postcode
Beverly Hills, United States· Recruiting
Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
UCLA - David Geffen School of Medicine
Verified postcode
Santa Monica, United States· Recruiting
University of Colorado Cancer Center
Verified postcode
Aurora, United States· Recruiting
Mayo Clinic in Florida
Verified postcode
Jacksonville, United States· Recruiting
University of Iowa Hospitals & Clinics PARENT
Verified postcode
Iowa City, United States· Recruiting
Mayo Clinic-Rochester
Verified postcode
Rochester, United States· Recruiting
John Theurer Cancer Center at Hackensack UMC
Verified postcode
Hackensack, United States· Recruiting
Memorial Sloan Kettering Cancer Center (MSKCC)
Verified postcode
New York, United States· Recruiting
Icahn School of Medicine at Mount Sinai PRIME
Verified postcode
New York, United States· Recruiting
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center
Verified postcode
Cleveland, United States· Recruiting

Common questions

What kind of lung cancer is this study for?

This study is for people with advanced non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) that has either spread or come back.

What are BNT324 and BNT327?

These are two new experimental medicines being tested together to see if they can effectively treat advanced lung cancer.

Will I know which dose I am receiving?

In some parts of the study, you might be assigned to one of two different dose levels, but the research team will decide the best dose based on safety and early effectiveness data.

How long will I be in the study?

Your involvement includes screening, a treatment period, and follow-up periods. The exact length depends on how you respond to treatment and the specific part of the study you're in.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point and for any reason, without it affecting your future medical care.

How to find out more

BioNTech clinical trials patient information

patients@biontech.de +49 6131 9084 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.