RecruitingPHASE3INTERVENTIONAL

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

This study is for people with small-cell lung cancer that has spread to other parts of the body and hasn't been treated yet. Researchers want to compare a new drug called Pumitamig, given with standard chemotherapy (etoposide and carboplatin), against another common treatment, Atezolizumab, also with the same chemotherapy. They will be looking at how safe each treatment is and how well it works. This is a "Phase III" study, meaning it's a large trial to confirm the treatment's benefits. Participants will be randomly assigned to receive one of the treatments. The goal is to find better ways to treat this type of lung cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

BioNTech SE

Enrolment target

621

Start

03 Feb 2025

Estimated completion

01 Mar 2029

Extensive-stage Small-cell Lung Cancer

What is this study about?

This study is looking into a new treatment for a type of lung cancer called "extensive-stage small-cell lung cancer." This means the cancer has spread beyond its original location. If you have this type of cancer and haven't had any treatment for it yet, this study might be for you.

The main goal is to compare two different treatment approaches. One approach involves a new medicine called Pumitamig, given along with standard chemotherapy drugs (specific combinations of etoposide and either carboplatin or cisplatin). The other approach is a widely used treatment called Atezolizumab, also given with the same chemotherapy drugs. Doctors want to see if the new Pumitamig combination is safer and more effective than the Atezolizumab combination.

This is a "Phase III" clinical trial, which means it's a big, important study that takes place in many hospitals. It helps doctors decide if a new treatment should become a standard option. Participants will be randomly assigned to one of the treatment groups, like flipping a coin, so that the comparison is fair. Neither you nor your doctor will know which treatment you are receiving, which helps ensure the results are unbiased.

Key takeaways

It's a study for untreated, advanced small-cell lung cancer.
Compares a new drug (Pumitamig) + chemo vs. standard drug (Atezolizumab) + chemo.
It's a large, important 'Phase III' trial.
Participation involves regular hospital visits and long-term follow-up.
You will be randomly assigned to a treatment group.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must have small-cell lung cancer that has spread and hasn't had any prior treatment. If you had treatment for an earlier stage of this cancer with radiation and chemotherapy, you might still be able to join if it was at least six months ago and your cancer has now progressed to the advanced stage.

You also need to be generally well enough to take part, with a good level of physical activity. Doctors will check your blood tests to make sure your vital organs are working properly. If you have other types of SCLC combined with different cancer cells, or if you've recently had certain other treatments like specific medications or radiation to a wide area, you likely won't be able to join.

Quick self-check

Is my small-cell lung cancer considered 'extensive-stage' (has it spread)?
Have I not had any previous treatment specifically for this advanced small-cell lung cancer?
Am I generally well and able to carry out most daily activities?
Do doctors confirm my organs (like blood, liver, kidneys) are working well enough?
Do I have at least one measurable area of cancer the doctors can track?
Have I not had certain other treatments recently, like extensive radiation?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, there will be two main periods: a screening period which lasts up to 21 days to check if you're suitable for the study. Then, you'll start your assigned treatment. This involves an "induction period" followed by a "maintenance period." You'll continue treatment until your cancer gets worse, you experience side effects that are too difficult to manage, you choose to stop, the study ends, or for up to two years, whichever happens first.

During this time, you'll have regular hospital visits for your treatments and to check how you're doing and if there are any side effects. After your treatment period ends, you'll have two more safety follow-up visits. After that, researchers will continue to check in with you periodically to see how you're doing in the long term, focusing on your survival.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment before it's widely available, which might improve your health. However, like all medical treatments, there are potential risks, and you may experience side effects from the study drugs. Some side effects might be serious. There's also no guarantee that the new treatment will be better than standard care. You can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (202)

ACRC Arizona Clinical Research Center
Tucson, United States· Recruiting
Clermont Oncology Center
Clermont, United States· Terminated
Cancer Care Centers of Brevard, Inc
Palm Bay, United States· Recruiting
Illinois Cancer Specialists
Niles, United States· Recruiting
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, United States· Recruiting
McFarland Clinic
Ames, United States· Recruiting
Helen G. Nassif Community Cancer Center
Cedar Rapids, United States· Recruiting
Baptist Health Hardin Cancer Center
Elizabethtown, United States· Recruiting
Frederick Health Hospital- James M Stockman Cancer Institute
Frederick, United States· Recruiting
Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center
Burlington, United States· Recruiting
Baptist Cancer Center
Southaven, United States· Recruiting
Washington University School of Medicine
St Louis, United States· Recruiting

+190 more sites — see the official record for the full list.

Common questions

What does 'extensive-stage' mean?

It means the small-cell lung cancer has spread from where it started to other parts of your body.

What is 'chemotherapy'?

Chemotherapy is a type of medicine that uses strong chemicals to kill fast-growing cancer cells.

Will I know which treatment I'm getting?

No, this is a "double-blind" study, meaning neither you nor your doctor will know which specific treatment you are receiving. This helps make the study fair.

How long will I be in the study?

Treatment can last for up to two years, or until your cancer gets worse or side effects become too much. There will then be follow-up visits to check on your health.

Can I stop the study at any time?

Yes, you have the right to withdraw from the study at any point, and it will not affect 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.