Active not recruitingPHASE2INTERVENTIONAL

Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy

This research is a Phase 2 study for people with a type of lung cancer called small-cell lung cancer. The study is investigating a new treatment called BNT327, given alongside standard chemotherapy medicines like etoposide, carboplatin, paclitaxel, or topotecan. Researchers want to find out if BNT327 is safe and helps to control the cancer. The study involves different groups of patients: some whose cancer is widespread from the start, and others whose cancer has progressed after initial treatments. By looking at different combinations and doses, the doctors hope to find the best way to use this new treatment in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

BioNTech SE

Enrolment target

110

Start

05 Aug 2024

Estimated completion

01 May 2028

Extensive-stage Small-cell Lung Cancer Small-cell Lung Cancer

What is this study about?

This study is all about a new investigational medicine called BNT327, which doctors are hoping could help people with small-cell lung cancer. This type of lung cancer can sometimes be aggressive, and researchers are always looking for better ways to treat it. In this study, BNT327 is being given in combination with common chemotherapy drugs that are already used for this cancer. The main goal is to check how safe this new combination is and to see how well it works against the cancer.

There are different groups of people in the study depending on their specific cancer situation. Some participants have widespread small-cell lung cancer that hasn't been treated before. Other participants have small-cell lung cancer that has grown or come back after they've already had one or two other types of treatment. By studying these different groups, the researchers can learn more about how BNT327 works with different chemotherapy medicines and at different stages of the illness.

The doctors will also be looking to see what the best dose of BNT327 is. This helps them to figure out the safest and most effective way to use this medicine for future patients. Participants will continue treatment for as long as it's helping and they are tolerating it, or for a maximum of two years. This kind of research is really important for developing new options for treating small-cell lung cancer.

Key takeaways

This study is for people with small-cell lung cancer.
It tests a new medicine, BNT327, combined with chemotherapy.
Researchers want to find out how safe and effective this new combination is.
There are different groups for people with widespread or previously treated cancer.
Participation involves regular hospital visits for treatment and check-ups.
You can leave the study at any time.

Who may be eligible?

To join this study, you must be 18 years or older. The study has different groups depending on your specific situation with small-cell lung cancer.

If you are in group 1, you must have widespread small-cell lung cancer that hasn't been treated with chemotherapy or radiotherapy yet. If you had limited small-cell lung cancer treated with radiotherapy in the past, at least 6 months must have passed since that treatment.

If you are in group 2 or 3, your small-cell lung cancer must have grown or come back after you've already had one or two courses of chemotherapy. You also need to have at least one measurable area of cancer that doctors can track during the study.

Quick self-check

Are you 18 years old or older?
Do you have small-cell lung cancer?
Has your widespread small-cell lung cancer not been treated before, OR has your small-cell lung cancer returned after 1-2 previous chemotherapy treatments?
Are you able to attend regular hospital appointments for treatment and tests?
Do you have at least one area of cancer that doctors can measure and track?

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

What does participation involve?

If you decide to join this study, you'll be assigned to one of the treatment groups. This will involve you taking the new medicine BNT327 along with specific chemotherapy drugs. You'll receive these treatments until your cancer grows, if the side effects become too much, or if you decide to stop participating.

The study involves regular visits to the hospital or clinic for treatments, check-ups, blood tests, and scans. These assessments help the doctors to monitor your health, how the treatment is working, and if there are any side effects. You'll be part of the study for as long as the treatment is beneficial or up to a maximum of two years, whichever comes first.

Potential risks and benefits

Being part of a clinical trial means you might get access to a new treatment before it's widely available. While BNT327 is being tested to see if it's safe and effective, there's no guarantee it will help your cancer. There's also a chance you could experience side effects from the new medicine or the chemotherapy, some of which could be serious. The research team will carefully monitor you throughout the study. Remember, joining is entirely your choice, and you can stop participating at any time, for any reason, without it affecting your medical care.

Locations (64)

Alaska Oncology and Hematology, LLC
Anchorage, United States
Valkyrie Clinical Trials
Los Angeles, United States
Clermont Oncology Center
Clermont, United States
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, United States
Tallahassee Memorial Physician Partners - Cancer & Hematology Specialists
Tallahassee, United States
Carle Foundation Hospital d/b/a Carle Cancer Center
Urbana, United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, United States
University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center)
Lexington, United States
Allina Health
Minneapolis, United States
SSM Health Cancer Care - St. Clare
Fenton, United States
Nebraska Hematology-Oncology (NHO) - Lincoln
Lincoln, United States
Clinical Research Alliance Inc
Westbury, United States

+52 more sites — see the official record for the full list.

Common questions

What is BNT327?

BNT327 is a new experimental medicine being tested in this study to see if it can help treat small-cell lung cancer.

What is small-cell lung cancer?

Small-cell lung cancer is a type of lung cancer that can grow quickly. This study is looking for new ways to treat it.

Will I definitely get the new medicine?

Yes, if you join this study, you will receive BNT327 along with other chemotherapy drugs.

How long will I be in the study?

You will stay in the study for as long as the treatment is helping you or for up to two years, whichever happens first.

What are 'Phase 2' studies?

Phase 2 studies are designed to see if a new treatment is safe and effective in a larger group of people, after initial safety tests.