A Phase III, multi-center, open-label, randomised, controlled trial of intravenous obrixtamig in combination with carboplatin and etoposide vs. carboplatin and etoposide as first-line therapy in DLL3-positive patients with unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas.
This important trial is testing a new treatment called obrixtamig for people in the UK with advanced or spread neuroendocrine cancer that started outside the lungs and can't be removed by surgery. This particular type of cancer has a marker called DLL3. Participants will be randomly assigned to receive either the new drug obrixtamig along with standard chemotherapy (carboplatin and etoposide), or just the standard chemotherapy. The main goal is to see if the new combination helps people live longer. Researchers will also look at how long people live without their cancer growing, how their physical health changes, and any side effects. This is a Phase 3 study, meaning it's a large trial to confirm if the new treatment is better than the current standard.
At a glance
What is this study about?
This study is for adults with a type of cancer called neuroendocrine carcinoma. This is a cancer that starts in special cells throughout the body and can occur in many different organs. In this study, we're focusing on neuroendocrine cancers that have spread or are advanced and can't be removed by surgery, and did not start in the lungs. Importantly, the cancer must also have a specific marker called DLL3.
The trial aims to see if adding a new drug, called obrixtamig, to a standard chemotherapy treatment (carboplatin and etoposide) can help people live longer and improve their health compared to receiving just the standard chemotherapy. Obrixtamig is given into a vein, like an infusion.
Researchers will carefully compare both groups of patients. They will track key information, such as how long people live, how long it takes for the cancer to grow or spread, how the treatment affects physical everyday activities, and any side effects that might occur. This is a "Phase 3" study, which means it's a large-scale trial designed to confirm if the new treatment is safe and effective enough to potentially become a new standard treatment.
Key takeaways
- This study tests a new drug (obrixtamig) alongside standard chemotherapy.
- It's for specific advanced neuroendocrine cancers with a 'DLL3' marker.
- The main goal is to see if the new combination helps people live longer.
- You'll either get the new combination or standard chemotherapy.
- Your doctor will decide if this study might be suitable for you.
- This is a large Phase 3 study, aiming to confirm treatment effectiveness.
Who may be eligible?
To join this study, you must be 18 years old or older. The study is open to both men and women.
Your doctor will check if you have advanced or spread neuroendocrine cancer that started outside your lungs and cannot be removed by surgery.
Also, a very specific test must show that your cancer has a marker called DLL3. Your doctor will arrange this test if they think you might be suitable for the study.
- Are you 18 years old or older?
- Do you have advanced or spread neuroendocrine cancer?
- Did your cancer start outside of your lungs?
- Has your doctor told you that your cancer cannot be removed by surgery?
- Has a test shown that your cancer has the DLL3 marker?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you take part, you will be randomly assigned to one of two groups: either you'll receive the new drug obrixtamig plus standard chemotherapy, or you'll receive standard chemotherapy alone. You won't be able to choose which group you are in, and neither will your doctor. Both are given as infusions into a vein.
You will have regular hospital visits for your treatments and check-ups. These visits will include blood tests, physical examinations, and scans to monitor your health and how the treatment is affecting your cancer. Throughout the study, the medical team will keep a close eye on any side effects you might experience. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but it will involve ongoing assessments and potentially follow-up after treatment.
Potential risks and benefits
Locations (14)
- —Portugal
- —Spain
- —Poland
- —Sweden
- —Italy
- —Czechia
- —France
- —Netherlands
- —Finland
- —Denmark
- —Austria
- —Germany
+2 more sites — see the official record for the full list.
Common questions
What is neuroendocrine carcinoma?
It's a type of cancer that starts in special cells called neuroendocrine cells, which are found throughout the body. This study focuses on cancers that didn't start in the lungs.
What does 'advanced or metastatic' mean?
It means the cancer has either grown quite a bit in its original area or has spread to other parts of your body. 'Unresectable' means it can't be removed with surgery.
What is DLL3?
DLL3 is a specific marker that can be found on some cancer cells. For this study, your cancer needs to have this marker to be eligible.
What is 'randomised controlled trial'?
It means participants are randomly assigned to different treatment groups, like flipping a coin. This helps make sure the study results are fair and reliable.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, which means both you and your doctor will know which treatment you are receiving.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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