A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab plus Chemotherapy versus Placebo plus Chemotherapy in Subjects with Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression FORTITUDE-101)
This study, called FORTITUDE-101, is exploring a new treatment for people with advanced stomach or the beginning of food pipe cancer that has not been treated before. This type of cancer has a specific feature called 'FGFR2b overexpression'. The study will compare a new drug, bemarituzumab, given alongside standard chemotherapy, against chemotherapy given with a dummy drug (placebo). The main goal is to find out if adding bemarituzumab helps people live longer. Researchers will also look at how effective the treatment is, common side effects, and how it affects a person's quality of life. Participants will be randomly assigned to receive either the new drug or the placebo, ensuring a fair comparison.
At a glance
What is this study about?
This research study, known as FORTITUDE-101, is looking into a new way to treat advanced stomach (gastric) cancer or cancer where the food pipe joins the stomach (gastroesophageal junction cancer). This study is for people whose cancer hasn't been treated yet and has a specific characteristic called 'FGFR2b overexpression.' This means the cancer cells have a lot of a certain protein on their surface, which the new drug, bemarituzumab, is designed to target.
At the moment, standard treatment usually involves chemotherapy. This study wants to see if adding bemarituzumab to this standard chemotherapy works better than just chemotherapy alone. To do this, some patients will receive bemarituzumab plus chemotherapy, while others will receive a 'dummy' drug (a placebo) plus chemotherapy. The main thing the researchers want to find out is whether patients who receive bemarituzumab live longer. They will also look at other important things, like how well the treatment shrinks the cancer, what side effects people experience, and how the treatment affects their daily life and general well-being.
By comparing these two groups of patients, the doctors hope to understand if bemarituzumab could be a valuable new treatment option for this specific type of advanced stomach or gullet cancer. The study is designed to be very thorough, helping to ensure any new findings are reliable and accurate, ultimately aiming to improve care for patients.
Key takeaways
- Tests a new drug (bemarituzumab) for advanced stomach/gullet cancer.
- Specifically for cancer with 'FGFR2b overexpression' that hasn't been treated before.
- Compares bemarituzumab plus chemotherapy to chemotherapy with a placebo.
- Aims to see if the new drug helps people live longer and improves quality of life.
- Participation involves regular hospital visits, treatments, and health checks.
Who may be eligible?
This study is for adults aged 18 years and older. Both men and women can take part. To be considered, you must have advanced stomach cancer or cancer where your food pipe meets your stomach. This means the cancer has spread or cannot be removed by surgery.
Crucially, your cancer must also have a specific feature called 'FGFR2b overexpression.' This would have been found through tests on your cancer cells. Also, you must not have received any treatment for this advanced cancer before.
There will be other medical checks and criteria to ensure the study is safe and appropriate for you, and your doctors will discuss these in detail. Your overall health and other medical conditions will be important in determining if this study is right for you.
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 stomach or where your food pipe meets your stomach cancer?
- Has your cancer been tested and found to have 'FGFR2b overexpression'?
- Have you not received any treatment for this advanced cancer yet?
What does participation involve?
If you join this study, you will be randomly assigned to one of two groups. One group will receive the new drug (bemarituzumab) along with standard chemotherapy, and the other group will receive a dummy drug (placebo) with standard chemotherapy. You, your doctor, and the study staff will not know which treatment you are receiving, which helps ensure the study results are fair.
Participation will involve regular hospital visits for your treatment, which will be given through a drip (intravenous infusion). These visits will also include various tests, such as blood tests, scans (like CT scans) to check how the cancer is responding, and physical examinations. You'll also be asked to complete questionnaires about your symptoms and how you're feeling, which helps researchers understand your quality of life.
The duration of your participation will depend on how you respond to the treatment and your health, but it will continue for as long as the treatment is benefiting you and you are tolerating it well. After stopping the study treatment, there will be follow-up appointments to monitor your health and long-term well-being.
Potential risks and benefits
Locations (18)
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- —UnverifiedBelgium
- —UnverifiedIreland
- —UnverifiedItaly
Common questions
What is 'FGFR2b overexpression'?
It's a specific feature on your cancer cells, meaning they have a lot of a certain protein. The new drug is designed to target this protein.
Will I definitely get the new drug?
No, you will be randomly assigned to either receive the new drug or a dummy drug (placebo), both given with standard chemotherapy.
What is a 'placebo'?
A placebo is a 'dummy' drug that looks like the real treatment but doesn't contain any active medicine. It helps compare the new drug fairly.
How long will I be in the study?
Your participation will continue as long as the treatment is helping you and you are tolerating it well, followed by a monitoring period.
Can I stop participating at any time?
Yes, you can choose to leave the study at any point, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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