Open-label non-randomized multicentric phase 2 study evaluating the combination of bemarituzumab + FLOT chemotherapy in perioperative setting for resectable stage cT2-T4a or N+ gastric and GEJ adenocarcinoma overexpressing FGFR2b (BEMAFLOT)
This study is testing a new way to treat certain stomach and food pipe cancers. It combines a newer drug, bemarituzumab, with common chemotherapy medicines. The aim is to give this treatment before surgery to see how much it shrinks the cancer. This is important because shrinking the tumour before surgery can sometimes lead to better results. Researchers will closely watch for any side effects and how patients are doing generally. The study focuses on cancers that have a specific marker called FGFR2b, which helps doctors understand if this new drug might work for them. It's a Phase 2 study, meaning it's still in the early stages of testing this specific combination.
At a glance
What is this study about?
This clinical study is designed to investigate a new treatment approach for certain types of stomach cancer and cancer in the area where the food pipe joins the stomach. These are called gastric and gastro-oesophageal junction adenocarcinomas. The new approach involves combining a drug called bemarituzumab with standard chemotherapy medicines a few weeks before surgery. The main goal is to see how effectively this combination treatment shrinks the tumour before it is surgically removed. Doctors believe that shrinking the tumour significantly before an operation could make the surgery more successful.
Specifically, this study is looking at cancers that have a particular feature called "FGFR2b overexpression." This means the cancer cells have a lot of a certain protein on their surface. Bemarituzumab is designed to target this specific protein, aiming to fight the cancer more effectively when this protein is present. By combining it with chemotherapy, the hope is to create a powerful treatment that improves outcomes for patients with this specific type of cancer.
This is a Phase 2 study, which means it's an early-stage trial. Researchers are trying to find out if this treatment is safe and effective in shrinking tumours. They will closely monitor participants for any side effects, assess their quality of life, and track their health over several years to understand the full impact of the treatment. The findings from this study will help determine if this combination treatment should be tested in larger studies in the future.
Key takeaways
- It's for specific stomach and food pipe cancers.
- Combines a new drug (bemarituzumab) with standard chemotherapy.
- Treatment is given before surgery to shrink tumours.
- Only for cancers with a specific marker (FGFR2b overexpression).
- Close monitoring for side effects and long-term health.
Who may be eligible?
To join this study, people generally need to be 18 years old or older. The study is open to both men and women.
You would be considered for this study if you have stomach cancer or cancer where your food pipe meets your stomach. Your cancer needs to be at a stage where surgery is planned and where the cancer is either in the stomach wall (classified as cT2-T4a) or has spread to nearby lymph nodes (classified as N+).
Additionally, a very important requirement is that your cancer cells must show a specific feature called 'FGFR2b overexpression'. This will be checked by doctors before you can join the study, as the main drug being tested targets this specific feature.
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 stomach cancer or cancer where your food pipe joins your stomach?
- Is your cancer at a stage where surgery is planned and involves some tumour growth or spread to nearby lymph nodes?
- Has your doctor confirmed that your cancer shows 'FGFR2b overexpression'?
What does participation involve?
If you decide to take part in this study, you would receive the study treatments before your planned surgery. The treatments involve several medications given by injection or infusion (into a vein).
Throughout the study, you would have regular visits to the hospital for checks. These visits will involve blood tests, physical examinations, and scans to see how the treatment is affecting your cancer and your general health. Researchers will also ask you to complete questionnaires about your quality of life and your nutrition to understand how you are feeling.
After your surgery, you will have a follow-up period that could last up to five years. During this time, you will continue to have regular check-ups, usually every three months for the first two years, then every six months until the five-year mark. This is to monitor your health and check for any signs of the cancer returning.
Potential risks and benefits
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Common questions
What kind of cancer is this study for?
This study is for certain types of stomach cancer and cancer where the food pipe joins the stomach (gastro-oesophageal junction adenocarcinoma).
What is 'FGFR2b overexpression'?
It means your cancer cells have a lot of a specific protein called FGFR2b. The new drug in the study is designed to target this protein.
Will I still have surgery if I join this study?
Yes, the treatments in this study are given before your planned surgery to try and shrink the tumour.
What are the treatments in this study?
You would receive a newer drug called bemarituzumab along with several standard chemotherapy medicines such as fluorouracil and oxaliplatin.
How long will I be involved in the study?
The treatment period is before surgery, but doctors will follow your health for up to five years after treatment and surgery to see how you are doing long-term.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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