Open-label, Phase 2 study of tusamitamab ravtansine (SAR408701) combined with pembrolizumab and tusamitamab ravtansine (SAR408701) combined with pembrolizumab and platinum-based chemotherapy with or without pemetrexed in patients with CEACAM5-positive expression advanced/metastatic nonsquamous non-small-cell lung cancer (NSQ NSCLC)
This research is looking into new ways to treat a specific kind of advanced non-small cell lung cancer that has spread. The study is called an 'open-label, Phase 2' trial, which means everyone knows what treatment they're getting, and it's an early-stage study to see if the treatments are safe and work well. We're testing a new drug called tusamitamab ravtansine, both on its own and combined with pembrolizumab (also known as Keytruda) and standard chemotherapy drugs. The main goals are to find out how safe these combinations are, how they affect the cancer, and if they can shrink tumours. This study is for adult patients whose lung cancer has a particular marker called CEACAM5.
At a glance
What is this study about?
This study is designed for people with a type of advanced lung cancer called non-small cell lung cancer (NSCLC) that is 'non-squamous' and has spread to other parts of the body (metastatic). The doctors running this study are particularly interested in patients whose cancer cells have a specific marker on their surface called CEACAM5. This is important because the new experimental drug, tusamitamab ravtansine, is designed to target cells that have this marker.
The main idea behind this research is to see if combining this new drug with existing cancer treatments can be more effective. The study will look at different combinations: tusamitamab ravtansine combined with pembrolizumab (a common immunotherapy drug known as Keytruda), and also tusamitamab ravtansine combined with pembrolizumab and chemotherapy (which might include drugs like cisplatin, carboplatin, or pemetrexed).
This kind of study (Phase 2) is a very important step. It helps doctors work out the best doses of the new drugs, understand how safe they are, and see if they can help shrink cancer or stop it from growing. By combining these treatments, researchers hope to find a better way to fight this specific type of lung cancer for patients who have limited options.
Key takeaways
- This study is for advanced, non-squamous non-small cell lung cancer.
- It focuses on cancer that has a specific marker called CEACAM5.
- The study tests a new drug combined with existing cancer treatments.
- It's a Phase 2 trial, looking at safety and how well the treatments work.
- Participation involves regular clinic visits, tests, and medication.
Who may be eligible?
To join this study, you must be 18 years old or older. Both men and women can take part.
You would need to have advanced non-small cell lung cancer that is 'non-squamous' and has spread to other parts of your body. An important requirement is that your cancer cells must show a specific 'marker' called CEACAM5. Your doctor will be able to check for this marker with specific tests.
There might be other health requirements that your doctor will discuss with you to make sure the study treatment is suitable and safe 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 non-small cell lung cancer that is 'non-squamous'?
- Has your cancer spread to other parts of your body?
- Has your doctor confirmed that your cancer cells have the CEACAM5 marker?
- Are you able to attend regular clinic appointments for treatment and tests?
What does participation involve?
If you decide to join this study, you will receive one of the experimental treatment combinations. This could involve an injection or infusion (a drip into your vein) of the study drugs. The specific drugs and how often you receive them will depend on which treatment group you are in, and your study doctor will explain this in detail.
Throughout the study, you will have regular visits to the clinic for medical check-ups, blood tests, and scans. These tests are important to monitor how you are responding to the treatment, to check for any side effects, and to make sure the treatment is safe for you. The study will continue for a period, and you will have follow-up appointments even after your main treatment phase to monitor your long-term health.
The total duration of your participation in the study, including the treatment and follow-up, will be fully explained by the study team. You will stop treatment if your cancer gets worse, or if intolerable side effects occur.
Potential risks and benefits
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Common questions
What is CEACAM5?
CEACAM5 is a specific protein marker found on the surface of some cancer cells. This study is for people whose lung cancer has this marker.
What does 'open-label' mean?
It means both you and your study doctor will know exactly which medicines you are receiving during the trial.
What is a Phase 2 study?
Phase 2 studies are early-stage trials that aim to see if a new treatment is safe and effective in a larger group of people, after earlier smaller safety studies.
What are the treatments being tested?
The study tests a new drug called tusamitamab ravtansine, either alone or with existing drugs like pembrolizumab (Keytruda) and chemotherapy medicines (cisplatin, carboplatin, pemetrexed).
What is the main goal of this study?
The main goal is to find out how safe these new treatment combinations are and whether they can help shrink tumours or control the cancer in patients with CEACAM5-positive lung cancer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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