A PHASE 1/2 STUDY OF REGN5093 IN PATIENTS WITH MET-ALTERED ADVANCED NON-SMALL CELL LUNG CANCER
This study is researching a new medicine, REGN5093, for advanced non-small cell lung cancer in patients whose cancer has a specific 'MET-altered' gene change. This is typically for people whose cancer has unfortunately spread. The study has two main parts. The first part is to find the safest dose of REGN5093 by carefully monitoring side effects. The second part aims to understand how well the medicine shrinks the cancer or stops it from growing. Researchers will also look at how long the benefits last and how patients' general health is affected. This is a vital step in developing new treatments for this challenging type of lung cancer.
At a glance
What is this study about?
This research study is focused on a specific type of advanced lung cancer called non-small cell lung cancer (NSCLC). This trial is for patients whose cancer has spread and has a particular genetic change, or 'alteration', known as 'MET-altered'. This means that the cancer cells have a change in their DNA that might make them grow and spread more easily. Researchers are hoping that the new medicine, REGN5093, could target this specific change.
The study has two main stages, called Phase 1 and Phase 2. Phase 1 is like an early testing stage where the main goal is to find the safest dose of REGN5093. The research team will give different doses to small groups of patients and watch very carefully for any side effects or problems. This helps them understand how the body handles the medicine and what dose is best to move forward with.
Once a safe dose is identified, the study moves into Phase 2. In this stage, more patients will receive the medicine at the dose found to be safe. The main goal of Phase 2 is to see how effective REGN5093 is at treating the cancer. This includes checking if the cancer shrinks or stops growing, and how long these effects last. Throughout both phases, the research team will continuously monitor patients' health, looking for any side effects and checking general well-being. This careful approach helps ensure that any new medicine is not only effective but also as safe as possible for patients.
Key takeaways
- This study is for advanced, MET-altered non-small cell lung cancer.
- It's testing a new medicine called REGN5093.
- The first stage focuses on finding a safe dose, the second on how well it works.
- Participation involves regular hospital visits for assessments.
- There are potential benefits and risks, as with any new treatment.
- You can stop participating at any time.
Who may be eligible?
To be able to join this study, there are certain requirements that you need to meet. First and foremost, you must have advanced non-small cell lung cancer that has been identified by tests as 'MET-altered'. This means your cancer has a specific genetic change.
Your doctor will also check if you are healthy enough to take part and if the treatment might be suitable for you. They will look at your overall health, your other medical conditions, and any medicines you are currently taking.
This study is open to both men and women, aged 18 years and older. There is no upper age limit, so older adults are welcome to be considered for participation if they meet the other health criteria.
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.
- Do you have advanced non-small cell lung cancer?
- Has your cancer been tested and found to be 'MET-altered'?
- Are you 18 years old or older?
- Are you generally well enough to take part in a clinical trial, as decided by your doctor?
- Are you able to attend regular hospital appointments?
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic. Initially, these visits might be quite frequent to closely monitor how you're responding to the medicine and if you're experiencing any side effects. You would receive the study medicine, REGN5093, as directed by the study doctors.
During your visits, you would likely have various assessments. These might include blood tests, scans (like CT scans or X-rays) to check the size of your cancer, and physical examinations. You'll also be asked questions about how you're feeling and any symptoms you might have. These tests help the doctors understand how the medicine is affecting you and your cancer.
The total duration of your participation in the study would depend on how your cancer responds to the medicine and if you experience any side effects. You would continue to receive the medicine for as long as it is benefiting you and you are tolerating it well. After you stop taking the study medicine, there would likely be follow-up visits to monitor your health and gather final information about the treatment.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
What kind of cancer is this study for?
This study is for people with advanced non-small cell lung cancer that has a specific genetic change called 'MET-altered'.
What is REGN5093?
REGN5093 is a new medicine being tested. It's hoped that it will help treat the 'MET-altered' type of lung cancer.
Will I definitely get the new medicine?
Yes, if you join this study, everyone will receive the new medicine, REGN5093. This isn't a study where some people get a dummy treatment.
What are 'phases' in a clinical trial?
Phases are stages of research. Phase 1 finds a safe dose, and Phase 2 checks how well the treatment works while still watching for side effects.
Can I leave the study if I want to?
Yes, absolutely. You can choose to leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.