ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%
Doctors are running a study called ‘ROSETTA Lung-202’ to test a new medicine named Pumitamig for a kind of advanced lung cancer. This particular lung cancer has a specific marker, PD-L1, at 50% or higher. They are comparing Pumitamig against Pembrolizumab, which is a common treatment for this type of cancer. The main goal is to find out if Pumitamig is better at stopping the cancer from growing or helps people live longer than Pembrolizumab. They will also look at how well the new medicine shrinks the cancer and check for any side effects, making sure it's safe and tolerable for patients. The study involves adults aged 18 and over, both men and women.
At a glance
What is this study about?
This study, called ROSETTA Lung-202, is designed to find better ways to treat a specific type of advanced lung cancer known as non-small cell lung cancer. This is a common form of lung cancer. It's particularly for patients whose cancer has spread or is advanced, and has a specific characteristic called 'PD-L1 positive' (meaning a lab test showed this feature is 50% or higher).
The researchers are testing a new medicine called Pumitamig. They want to see if Pumitamig can be more effective than Pembrolizumab, which is a standard treatment doctors already use. They will be looking at two main things: whether Pumitamig can prevent the cancer from growing or spreading for a longer time, and if it helps people live longer overall.
They will also be checking other important things, like how much the tumours shrink (known as 'overall response') and how safe the new medicine is. This means they will carefully watch for any side effects and how well people tolerate the treatment. This type of study, a Phase 3 trial, is usually the final step before a new medicine might be approved for wider use, if it proves to be safe and effective.
Key takeaways
- This study compares a new lung cancer drug (Pumitamig) with a standard one (Pembrolizumab).
- It's for people with advanced non-small cell lung cancer and high PD-L1 levels.
- The main aim is to see if the new drug can stop cancer growth for longer or help people live longer.
- Both treatment groups are monitored closely for effectiveness and side effects.
- Participation involves regular clinic visits and tests, with an unknown treatment assignment.
Who may be eligible?
To be able to join this study, you need to have a specific type of lung cancer called non-small cell lung cancer. Your cancer must be advanced, meaning it has spread beyond the original site or is locally advanced. Also, a special test on your cancer cells must show that you have high levels (50% or more) of a marker called PD-L1.
You must be at least 18 years old to take part in the study. There is no upper age limit. Both men and women are welcome to participate. The study team will review other health information to make sure it's safe for you to join.
- Do I have non-small cell lung cancer?
- Has my cancer spread or is it considered locally advanced?
- Have my test results shown PD-L1 levels of 50% or higher?
- Am I 18 years old or older?
- Am I willing to attend regular hospital appointments and scans?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would receive either the new medicine, Pumitamig, or the standard treatment, Pembrolizumab. Neither you nor your doctor would know which one you are receiving – this is called a 'double-blind' study. Both medicines will likely be given through a drip into your arm (intravenously).
You would have regular visits to the clinic for treatments, check-ups, and tests like scans to see how the cancer is responding. These scans will help doctors measure if the cancer is growing, shrinking, or staying the same. They will also do blood tests and ask you questions about how you are feeling to monitor your health and any side effects. The total duration of your participation would depend on how your cancer responds to the treatment and your overall health, but you would be monitored closely throughout.
Potential risks and benefits
Locations (16)
- —Portugal
- —Norway
- —Sweden
- —Bulgaria
- —France
- —Belgium
- —Austria
- —Germany
- —Finland
- —Poland
- —Romania
- —Netherlands
+4 more sites — see the official record for the full list.
Common questions
What is non-small cell lung cancer?
It's the most common type of lung cancer. This study focuses on an advanced form of it.
What is PD-L1 50%?
It's a specific marker found on some cancer cells. Having 50% or more means your cancer has high levels of this marker, which can help doctors choose treatments.
What does 'double-blind' mean?
It means neither you nor your study doctor will know if you are receiving the new medicine (Pumitamig) or the standard treatment (Pembrolizumab). This helps make the study results fair and unbiased.
What is a Phase 3 study?
This is often the final stage of testing a new medicine. It means the medicine has already shown some promise in earlier studies, and now needs to be compared to existing treatments on a larger number of people.
Can I leave the study if I change my mind?
Yes, absolutely. You can withdraw from the study at any point, and your decision will not affect your ongoing medical care.
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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