A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)
This study is for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced and hasn't been treated with other medicines before. The cancer also needs to have high levels of a specific protein called PD-L1. Researchers want to see if a new combination of two drugs, belrestotug and dostarlimab, is a safe and effective treatment compared to a standard drug called pembrolizumab, which is often used for this type of cancer. A 'placebo' (a dummy drug) will also be used in some parts of the study to help accurately compare the treatments. This is a Phase 3 study, meaning it's a large trial to confirm how well the new treatment works and its safety.
At a glance
What is this study about?
When someone has cancer, doctors are always looking for better ways to treat it. This particular research study is focusing on a common type of lung cancer known as non-small cell lung cancer (NSCLC). This study is for people whose lung cancer is advanced, meaning it has spread or can't be removed by surgery or strong radiation treatment, and has not been treated with any other medicines for their advanced cancer yet.
Doctors have found that some lung cancers have high levels of a protein called PD-L1. This can be important because certain medicines, like pembrolizumab, known as 'immunotherapies', specifically target this protein to help the body's own immune system fight the cancer. This study is testing if a new combination of two other treatments, belrestotug and dostarlimab, works better or is just as good, and as safe, as the standard treatment pembrolizumab.
Belrestotug and dostarlimab are also types of immunotherapy. Immunotherapy works by boosting your body's natural defences to recognise and attack cancer cells. By combining these two new drugs, researchers hope to give the immune system an even stronger push to fight the cancer. This study is very important because it could lead to new treatment options for people with this specific type of lung cancer.
Key takeaways
- This study is testing a new combination of drugs for advanced lung cancer.
- It's for people with a specific type of lung cancer with high PD-L1 levels who haven't had prior treatment for it.
- The study compares the new treatment to a standard cancer treatment.
- It's a 'Phase 3' study, which means it's a large trial to confirm treatment effectiveness and safety.
- Regular hospital visits, treatments, and tests will be part of taking part.
- You can withdraw from the study at any time.
Who may be eligible?
To be part of this study, you need to have non-small cell lung cancer that has been confirmed by lab tests. Your cancer must be advanced, meaning it has spread or cannot be removed by surgery or intense radiation. Importantly, you mustn't have received any treatment for your advanced lung cancer yet.
Also, your tumour needs to show high levels of a specific protein called PD-L1 (at least 50%). Doctors also need to be able to measure your cancer, meaning there's at least one tumour that can be tracked. Your general health and how well your body's organs are working will also be checked. Generally, participants should be able to perform daily activities with little or no difficulty.
You would not be able to join if your lung cancer has certain genetic changes that can be treated with specific targeted medicines already. If you've had major surgery or strong lung radiation recently, or if you've already had immunotherapy in the past, you also wouldn't be able to take part. People who have never smoked or who have had another invasive cancer in the last 5 years (except for very low-risk types) are also not eligible.
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 I have non-small cell lung cancer confirmed by a doctor?
- Has my lung cancer spread, or can it not be removed by surgery or strong radiation?
- Have I had any treatment for my advanced lung cancer yet? (If yes, you might not be eligible).
- Do tests show my cancer has high levels (at least 50%) of the PD-L1 protein?
- Am I generally well enough to do most daily activities?
- Have I had a conversation with my doctor to check if my cancer has certain genetic changes that would prevent me from joining?
What does participation involve?
If you decide to join this study, you will be assigned to one of two treatment groups. One group will receive the new combination of belrestotug and dostarlimab, while the other group will receive pembrolizumab (a standard treatment) along with a 'placebo' (a dummy drug). You won't know which group you are in, and neither will your doctors.
The treatments will be given as infusions (through a drip into your vein) over several months. You will need to come to the hospital or clinic regularly for these treatments and for check-ups. These check-ups will include blood tests, health assessments, and scans (like CT scans) to see how you are responding to the treatment and to keep an eye on any side effects. The exact number of visits and the total duration in the study will be explained in detail by the study team.
Potential risks and benefits
Locations (134)
- GSK Investigational SiteVerified postcodeOcala, United States
- GSK Investigational SiteVerified postcodeHonolulu, United States
- GSK Investigational SiteVerified postcodeLexington, United States
- GSK Investigational SiteVerified postcodeLexington, United States
- GSK Investigational SiteVerified postcodeAnn Arbor, United States
- GSK Investigational SiteVerified postcodeOmaha, United States
- GSK Investigational SiteVerified postcodeNashville, United States
- GSK Investigational SiteVerified postcodeFort Worth, United States
- GSK Investigational SiteVerified postcodeOlympia, United States
- GSK Investigational SiteVerified postcodeBuenos Aires, Argentina
- GSK Investigational SiteUnverifiedCipoletti Rio Negro, Argentina
- GSK Investigational SiteCity onlyCiudad Autonoma de Buenos Aire, Argentina
Common questions
What is PD-L1 high lung cancer?
It means your cancer cells have a lot of a specific protein called PD-L1. This is important because some medicines target this protein to help your immune system fight the cancer.
What is a Phase 3 study?
Phase 3 means this is a large study to confirm if a new treatment is safe and effective compared to existing treatments, and eventually decide if it can be approved for wider use.
Will I get a 'dummy drug' (placebo)?
Some people in the study will get pembrolizumab plus a placebo. The placebo helps researchers accurately compare the effects of the new treatment with the standard one.
Can I stop participating in the study at any time?
Yes, you can choose to leave the study at any point, for any reason. Your decision will not affect your future medical care.
What if my cancer has genetic changes (mutations)?
If your cancer has certain specific genetic changes that can be treated with approved targeted medicines, you would likely not be eligible for this study.
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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