A Phase III, Randomized, Double-Blind Study of Tiragolumab Plus Atezolizumab Compared with Placebo Plus Atezolizumab in Participants with Completely Resected Stage IIB, IIIA, or Select IIIB, PD-L1 Positive, Non-Small Cell Lung Cancer who have received Adjuvant Platinum-Based Chemotherapy
This research study is for people who have been diagnosed with a specific type of lung cancer called Non-Small Cell Lung Cancer. This is for those whose cancer has been completely removed by surgery and who have already had standard chemotherapy treatment. The study aims to find out if adding a new medicine called Tiragolumab to another drug, Atezolizumab, can be more effective than Atezolizumab alone in stopping the cancer from returning. Researchers are particularly interested in a specific feature of the cancer cells, known as PD-L1 positive, which helps them understand how the treatments might work. The main goal is to carefully monitor how patients react to these treatments and check for any side effects.
At a glance
What is this study about?
This clinical trial is designed to investigate a new treatment approach for a specific group of people who have had successful surgery for Non-Small Cell Lung Cancer. After surgery, some people receive chemotherapy to reduce the chance of the cancer coming back. This study is for individuals who have completed this chemotherapy. The researchers want to see if adding an investigational drug called Tiragolumab to another treatment called Atezolizumab can further improve outcomes. Atezolizumab is a type of immunotherapy that helps your body's own immune system fight cancer.
Non-Small Cell Lung Cancer is the most common type of lung cancer. Even after surgery and chemotherapy, there's a risk that the cancer might return. This trial focuses on trying to lower that risk. The study carefully compares the new combination of drugs against Atezolizumab on its own. This is a very important step to understand if new treatments are safe and work better than existing ones.
The study is particularly interested in a specific characteristic of the cancer cells, called PD-L1 positive. This helps doctors understand which treatments might be most effective for different patients. By taking part, you would be helping medical science learn more about how to manage lung cancer and potentially improve future treatments for many others.
Key takeaways
- Tests a new combination of drugs for lung cancer after surgery and chemotherapy.
- Aims to prevent cancer from returning.
- For adults with a specific type of Non-Small Cell Lung Cancer (PD-L1 positive).
- Compares a new combination to a standard treatment.
- Participation involves regular check-ups and monitoring.
- Your health and safety are the top priority throughout the study.
Who may be eligible?
This study is looking for adults aged 18 or older. It is for people who have been diagnosed with a specific type of lung cancer called Non-Small Cell Lung Cancer.
To be considered, your cancer must have been completely removed by surgery, and you must have already finished a course of chemotherapy treatment normally given after surgery. Also, your cancer cells need to show a particular feature called PD-L1 positive, which the doctors will check through tests.
Both men and women can take part in this research. There might also be other health conditions or previous treatments that could affect whether you can join, which your doctor will discuss with 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?
- Have you been diagnosed with Non-Small Cell Lung Cancer?
- Has your lung cancer been completely removed by surgery?
- Have you already finished your chemotherapy treatment after surgery?
- Have your cancer cells been tested and found to be 'PD-L1 positive'?
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would have medical examinations, blood tests, and scans to monitor your health and how the treatment is affecting you. You would receive either the combination of Tiragolumab and Atezolizumab or Atezolizumab on its own, given through an injection or infusion.
The study would also involve carefully tracking any side effects you might experience. After your treatment period, there would be a follow-up phase where doctors continue to monitor your health over time, even after you've stopped taking the study medication. The total length of your involvement in the study, from starting treatment to the final follow-up, would be for a significant period, but the intense treatment phase is usually shorter.
Potential risks and benefits
Locations (12)
- —UnverifiedGermany
- —UnverifiedAustria
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedRomania
- —UnverifiedSlovakia
- —UnverifiedFrance
- —UnverifiedIreland
- —UnverifiedHungary
- —UnverifiedGreece
Common questions
What is Non-Small Cell Lung Cancer?
It's the most common type of lung cancer. This study is for people whose cancer has been completely removed through surgery.
What does 'PD-L1 positive' mean?
It's a specific feature on your cancer cells that doctors look for. It helps them predict how well certain treatments, like the ones in this study, might work.
What is chemotherapy, and why did I have it?
Chemotherapy uses medicines to kill cancer cells throughout your body. After surgery, it's given to reduce the chance of any remaining cancer cells causing the cancer to come back.
Will I know which treatment I am receiving?
No, this is a 'double-blind' study. This means neither you nor your study doctor will know whether you are getting the new combination or the standard treatment. This helps ensure the study results are fair and unbiased.
What are 'adverse events'?
These are any unwanted or unexpected effects that happen during the study. The research team will carefully track and manage all of these.
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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