An open label study followed by a randomised, double-blind, placebo-controlled, parallel group and an extension study to investigate the safety and efficacy of GB1211 (a galectin-3 inhibitor) in combination with atezolizumab in patients with Non-Small Cell Lung Cancer (NSCLC).
This research study is investigating a new treatment approach for people with non-small cell lung cancer. It combines an experimental drug called GB1211, which is a 'galectin-3 inhibitor', with an approved cancer drug called atezolizumab (also known as Tecentriq). The main goals are to understand how safe this new combination is and how effectively it can help control the cancer, such as shrinking tumours or preventing their growth. Various parts of the study will help researchers find the best dose of GB1211 and check for any side effects. Participants will be closely monitored, and some may receive a placebo alongside atezolizumab, while others get the active GB1211. This helps scientists compare the new treatment's effects clearly.
At a glance
What is this study about?
This study is designed for individuals living with non-small cell lung cancer and is exploring a new combination treatment. It involves two medicines: GB1211, which is an investigational drug that works by blocking something called galectin-3, and atezolizumab (known as Tecentriq), which is an approved cancer treatment. Scientists believe that combining these two drugs might offer a more effective way to fight lung cancer.
The study has different stages, often called 'phases'. Initially, researchers are carefully looking at the safety of GB1211 when given with atezolizumab. They want to find the right dose that has good effects with manageable side effects. Once a safe dose is established, they will compare this new combination directly against atezolizumab given with a dummy pill (placebo). This helps them understand if adding GB1211 genuinely improves treatment outcomes, such as how much tumours shrink or if the cancer stops growing.
The main aim is to see if this new combination improves how long patients' cancer is controlled and if tumours respond well to the treatment. Researchers will also be tracking any side effects carefully. This type of study is crucial for discovering new and potentially better ways to treat serious conditions like lung cancer.
Key takeaways
- This study evaluates a new drug (GB1211) combined with an approved treatment (atezolizumab) for lung cancer.
- It aims to find a safe dose and see how well this combination works.
- Participation involves receiving medication, regular check-ups, blood tests, and scans.
- Some participants will receive a placebo to help compare the new treatment's effectiveness.
- Your health will be closely monitored throughout the study.
- You can withdraw from the study at any time without affecting your medical care.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. The study is open to both men and women.
There might be other specific health requirements or conditions that would mean you can or cannot take part. These details are important to ensure the study is safe for you and that the results are clear. Your doctor will be able to discuss these with you.
It's important to remember that joining a clinical study is a big decision, and it’s always best to talk it through with your own doctor. They can help you understand if this particular study is a good fit for your health situation.
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 non-small cell lung cancer?
- Are you able to attend regular hospital appointments and tests?
- Are you currently receiving treatment or considering treatment for lung cancer?
What does participation involve?
If you join this study, you'll be monitored very closely by a medical team. You'll receive either the study drug GB1211 combined with atezolizumab, or a placebo (a dummy pill with no active drug) along with atezolizumab. The atezolizumab is given as an infusion, typically into a vein, and the GB1211 (or placebo) is likely given as capsules.
Throughout the study, you'll have regular hospital visits for health check-ups, blood tests, and scans (like X-rays or CT scans) to see how your body is responding to the treatment and how your cancer is behaving. These visits help the doctors track any side effects and see if the treatment is working. The total duration of your participation could vary, but follow-up is an important part of understanding the long-term effects.
Potential risks and benefits
Locations (2)
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What is non-small cell lung cancer (NSCLC)?
NSCLC is a common type of lung cancer. This study is looking for new ways to treat it.
What is GB1211?
GB1211 is a new experimental drug that aims to block a protein called galectin-3, which might help fight cancer.
What is atezolizumab (Tecentriq)?
Atezolizumab is an existing approved cancer medicine that helps your body’s immune system fight cancer cells.
What does 'placebo-controlled' mean?
It means some people will get the active study drug, and others will get an inactive dummy pill (placebo) alongside their usual treatment to compare effects clearly.
Will I know if I'm getting the new drug or the placebo?
No, in a 'double-blind' study, neither you nor your study doctors will know who is getting the active drug or the placebo. This helps prevent bias.
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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