A multicenter phase II study of neoadjuvant sacituzumab govitecan plus zimberelimab followed by adjuvant zimberelimab with or without sacituzumab govitecan in patients with resectable non-small cell lung cancer (NeoTRACE) [without IMPD-Q]
This research study, called NeoTRACE, is for people in the UK who have non-small cell lung cancer that doctors believe can be fully removed by surgery. The study is trying out new drug treatments, sacituzumab govitecan (also known as Trodelvy) and zimberelimab, to see how well they work together. Patients will receive these medicines before their surgery, and then zimberelimab, with or without sacituzumab govitecan, afterwards. The main goal is to find out if these treatments can get rid of all the cancer cells in the tumour that is removed during surgery. The study also looks at how safe the treatments are, how they affect quality of life, and how long people stay free from cancer.
At a glance
What is this study about?
This study, named NeoTRACE, is looking into new ways to treat non-small cell lung cancer that can be removed by an operation. Non-small cell lung cancer is the most common type of lung cancer. Sometimes, even after surgery, there's a chance the cancer could come back. This study aims to find better ways to reduce that risk.
The researchers are testing a combination of two drugs: sacituzumab govitecan (also known as Trodelvy) and zimberelimab. Sacituzumab govitecan is designed to deliver a cancer-fighting medicine directly to cancer cells, while zimberelimab is a type of immunotherapy that helps your own immune system fight the cancer. The idea is that using these drugs before and after surgery might make the surgery more successful and prevent the cancer from returning.
The main thing the study wants to find out is how often the combination of these new treatments can get rid of all the cancer cells in the tumour that is taken out during surgery. This is called a 'pathological complete response'. They will also be looking at how safe the treatments are, how they affect your quality of life, and if they help people stay cancer-free for longer.
Key takeaways
- It's about new drugs for a type of lung cancer that can be surgically removed.
- Drugs are given before and after surgery.
- Aims to fully remove cancer cells and prevent recurrence.
- This is a Phase II study, meaning it's exploring how well the treatments work and their safety.
- Quality of life and long-term health are also being monitored.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. The study is open to both men and women.
Crucially, you must have been diagnosed with non-small cell lung cancer that your doctors believe can be successfully removed by an operation.
There will be other detailed medical criteria that your doctor will check to make sure the study is a safe and suitable option for 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 doctor told you that your lung cancer can be removed by surgery?
- Are you able to commit to hospital visits for treatment and check-ups?
What does participation involve?
If you decide to take part, you'll first receive the study drugs, sacituzumab govitecan and zimberelimab, before your surgery. After your surgery, you will continue to receive zimberelimab, and some patients might also continue with sacituzumab govitecan. All medications will be given as an infusion, meaning it goes directly into your bloodstream.
You will have several hospital visits for treatments, check-ups, scans, and blood tests before and after your surgery. These tests are to see how the treatment is working and to monitor your health. The total time you'll be involved in the study will include the treatment period and follow-up appointments to check on your long-term health and how you're feeling.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What kind of cancer is this study for?
It's for a type of lung cancer called non-small cell lung cancer that can be treated with surgery.
What are the main treatments being tested?
Two drugs called sacituzumab govitecan (Trodelvy) and zimberelimab.
Will I have surgery if I join this study?
Yes, this study is specifically for people whose cancer can be removed by surgery. The drugs are given before and after the operation.
What is the study trying to find out?
The main goal is to see if the drugs can get rid of all the cancer cells in the tumour that is removed during surgery.
How long will I be involved in the study?
This includes the treatment period and regular follow-up appointments to check on your health over time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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