Phase 2, Single-arm, Open-label Study of DS1062a in Advanced or Metastatic Non-small Cell Lung Cancer with Actionable Genomic Alterations and Progressed on or After Applicable Targeted Therapy and Platinumbased Chemotherapy (TROPION-Lung05)
This study is testing a new treatment called Datopotamab deruxtecan for a type of lung cancer known as non-small cell lung cancer (NSCLC). This is for people whose cancer is advanced or has spread, has certain genetic changes, and has either got worse or stayed the same after standard targeted therapy and chemotherapy. The main goal is to find out how many people respond well to the treatment, meaning their tumours shrink or disappear. Researchers will also look at how long these responses last, how the treatment affects the size of existing tumours, and if it helps control the disease or extends life. Safety is also a key focus, monitoring any side effects people might experience.
At a glance
What is this study about?
Imagine your body like a house, and sometimes, certain parts, like a room, can start to grow out of control – this is a bit like cancer. In this study, doctors are focusing on a specific type of lung cancer called non-small cell lung cancer (NSCLC) that's considered 'advanced' or has spread to other parts of the body. This particular study is for people whose cancer has specific changes in its genetic code that might make it respond differently to treatments. Importantly, these patients have already received standard treatments like targeted therapy and chemotherapy, and their cancer has either grown or hasn't improved.
The main idea behind this study is to see how well a new drug, Datopotamab deruxtecan, works. Think of this drug as a special tool designed to target those specific changes in the cancer cells. The team wants to find out if this new drug can shrink the tumours or even make them disappear in some patients. They'll also be tracking how long any positive effects last and how people generally feel while taking the treatment.
This is a 'Phase 2' study, which means it's an important step to see if the new drug is effective and safe enough to potentially become a new treatment option in the future. The information gathered from this study will help doctors understand more about this drug and how it could help people with this type of lung cancer.
Key takeaways
- Looks at a new drug, Datopotamab deruxtecan, for advanced non-small cell lung cancer.
- For patients whose cancer has specific genetic changes and hasn't responded to previous treatments.
- Aims to see if the new drug can shrink tumours.
- Researchers will also monitor how long the treatment works and any side effects.
- This is a Phase 2 study, an important step in researching new treatments.
Who may be eligible?
To be considered for this study, you generally need to be an adult, aged 18 or over. The study is open to both men and women.
Key to eligibility is your diagnosis: you must have advanced non-small cell lung cancer that has spread to other parts of your body, and your cancer needs to have specific genetic changes that doctors can identify. It's also important that your cancer has either got worse or stayed the same after you've already had treatments like targeted therapy and chemotherapy.
There might be other health requirements or previous treatment details that your doctor will check against specific study rules to make sure the study is a good fit for you.
- Are you 18 years old or older?
- Have you been diagnosed with advanced non-small cell lung cancer that has spread?
- Does your cancer have specific genetic changes (your doctor would know this)?
- Have you already received targeted therapy and chemotherapy for your cancer?
- Has your cancer either grown or not improved after these previous treatments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll be given the study drug, Datopotamab deruxtecan, as part of your treatment. You will have regular visits to the hospital or clinic so the doctors can monitor your health and how the treatment is working. These visits will involve various tests, such as blood and urine tests, heart checks like ECGs and echocardiograms (which look at your heart using sound waves), and scans to see if your tumours are shrinking. The medical team will also keep a close eye on any side effects you might experience. The total duration of your participation will depend on how you respond to the treatment and the study's design for follow-up.
Potential risks and benefits
Locations (3)
- —Netherlands
- —France
- —Spain
Common questions
What kind of lung cancer is this study for?
It's for a type called non-small cell lung cancer (NSCLC) that is advanced or has spread, and has specific genetic changes.
Why is this drug being tested?
It's a new potential treatment being studied for people whose cancer hasn't responded well to standard targeted therapy and chemotherapy.
What does 'tumour response' mean?
It means the doctors want to see if your tumours shrink or disappear after receiving the new drug.
Will I have regular check-ups?
Yes, you will have regular visits to the clinic for tests and to monitor your health and any side effects.
Can I stop participating if I want to?
Yes, you can choose to stop participating in the study at any time, for any reason.
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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