A Phase III, Randomized, Open-Label Study of Pralsetinib versus Standard Of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer
This research is a 'Phase III' study, which means it’s a big step in getting a new medicine approved. It focuses on a type of advanced lung cancer called Non-Small Cell Lung Cancer, specifically when it has a genetic change called a 'RET fusion.' The study wants to find out if a new drug called Pralsetinib is more effective and safer than the usual treatments for people who are receiving their first treatment for this condition. Participants will be randomly assigned to either receive Pralsetinib or one of the standard chemotherapy treatments, which might also include other drugs like Keytruda. Doctors will carefully monitor how the cancer responds and if there are any side effects. The main goal is to see if Pralsetinib can stop the cancer from growing for longer.
At a glance
What is this study about?
This clinical trial is designed to investigate a new treatment called Pralsetinib for a specific type of advanced lung cancer. This cancer is known as Non-Small Cell Lung Cancer, and it's being studied in people whose cancer has spread (metastatic) and has a particular genetic feature called a 'RET fusion.' This genetic change means the cancer cells have a faulty gene that can make them grow and spread.
Researchers want to see if Pralsetinib is a better first treatment option compared to the standard treatments currently used. Standard treatments often include chemotherapy drugs like Carboplatin, Cisplatin, Gemcitabine, or Pemetrexed, and sometimes other drugs like Keytruda or Abraxane. By comparing these treatments, the study aims to understand if Pralsetinib can help people live longer, stop the cancer from growing for a longer period, or have fewer serious side effects.
The study is in 'Phase III,' which means it's one of the final steps before a new medicine can be approved for general use. It involves a large number of people and provides important information to doctors and medical regulators about how well and how safely a new treatment works.
Key takeaways
- This study is for advanced lung cancer with a specific genetic change (RET fusion).
- It compares a new drug, Pralsetinib, to existing standard treatments.
- The goal is to see if Pralsetinib is more effective or safer for first-time treatment.
- Participants will be closely monitored for cancer response and side effects.
- It's a 'Phase III' study, a crucial step for new drug approval.
Who may be eligible?
To be considered for this study, you need to be an adult, at least 18 years old. The study is open to both men and women. The most important requirement is that you must have been diagnosed with a specific type of lung cancer called Non-Small Cell Lung Cancer that has spread to other parts of your body (metastatic).
Crucially, your cancer must also have a particular genetic fault known as a 'RET fusion.' Doctors will check for this genetic change with a special test. This study is for people who have not yet received any treatment for their advanced lung cancer.
There will be other detailed medical criteria that your doctor will check to make sure the study is right for you and safe. These usually involve your general health, other medical conditions you might have, and your blood test results. Your doctor will discuss all these with you.
- Are you 18 years old or older?
- Do you have Non-Small Cell Lung Cancer that has spread (metastatic)?
- Has your cancer been tested and found to have a 'RET fusion' genetic change?
- Have you *not* yet started treatment for your advanced lung cancer?
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 would be randomly assigned to receive either the new drug, Pralsetinib, or one of the standard chemotherapy treatments, which might include specific medicines like Carboplatin, Gemcitabine, Pemetrexed, Cisplatin, Keytruda, or Abraxane. 'Randomly assigned' means you won't get to choose which treatment you receive, similar to flipping a coin.
Throughout the study, you would have regular hospital visits for medication, check-ups, blood tests, scans (like X-rays or CT scans), and physical exams. These assessments help doctors monitor how your cancer is responding to treatment and identify any side effects. You will be closely monitored for your health and any changes. The total duration someone participates can vary depending on how their cancer responds and how they feel, but it typically involves regular contact for many months.
Potential risks and benefits
Locations (10)
- —France
- —Netherlands
- —Belgium
- —Germany
- —Spain
- —Portugal
- —Poland
- —Norway
- —Italy
- —Ireland
Common questions
What is 'RET fusion-positive' lung cancer?
This means your lung cancer cells have a specific genetic mistake called a 'RET fusion,' which is like a faulty 'on' switch that can make the cancer grow.
What does 'metastatic' mean?
'Metastatic' means the cancer has spread from where it started in the lung to other parts of your body.
Will I know which treatment I'm getting?
Yes, in this study, it's 'open-label,' meaning both you and your doctors will know which treatment you are receiving (either Pralsetinib or standard care).
What does 'Phase III' mean for a study?
Phase III means it's a large study, usually comparing a new treatment to standard care, to confirm if it's safe and works better before it's approved for wider use.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.
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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