DAREON®-Lung-1: A Phase III multi-center, open-label, randomised trial of intravenous obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide as first-line treatment in patients with extensive-stage small cell lung cancer.
This study is for people with extensive small cell lung cancer. It’s comparing a new drug called obrixtamig, given with the standard treatment (atezolizumab, carboplatin, and etoposide), against the standard treatment on its own. The main goal is to find out if adding obrixtamig helps people live longer. Researchers will also check if it slows down cancer growth, improves symptoms like breathlessness, chest pain, and cough, and if it's safe. This is a Phase III study, meaning it's a large trial to confirm if the new treatment is better than existing ones.
At a glance
What is this study about?
This research study, called DAREON®-Lung-1, is investigating a new treatment option for a type of lung cancer known as extensive small cell lung cancer. In this study, doctors are looking at whether adding a new drug, called obrixtamig, to the standard treatment helps patients more than the standard treatment by itself.
Extensive small cell lung cancer means the cancer has spread quite a bit. The standard treatment often includes a combination of medicines like atezolizumab, carboplatin, and etoposide. This study is designed to see if adding obrixtamig can improve how long people live with this condition and if it helps them feel better overall. It's a large-scale study, meaning many people will take part, to get clear answers.
The main thing the doctors want to learn is if people who receive the new drug alongside standard treatment live longer. They will also be closely monitoring other things like how well the treatment stops the cancer from growing, if it helps with common symptoms such as feeling breathless, chest pain, or a cough, and what side effects people might experience. Finding out if a new treatment is effective and safe is a very important part of developing better care for patients.
Key takeaways
- This study evaluates a new drug for extensive small cell lung cancer.
- It compares a new combination therapy with standard treatment.
- The main goal is to see if the new treatment helps people live longer.
- Patient health and quality of life, like breathing and pain, will be monitored.
- Participation involves regular hospital visits for treatment and check-ups.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. The study is specifically for people who have been diagnosed with extensive small cell lung cancer.
Beyond your age and cancer diagnosis, doctors will check other aspects of your health to make sure this study is right for you and that you can safely take the study medicines. They will review your medical history and test results to confirm you meet all necessary criteria for participating.
It's important to have a chat with your doctor to see if this study could be an option for you, as they will be able to explain all the specific requirements in detail.
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 extensive small cell lung cancer?
- Are you able to attend regular hospital appointments?
- Are you willing to potentially receive either the new drug or just the standard treatment?
- Are you generally well enough to receive chemotherapy and other study drugs?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to one of two groups. One group will receive the new drug (obrixtamig) along with the standard treatment. The other group will receive the standard treatment only. Neither you nor your doctor will get to choose which group you are in; this is done by chance, like flipping a coin.
The study involves regular visits to the hospital or clinic for treatment, check-ups, and tests. These tests might include blood samples, scans, and physical examinations to see how you are responding to the treatment and to monitor for any side effects. You will receive intravenous (IV) medications, which means they are given directly into a vein.
The research team will closely monitor your health throughout the study. The total length of your participation will depend on how you respond to the treatment and the study plan, but there will also be follow-up appointments after your main treatment period ends.
Potential risks and benefits
Locations (20)
- —UnverifiedCzechia
- —UnverifiedSweden
- —UnverifiedPoland
- —UnverifiedNetherlands
- —UnverifiedGreece
- —UnverifiedLatvia
- —UnverifiedFinland
- —UnverifiedNorway
- —UnverifiedBelgium
- —UnverifiedAustria
- —UnverifiedPortugal
- —UnverifiedRomania
Common questions
What is extensive small cell lung cancer?
It's a type of lung cancer that has spread beyond the main area in the chest to other parts of the body.
What is a Phase III study?
It's a large study that compares a new treatment with existing treatments to see if it's better and confirm its safety.
Will I definitely get the new drug?
No, you will be randomly assigned to either receive the new drug plus standard treatment, or just the standard treatment. It's like drawing lots.
How will doctors know if the treatment is working?
They will use scans, blood tests, and check your symptoms regularly to see how the cancer is responding and how you are feeling.
Can I stop participating in the study if I want to?
Yes, you can leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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