Debio 0123 in combination with carboplatin and etoposide in adult participants with small cell lung cancer that recurred or progressed after platinum-based therapy.
This study is for adults who have small cell lung cancer that has either come back or continued to grow after their initial chemotherapy treatment with medicines like carboplatin. The research team wants to see if adding a new drug, called Debio 0123, to the existing treatment of carboplatin and etoposide (another chemotherapy drug) can help. This is a very early-stage study (Phase 1), which means researchers are mainly checking if the new combination treatment is safe and what dose works best. They will also look at how the body handles the medicine. The aim is to find better ways to treat this type of lung cancer when standard treatments haven't worked as hoped.
At a glance
What is this study about?
This study is focused on a specific type of lung cancer called small cell lung cancer. This cancer is often aggressive and can come back or get worse even after initial treatment. For people whose cancer has returned or progressed after their first round of chemotherapy (usually involving a platinum-based drug like carboplatin), doctors are always looking for new and more effective treatments.
This research is testing a new drug called Debio 0123. It's not being used on its own, but in combination with two existing chemotherapy drugs: carboplatin and etoposide. You might have heard of these before, as they are commonly used in cancer treatment. By combining Debio 0123 with these established treatments, researchers hope to improve how well the chemotherapy works against the cancer.
Because this is a very early-stage study (a Phase 1 trial), the main goal is to check the safety of this new drug combination. Researchers will closely watch for any side effects and work out the best dose of Debio 0123 to use. They will also learn how the body takes in, processes, and gets rid of the new drug. Don't worry, even at this early stage, researchers will also be looking to see if the new combination shows any signs of helping to shrink the cancer or stop its growth. This is an important step in developing new medicines.
Key takeaways
- This study is for adults with small cell lung cancer that has returned or worsened after initial treatment.
- It tests a new drug (Debio 0123) combined with two standard chemotherapy drugs.
- It's a Phase 1 study, focused on safety and finding the best dose of the new combination.
- Participants will receive the active study treatment.
- Potential benefits include access to a new treatment; risks include potential side effects.
Who may be eligible?
This study is open to adults who are 18 years old or older. Both men and women can take part.
You would be considered for this study if you have small cell lung cancer, and your cancer has either come back or continued to grow after you've already had your first course of chemotherapy treatment with a 'platinum-based' drug (like carboplatin or cisplatin).
There might be other health requirements or previous treatments that could affect whether you can join, which the study team will discuss with you in detail. It's really important for your safety and the accuracy of the study that all participants meet specific health criteria.
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 small cell lung cancer?
- Has your small cell lung cancer come back or gotten worse after your first chemotherapy treatment?
- Was your first chemotherapy treatment a 'platinum-based' drug (like carboplatin)?
- Are you able to commit to regular hospital visits for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you will receive the new experimental drug Debio 0123 along with standard chemotherapy drugs, carboplatin and etoposide. The study team will explain how and when these medicines will be given, which is usually through infusions into a vein. You will have regular visits to the hospital or clinic to receive your treatment and for health checks. These checks will include blood tests, physical examinations, and scans to monitor your cancer and overall health. The frequency of visits will be explained by the study team, but they often start more frequently and may become less so over time. The total duration of your participation could vary, depending on how you respond to the treatment and the study plan, but some studies involve follow-up for several months or even longer after your treatment ends.
Potential risks and benefits
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Common questions
What is small cell lung cancer?
It's a fast-growing type of lung cancer that starts in the lung cells and can sometimes spread quickly to other parts of the body.
What does a 'Phase 1' study mean?
It's the first time a new treatment is tested in people. The main goals are to check if it's safe, find the right dose, and see how the body reacts to it.
What does 'recurred or progressed' mean?
It means your cancer has either come back after treatment, or it has continued to grow and spread despite previous treatments.
Will I get the new drug or a dummy pill?
In this specific study, you will receive the new drug Debio 0123 along with the standard chemotherapy drugs. There is no dummy pill (placebo) part in this trial.
What are platinum-based therapies?
These are common chemotherapy drugs like carboplatin or cisplatin, often used as initial treatment for small cell lung cancer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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