A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination with Irinotecan versus Investigator’s Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer (SCLC) Patients (LAGOON Trial)
This important study, known as the LAGOON trial, is for people with small cell lung cancer (SCLC) that has returned after initial treatment. It's a 'Phase III' study, which means it's comparing new treatments with existing ones to find out which is best. The study is testing a new drug called lurbinectedin, either on its own or teamed up with another drug called irinotecan. These are being compared against standard care drugs like topotecan or irinotecan, chosen by your doctor. The main goal is to see if any of the new approaches help people live longer, and also how well they stop the cancer from growing and how they affect your quality of life.
At a glance
What is this study about?
This clinical trial, called the LAGOON study, is designed for people who have been diagnosed with small cell lung cancer (SCLC) and whose cancer has returned after they've already had treatment. This type of cancer can sometimes be aggressive, and researchers are always looking for better ways to manage it, especially when it comes back.
The main aim of this study is to compare different treatment approaches. Some patients will receive a drug called lurbinectedin, either by itself or combined with another drug called irinotecan. Other patients will receive one of the standard treatments currently used for relapsed SCLC, which could be topotecan or irinotecan, chosen by their doctor. By comparing these different options, the researchers hope to find out which treatment is most effective.
The most important thing the study wants to measure is how long people live (this is called 'overall survival'). But they will also look at how long people live without their cancer growing (which is called 'progression-free survival'), how many people respond to the treatment, and how safe the treatments are. They will also consider how the treatments affect patients' daily lives and well-being. This information helps doctors understand which treatment works best, has the fewest side effects, and genuinely improves patients' lives.
Key takeaways
- This study is for adults with small cell lung cancer that has returned.
- It tests a new drug, lurbinectedin, alone or with irinotecan, against standard treatments.
- The main goal is to find out if these new treatments help people live longer.
- Participation involves regular clinic visits, tests, and medical assessments.
- You won't choose your treatment group; it's decided by chance.
- You can stop participating in the study at any time.
Who may be eligible?
To join this study, you generally need to be an adult, aged 18 or older. It is open to both men and women.
The study is specifically for people who have been diagnosed with small cell lung cancer (SCLC) and whose cancer has come back after they've had their first course of treatment. There will be other specific medical details that your doctor will check against the study's rules to make sure you are a good fit and that it's safe for you to take part.
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 small cell lung cancer?
- Has your small cell lung cancer returned after previous treatment?
- Are you able to attend regular clinic appointments and tests?
What does participation involve?
If you decide to join this study, you would be assigned to one of the treatment groups by chance, like flipping a coin. You wouldn't get to choose which group you are in. You would receive regular doses of the study medication, either lurbinectedin, lurbinectedin with irinotecan, or one of the standard treatments (topotecan or irinotecan).
Your involvement would include regular visits to the clinic for medical check-ups, blood tests, scans, and to talk about how you are feeling and any side effects you might be experiencing. These visits help the study team monitor your health and how the treatment is working. You might also be asked to complete questionnaires about your quality of life. The total length of your participation would depend on how your treatment is going, and you would have follow-up appointments even after you stop taking the study medication to see how you are doing in the long term.
Potential risks and benefits
Locations (11)
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- —UnverifiedItaly
- —UnverifiedBulgaria
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedRomania
- —UnverifiedHungary
Common questions
What is 'small cell lung cancer'?
Small cell lung cancer is a type of lung cancer that tends to grow and spread quite quickly. Doctors are always looking for better treatments for it.
What does 'relapsed' mean?
Relapsed means the cancer has come back after you've had treatment for it before.
What is a 'Phase III' study?
This is a big study that compares a new treatment with an existing standard treatment to see if the new one is better or has fewer side effects. It's often the last step before a new drug might become widely available.
Will I get to choose which treatment I receive?
No, in this study, the treatment you receive is chosen by chance to make sure the comparison between treatments is fair. This means you will be randomly assigned to a group.
What are 'patient-reported outcomes'?
These are questionnaires or discussions where you share how you are feeling, your symptoms, and your quality of life during the study. Your answers are very important for understanding how treatments affect patients day-to-day.
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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