“Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Pembrolizumab in Patients with Relapsed Small Cell Lung Cancer (the LUPER study).”
This research study is for people with small cell lung cancer that has returned after previous treatment. It's called the 'LUPER' study and involves two drugs: Lurbinectedin and Pembrolizumab. The study has two main parts. First, it aims to find the right and safest dose of these two drugs when given together. The doctors will carefully watch for any side effects to determine this. Second, once the best dose is found, the study will check how effective this drug combination is at shrinking or controlling the cancer. This is a "Phase I/II" study, meaning it's an early step to understand both safety and effectiveness for this new treatment approach.
At a glance
What is this study about?
This study is an early-stage clinical trial looking for a better way to treat small cell lung cancer (SCLC) that has returned after initial treatment. SCLC can be a challenging cancer, and researchers are always looking for new and more effective treatments. This particular study is investigating a combination of two medicines, Lurbinectedin and Pembrolizumab, to see if they work well together.
The study has two main goals. The first goal (Phase I) is to carefully find the safest and most effective dose of these two drugs when given in combination. Doctors will start with lower doses and slowly increase them, while closely monitoring participants for any side effects. This careful approach helps ensure that future patients receive the best possible dose. The second goal (Phase II) is to then see how well this combined treatment works to fight the cancer once the best dose is established. Researchers will measure if the tumours shrink or stop growing.
By taking part in a study like this, you would be helping doctors learn more about how to treat SCLC. This research is crucial for developing new treatments that could improve the lives of many people in the future. Remember, participating in a clinical trial is a big decision, and it's always good to discuss it thoroughly with your own doctor.
Key takeaways
- This study is for returning small cell lung cancer.
- It tests two drugs together: Lurbinectedin and Pembrolizumab.
- The first goal is to find the safest dose.
- The second goal is to see how well the combination works.
- You will have regular blood tests and scans.
- Participation is voluntary, and you can leave at any time.
Who may be eligible?
This study is designed for adults who are at least 18 years old. Both men and women are welcome to participate.
The most important health condition for this study is that you must have small cell lung cancer that has returned or progressed after you've already had some initial treatment for it.
There will be other detailed health checks to make sure this study is safe and suitable for you, including blood tests and scans, which your study doctor will explain fully.
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 or progressed after previous treatment?
- Are you able to travel to the study clinic for appointments?
What does participation involve?
If you decide to join this study, you'll receive a combination of two medications: Lurbinectedin and Pembrolizumab. These medications are given as an infusion, meaning they are delivered directly into your bloodstream, likely through a drip into a vein. You will have regular appointments at the hospital for these infusions and for various checks.
During the study, you'll have frequent visits, especially in the beginning. These visits will involve blood tests to check your general health, how your body is handling the medication, and to monitor for any side effects. You will also have regular scans, such as CT scans or MRI scans, to see how the treatment is affecting your cancer. These scans will help the doctors understand if the tumours are shrinking or staying stable. The exact number of visits and the full duration of your participation will depend on how you respond to the treatment and what your study doctor recommends, but typically, scans are done every two treatment cycles.
Potential risks and benefits
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Common questions
What is small cell lung cancer?
Small cell lung cancer is a type of lung cancer that can grow and spread quickly. This study is for people whose cancer has returned after initial treatment.
What are Lurbinectedin and Pembrolizumab?
These are two different medicines being tested together. Lurbinectedin is a cancer drug, and Pembrolizumab is an immunotherapy that works with your body's immune system to fight cancer.
What does 'Phase I/II' mean?
This means it's an early research study. Phase I focuses on finding the safest dose and understanding side effects. Phase II then checks how well the treatment works against the cancer.
Will I get a placebo (dummy drug)?
No, this study does not involve a placebo. Everyone participating will receive the active study drugs, Lurbinectedin and Pembrolizumab.
How long will I be in the study?
The length of your participation can vary. You will continue treatment as long as it is helping you and you are not experiencing severe side effects. The study team will keep you informed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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