A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum Based Chemotherapy with Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL 1L)
This important study is for adults with advanced non-small cell lung cancer that has either stayed the same or improved after initial chemotherapy and another drug called Pembrolizumab. Researchers want to find out if adding a drug called Niraparib to Pembrolizumab works better than Pembrolizumab alone. They will be looking to see if the combination helps people live longer or stops their cancer from getting worse for longer. The study is in its final stage of testing, meaning it's comparing the new treatment against a standard one, and it involves lots of medical checks to make sure it's safe and effective. Participants will either receive the new combination or Pembrolizumab with a dummy pill, so doctors and patients won't know who is getting which treatment until the study ends.
At a glance
What is this study about?
This study, called ZEAL 1L, is all about finding better ways to treat a type of advanced lung cancer called non-small cell lung cancer (NSCLC). This is the most common type of lung cancer. For people whose cancer has responded well to their first treatment – usually a combination of chemotherapy and another drug called Pembrolizumab – doctors want to see if adding an extra medication, Niraparib, can help even more. The study is trying to confirm if this new combined treatment can keep the cancer from growing for longer or help people live longer.
Imagine you've had your first round of treatment, and it's worked well. This study is testing if giving you Niraparib alongside Pembrolizumab will be more effective than just continuing with Pembrolizumab on its own. To make sure the results are fair and accurate, some people will get Niraparib along with Pembrolizumab, while others will get a dummy pill (placebo) along with Pembrolizumab. Neither the patients nor their doctors will know who is getting which, which helps prevent any bias in the results.
The main things the researchers are looking at are how long people live (overall survival) and how long it takes before the cancer starts to grow again or gets worse (progression-free survival). They will regularly check participants' health and scan their bodies to measure the cancer. This is a "Phase 3" study, which means it's a large, in-depth study designed to show if a new treatment is truly better than existing options before it can become widely available.
Key takeaways
- Tests a new combination treatment for advanced lung cancer.
- Aims to see if the new treatment helps people live longer or stops cancer growth for longer.
- Compares Niraparib plus Pembrolizumab versus Pembrolizumab alone.
- Participants will either get the new combination or Pembrolizumab with a dummy pill (placebo).
- Close medical monitoring and regular check-ups are part of the study.
- It's a Phase 3 study, meaning it's a final stage of testing for new treatments.
Who may be eligible?
To join this study, you would generally need to be an adult, 18 years or older. It is for people who have advanced non-small cell lung cancer, specifically Stage IIIB, IIIC, or IV.
Your cancer would need to have remained stable or improved after you've completed your first full course of platinum-based chemotherapy and have also been treated with Pembrolizumab. This means your initial treatment has worked well, and the doctors are looking to build on that success.
There will be other detailed medical checks to make sure the study is safe for you and that the results will be clear. For example, doctors will check your overall health, liver and kidney function, and other specific blood tests to make sure you can safely take the study medications. If you have other serious medical conditions or have had certain treatments previously, you might not be able to join.
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 advanced non-small cell lung cancer (Stage IIIB, IIIC, or IV)?
- Has your cancer stayed stable or improved after your initial chemotherapy and Pembrolizumab treatment?
- Are you able to attend regular hospital visits and undergo medical tests?
- Are you willing to potentially receive either the active study drug or a dummy pill?
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to one of two groups. One group will receive Niraparib tablets plus Pembrolizumab infusions, and the other group will receive dummy tablets (placebo) plus Pembrolizumab infusions. You won't know which group you are in, and neither will your doctor.
Your participation will involve regular visits to the clinic for treatments, check-ups, and tests. These tests include blood samples, physical exams, and scans (like CT or MRI) to see how your cancer is responding. These checks are important for monitoring your health and the progress of the treatment. The total time you'll be involved in the study can vary, depending on how you respond to the treatment and how long you continue to benefit from it. There will also be follow-up appointments after you stop taking the study medication to monitor your long-term health. The study team will provide all the details about the schedule of visits and assessments.
Potential risks and benefits
Locations (14)
- —UnverifiedNetherlands
- —UnverifiedPoland
- —UnverifiedHungary
- —UnverifiedRomania
- —UnverifiedGermany
- —UnverifiedBulgaria
- —UnverifiedSweden
- —UnverifiedGreece
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedNorway
- —UnverifiedItaly
Common questions
What type of cancer is this study for?
This study is for advanced non-small cell lung cancer (Stage IIIB, IIIC, or IV).
What medicines are being tested?
The study is testing a combination of Niraparib and Pembrolizumab against Pembrolizumab alone, with one group receiving a dummy pill (placebo).
What does 'Phase 3' mean?
Phase 3 means this is a large, advanced study to see if the new combination treatment works better than existing options and is safe enough for wider use.
Will I know which treatment I'm getting?
No, neither you nor your doctor will know whether you are receiving Niraparib or the dummy pill, ensuring fair and unbiased results.
How long will I be in the study?
The length of your participation can vary, depending on how your cancer responds to the treatment and your overall health. There will also be follow-up after treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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