A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).
This research study, called TeLuRide-008, is exploring a new way to treat advanced non-small cell lung cancer. It involves giving patients a combination of treatments: the existing immunotherapy drug called pembrolizumab, standard chemotherapy, and a new study drug called EIK1001. Some patients will receive a dummy drug (placebo) instead of EIK1001 to compare its effects. The main goals are to find out if this new combination helps patients live longer and if it slows down the cancer's growth. Researchers will also look at how well the new treatment shrinks tumours and what side effects it might cause. The study is global, meaning people from different countries are taking part.
At a glance
What is this study about?
This study is for people with advanced non-small cell lung cancer, specifically stage 4. This means the cancer has spread from where it started to other parts of the body. Lung cancer can be challenging to treat, and doctors are always looking for better options to help patients. This research aims to see if combining existing treatments with a new drug could be more effective.
You might be offered a combination of two known treatments: pembrolizumab, which is an immunotherapy that helps your body's immune system fight cancer, and chemotherapy, which uses strong drugs to kill cancer cells. On top of these, you'll also receive a new study drug called EIK1001 or a 'dummy' drug (placebo). The placebo looks exactly like EIK1001 but contains no active medicine. This allows researchers to fairly compare the effects of EIK1001.
The main things the researchers want to find out are whether this treatment combination helps people live longer and if it stops or slows down the cancer from growing or spreading. They will also be closely monitoring how your cancer responds to the treatment, for example, if tumours shrink, and keeping a careful eye on any side effects you might experience. This is a "Phase 2/3" study, which means it's testing the new drug's safety and how well it works on a larger group of people after initial safety tests.
Key takeaways
- This study is testing a new drug, EIK1001, for stage 4 non-small cell lung cancer.
- It combines EIK1001 with existing treatments: pembrolizumab and chemotherapy.
- The aim is to see if the new combination slows cancer growth and helps patients live longer.
- Some patients will receive a placebo (dummy drug) instead of EIK1001.
- All participants will receive close medical monitoring and care.
Who may be eligible?
To be considered for this study, you must have been diagnosed with stage 4 non-small cell lung cancer. This means your cancer has spread beyond your lungs.
Participants must be at least 18 years old. There's no upper age limit, so older adults can also take part. The study is open to both men and women.
While these are the basic requirements, there will be other medical checks and criteria that a study doctor will discuss with you to make sure the study is a good fit and safe for you.
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.
- Have you been diagnosed with Stage 4 Non-Small Cell Lung Cancer?
- Are you 18 years old or older?
- Are you able to travel to the study clinic for regular appointments?
- Are you willing to consider receiving a placebo (dummy drug) as part of the study?
What does participation involve?
If you decide to take part in this study, you'll be assigned by chance (like flipping a coin) to one of the treatment groups: either pembrolizumab, chemotherapy, and EIK1001, or pembrolizumab, chemotherapy, and a placebo (dummy drug similar to EIK1001). You won't know which group you're in, nor will your study doctor, to keep the results fair.
The treatment will involve regular visits to the clinic for infusions of the medications. You'll have various tests and scans, such as blood tests and imaging (like CT scans), at specific times throughout the study to monitor your health, how the treatment is affecting your cancer, and to check for any side effects. These assessments help the doctors understand if the treatment is working and if it's safe.
The total length of your participation in the study will depend on how your cancer responds to the treatment and your overall health. You will continue to receive treatment for as long as it's helping and you're not experiencing severe side effects. After your treatment period, there will be follow-up appointments to continue monitoring your health and wellbeing.
Potential risks and benefits
Locations (6)
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedRomania
- —UnverifiedGreece
- —UnverifiedItaly
Common questions
What is Non-Small Cell Lung Cancer?
It's the most common type of lung cancer, and 'stage 4' means it has spread to other parts of your body.
What does 'double-blind' mean?
It means neither you nor your doctor will know if you're getting the active study drug (EIK1001) or a dummy drug (placebo). This helps make the study fair.
What is pembrolizumab?
It's an immunotherapy drug already used for lung cancer. It helps your body's immune system fight off cancer cells.
Will I have to pay to be in the study?
No, your participation in the study, including the medication and study-related tests, will be provided at no cost to you.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, without it affecting your future medical care.
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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