A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
This study is looking for a better way to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that's considered 'high-risk' and has been fully removed by surgery. Even after surgery, this type of cancer sometimes comes back. Researchers are testing two potential new medicines, Intismeran (V940) and Pembrolizumab (MK-3475A), to see if they can help prevent the cancer from returning. They want to find out if these new treatments, either alone or together, are more effective than a dummy drug (placebo) in keeping people cancer-free after their operation. The study focuses on people aged 18 and over, of all genders.
At a glance
What is this study about?
When someone has non-small cell lung cancer (NSCLC), especially in its early stages, surgery is often the main treatment to remove the cancer. However, for some people, even after a successful operation, there's a risk the cancer might come back. This study is designed for those individuals whose early-stage NSCLC is considered 'high-risk' for returning.
The researchers are investigating new medicines that could help reduce this risk. The study is testing two main treatments: one is called Intismeran (V940) and the other is a combination of Pembrolizumab with berahyaluronidase alfa (MK-3475A). Intismeran is like a special training programme for your immune system, teaching it to recognise and fight your specific cancer cells. Pembrolizumab is an immunotherapy that works by boosting your body's natural defences to find and destroy cancer cells. These medicines are given after surgery to try and catch any remaining cancer cells.
Participants will be divided into different groups. Some will receive Intismeran on its own, others will get Intismeran combined with Pembrolizumab, and a third group will receive a placebo – which looks like the active drug but contains no medicine. This allows researchers to compare the new treatments against what usually happens without them. The main goal is to see if taking these study medicines after surgery helps people stay cancer-free for longer. It's hoped that these new approaches could offer better outcomes for patients with high-risk early-stage lung cancer.
Key takeaways
- This study is for adults with early-stage lung cancer (NSCLC) that's been removed by surgery but has a high chance of returning.
- It's testing new medicines (Intismeran and Pembrolizumab) to see if they can prevent the cancer from coming back.
- Participants will receive either one of the new medicines, a combination of them, or a placebo (dummy drug).
- The main goal is to find out if these new treatments help people stay cancer-free for longer.
- Taking part means regular hospital visits for checks and receiving study medication, possibly by injection.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is for adults, aged 18 and older, who have been diagnosed with early-stage non-small cell lung cancer (NSCLC). Your cancer must have been fully removed by surgery, and your doctors will have identified that it has certain features that put you at a higher risk of the cancer returning. They might look at things like the size of the tumour or if it has spread to certain areas close by.
To be considered, you should not have had any other cancer treatments, like chemotherapy or radiotherapy, for your lung cancer before joining the study, apart from your surgery. You'll also need to provide a tissue sample from your recent surgery and a blood sample for the researchers to check specific details about your cancer and health.
There are also some conditions that would mean you couldn't join. For example, if you have other types of lung cancer (like small cell lung cancer), or if you've had significant heart problems in the past year. Also, if you have certain uncontrolled infections like HIV or hepatitis, you might not be able to take part. The study team will review all your medical information carefully to see if this study is right 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.
- Are you 18 years old or older?
- Have you had surgery to remove early-stage non-small cell lung cancer?
- Has your doctor told you your cancer is considered 'high-risk' for returning?
- Have you not had other treatments (like chemo or radiation) for this lung cancer apart from surgery?
- Do you have a tissue sample from your surgery and a blood sample available for the study?
What does participation involve?
If you decide to take part in this study, you'll be randomly assigned to one of the treatment groups, like flipping a coin. This means you might receive Intismeran alone, Intismeran plus Pembrolizumab, or a placebo (a dummy drug). You won't know which treatment you're getting, nor will your study doctor, which helps keep the results fair.
The study involves regular visits to the clinic for assessments, which will include physical examinations, blood tests, and scans (like CT scans) to check how you're doing and if the treatment is working. The study medicines will be given over a period of time, and you'll have follow-up appointments even after you stop taking the study drugs, to monitor your health in the long term. Your study doctor and nurse will explain the full schedule of visits and tests, as well as how and when you'll receive the medication, including injections.
Potential risks and benefits
Locations (68)
- Smilow Cancer Center at Yale-New Haven ( Site 3253)Verified postcodeNew Haven, United States· Recruiting
- Billings Clinic ( Site 3255)Verified postcodeBillings, United States· Recruiting
- NHO Revive Research Institute, LLC ( Site 3218)Verified postcodeLincoln, United States· Recruiting
- Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)Verified postcodeReno, United States· Recruiting
- White Plains Hospital ( Site 3213)Verified postcodeWhite Plains, United States· Recruiting
- Charles George VA Medical Center ( Site 3233)Verified postcodeAsheville, United States· Recruiting
- WakeMed Raleigh Campus ( Site 3214)Verified postcodeRaleigh, United States· Recruiting
- Altru Health System ( Site 3254)Verified postcodeGrand Forks, United States· Recruiting
- Avera Cancer Institute ( Site 3209)Verified postcodeSioux Falls, United States· Recruiting
- The University of Tennessee Medical Center ( Site 3223)Verified postcodeKnoxville, United States· Recruiting
- West Virginia University ( Site 3237)Verified postcodeMorgantown, United States· Recruiting
- Royal North Shore Hospital ( Site 0502)Verified postcodeSt Leonards, Australia· Recruiting
Common questions
What does 'high-risk Stage I NSCLC' mean?
It means you have early-stage lung cancer that's been removed by surgery, but your doctors have found certain features that suggest it has a higher chance of coming back.
What is the difference between Intismeran and Pembrolizumab?
Intismeran helps your immune system learn to attack your specific cancer. Pembrolizumab is an immunotherapy that generally boosts your immune system to fight cancer.
Will I know which treatment I'm getting?
No, you won't know if you're getting an active study medicine or a placebo (dummy drug). This helps make sure the study results are fair and accurate.
How long will I be involved in the study?
You will receive treatment for a period, and then continue to have regular check-ups for some time afterwards to monitor your health. The study team will explain the full expected duration.
Can I stop participating in the study at any time?
Yes, you are always free to leave the study at any point, for any reason, without it affecting your standard medical care.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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