A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
This study is investigating a new treatment approach for patients with non-small cell lung cancer that hasn't fully responded to initial treatment before surgery. We are testing a drug called intismeran autogene alongside pembrolizumab, a commonly used immunotherapy, given after surgery. The main goal is to find out if this combination can help keep people cancer-free for longer compared to those who receive pembrolizumab alone. Researchers believe that adding intismeran autogene might boost the body's immune response to better fight any remaining cancer cells. This is a Phase 3 trial, meaning it's comparing the new treatment to a standard one in a larger group of patients to ensure it's both safe and effective for people across the UK with this specific type of lung cancer.
At a glance
What is this study about?
This research is looking at a new treatment for a type of lung cancer called non-small cell lung cancer, which is the most common form. Sometimes, before surgery, patients are given treatment to shrink their tumour. This study is for people whose cancer didn't completely disappear with that initial treatment, but they still went on to have surgery. The main aim is to see if a new drug, intismeran autogene, when given with a standard immunotherapy drug called pembrolizumab, can stop the cancer from coming back after surgery.
Pembrolizumab works by helping your body's own immune system find and fight cancer cells. Researchers want to know if adding intismeran autogene to pembrolizumab can make this immune response even stronger, giving patients a better chance of staying cancer-free for longer. They will compare this combination with pembrolizumab given alone to see if there's a difference.
This is an important step in developing new ways to treat lung cancer. By understanding if this combination is more effective than current approaches, doctors can make better decisions about treatment for patients in the future. The study is organised so that some patients receive the new combination, while others receive pembrolizumab with a 'dummy' treatment (placebo), so that the effects of intismeran autogene can be clearly assessed.
Key takeaways
- New study for non-small cell lung cancer after surgery.
- Compares a new drug (intismeran autogene) with existing immunotherapy (pembrolizumab).
- Aims to see if the new combination keeps cancer from returning longer.
- Participation involves regular hospital visits, treatments, and monitoring.
- You have the right to withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you must have been diagnosed with non-small cell lung cancer that doctors consider suitable for surgery, specifically in stages II, IIIA, or IIIB. Importantly, you would have already received treatment to shrink your cancer before surgery, and your doctors would have confirmed that not all of the cancer was cleared by this initial treatment. You also need to be generally well and able to carry out your normal daily activities without too much difficulty.
There are some specific requirements regarding your cancer type; for example, it cannot be a different type of lung cancer called small cell lung cancer, and your tumour shouldn't have certain genetic changes that would mean other treatments are more suitable. If you have conditions like HIV or hepatitis, you might still be able to join if these are well-managed with your current medication.
However, you cannot take part if you've had previous special immunotherapy drugs (like anti-PD-1 or anti-PD-L1 treatments) or certain other types of lung cancer. The study is for adults aged 18 and older, and welcomes both men and women.
- Have you had surgery for non-small cell lung cancer?
- Did some cancer remain after your treatment before surgery?
- Are you generally well and able to manage daily activities?
- Are you aged 18 or older?
- Have you not had certain specific immunotherapy drugs in the past?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you take part in this study, you will receive either the new combination treatment (intismeran autogene and pembrolizumab) or pembrolizumab with a placebo (a dummy treatment). The specific medication you receive will be decided by chance, like flipping a coin. You'll have regular hospital visits for treatments, blood tests, and scans to monitor your health and how you're responding. The total duration of your treatment and follow-up will be explained by the study team, but generally involves receiving treatment for a period and then being monitored for a longer time to see if the cancer returns. This allows the researchers to gather comprehensive data.
Potential risks and benefits
Locations (232)
- Banner MD Anderson Cancer Center ( Site 0181)Gilbert, United States· Recruiting
- The University of Arizona Cancer Center - North Campus ( Site 0163)Tucson, United States· Recruiting
- Providence St. Jude Medical Center ( Site 0106)Fullerton, United States· Recruiting
- VA Long Beach Healthcare System ( Site 0199)Long Beach, United States· Recruiting
- USC Norris Comprehensive Cancer Center ( Site 0205)Los Angeles, United States· Recruiting
- UCSF Medical Center at Mission Bay ( Site 0178)San Francisco, United States· Recruiting
- University of Colorado Anschutz Medical Campus ( Site 0151)Aurora, United States· Recruiting
- UCHealth Memorial Hospital Central ( Site 0125)Colorado Springs, United States· Recruiting
- Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)Greeley, United States· Recruiting
- Centura Health - St. Anthony North Health Campus ( Site 0189)Westminster, United States· Recruiting
- Yale University School of Medicine ( Site 0201)New Haven, United States· Recruiting
- Eastern CT Hematology & Oncology Associates ( Site 0202)Norwich, United States· Recruiting
+220 more sites — see the official record for the full list.
Common questions
What is non-small cell lung cancer?
It's the most common type of lung cancer. This study is for people who have had surgery for it.
What is pembrolizumab?
It's a type of immunotherapy that helps your body's immune system fight cancer cells.
What is intismeran autogene?
It's a new experimental drug being tested to see if it can improve the effects of pembrolizumab in preventing cancer recurrence.
Why is 'placebo' mentioned?
A placebo is a 'dummy' treatment. It helps researchers compare the effects of the active drug accurately.
Can I stop participating if I want to?
Yes, you can leave the study at any time, and it won't affect your regular 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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