A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
This study is for adults who have had surgery for non-small cell lung cancer but still have some cancer cells left, even if they can't be seen easily. Doctors want to see if adding a new medicine called sacituzumab tirumotecan to an existing medicine, pembrolizumab, can stop the cancer from returning for longer. This is being compared to receiving only pembrolizumab after surgery. The main goal is to find out if the combination treatment is better at keeping participants free from cancer for a longer period. This research is important because it could lead to better ways to prevent lung cancer from coming back after an operation.
At a glance
What is this study about?
This research study is about finding better ways to treat a type of lung cancer called non-small cell lung cancer (NSCLC) after surgery. Sometimes, after an operation to remove the cancer, not all the cancer cells are gone, even if they're too small to see. This means there's a chance the cancer could come back. This study is for people in this exact situation.
Researchers are testing a new approach that combines two medicines: sacituzumab tirumotecan and pembrolizumab. Pembrolizumab is a medicine often used in cancer treatment that helps your own immune system fight the cancer. Sacituzumab tirumotecan is a newer experimental medicine. The study wants to see if giving both these medicines together after surgery is more effective at preventing the cancer from returning compared to just giving pembrolizumab alone.
The main aim is to discover if the combined treatment can help people stay cancer-free for a longer time after their surgery. This kind of study helps doctors understand if new treatments are safer and work better than the standard ones, potentially leading to improved care for people with lung cancer.
Key takeaways
- Targets non-small cell lung cancer (NSCLC) after surgery.
- Tests a new combination of sacituzumab tirumotecan and pembrolizumab.
- Aims to prevent cancer from returning after an operation.
- Compares the new combination to pembrolizumab alone.
- Focuses on patients who didn't have a 'complete response' to surgery.
Who may be eligible?
To join this study, you would need to be an adult, 18 years or older, diagnosed with non-small cell lung cancer. Your cancer must have been at a specific stage (Stage II, IIIA, or IIIB with lymph node involvement) and considered suitable for surgery by your doctor. Importantly, you would have already had surgery for your lung cancer, and doctors would have confirmed that some cancer cells remained after the operation, meaning you didn't have a "complete response".
Other important points include that your specific type of lung cancer shouldn't require certain targeted therapies (like those for EGFR or ALK gene changes) as the main treatment. You must also be well enough to receive certain chemotherapy drugs and pembrolizumab before your surgery, and any side effects from previous treatments need to have mostly cleared up. Your doctors would also need to confirm that there's no visible cancer remaining after your surgery based on scans.
Finally, there are some health conditions that might prevent you from joining, such as uncontrolled HIV or certain types of hepatitis, unless these conditions are well managed with treatment. The study team will review all your medical information carefully to see if this study is the right fit for you.
- Are you 18 years or older?
- Do you have non-small cell lung cancer that has been removed by surgery?
- Was it confirmed that some cancer cells remained after your surgery?
- Are you able to receive certain chemotherapy and pembrolizumab before surgery?
- Have any side effects from previous treatments mostly cleared?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
The detailed steps for participating in this study would be explained fully by the study team if you are eligible. Generally, once you are identified as potentially suitable after your lung cancer surgery, you would undergo several tests and scans to confirm your eligibility. If you meet all the requirements, you would then be assigned to receive either the combination of sacituzumab tirumotecan and pembrolizumab, or pembrolizumab alone.
You would receive these treatments over a period, likely through injections or infusions, and have regular check-ups, blood tests, and scans to monitor your health and how the treatment is working. There would also be follow-up appointments after your treatment period ends to continue checking on your health and cancer status. The total duration of the study, including treatment and follow-up, would be clearly explained by the researchers.
Potential risks and benefits
Locations (264)
- UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)Little Rock, United States· Recruiting
- Highlands Oncology Group-Research Department ( Site 0062)Springdale, United States· Recruiting
- Beverly Hills Cancer Center ( Site 0070)Beverly Hills, United States· Recruiting
- The Angeles Clinic and Research Institute ( Site 0040)Los Angeles, United States· Recruiting
- The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)Los Angeles, United States· Recruiting
- UCLA Clinical & Translational Research Center (CTRC) ( Site 0033)Los Angeles, United States· Recruiting
- Hoag Memorial Hospital Presbyterian ( Site 0096)Newport Beach, United States· Recruiting
- St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 4002)Orange, United States· Recruiting
- San Francisco Oncology Associates ( Site 0066)San Francisco, United States· Recruiting
- Stamford Hospital ( Site 0083)Stamford, United States· Recruiting
- Mayo Clinic in Florida ( Site 0014)Jacksonville, United States· Recruiting
- Mount Sinai Cancer Center ( Site 0038)Miami Beach, United States· Recruiting
+252 more sites — see the official record for the full list.
Common questions
What is non-small cell lung cancer (NSCLC)?
It's the most common type of lung cancer. This study focuses on specific stages of this cancer that have been surgically removed.
What does 'pathological complete response' mean?
It means that after surgery, when doctors look at the removed tissue under a microscope, they can't find any remaining cancer cells. This study is for people where some cancer cells were still found.
What are pembrolizumab and sacituzumab tirumotecan?
Pembrolizumab is a medicine that helps your body's immune system fight cancer. Sacituzumab tirumotecan is an experimental medicine being tested to see if it works well with pembrolizumab.
Are there other treatment options available for my condition?
Yes, your doctor can discuss all standard care options for your specific type and stage of lung cancer outside of this clinical trial.
What if I change my mind after joining the study?
You can leave the study at any time. Your decision will not affect your ongoing 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?
Discussion
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