This study wants to learn how safe the study drug V940 is when given with pembrolizumab and how well this treatment works in people with non-small cell lung cancer after surgery.
People with stage II to IIIB non-small lung cancer often have surgery and standard cancer treatment. Even after surgery, the cancer may come back. This study wants to learn if adding the study drug V940 to pembrolizumab may help lower the chance of the cancer coming back. If you join this study, you will first have a screening visit to see if you can take part. Screening takes about 1 month. During this time, the study team will check your health and how you are feeling. You may have blood and urine tests, a physical exam, heart tests, and imaging scans. Everyone in the study will get pembrolizumab. Your study treatment will depend on whether you have already had surgery to remove your cancer. If you have not had surgery, you will get pembrolizumab and chemotherapy before surgery. These medicines are given through a vein in your arm and are part of your standard care for this type of lung cancer. This treatment lasts about 12 weeks, and you will have about 4 to 8 clinic visits. Your surgery will happen about 8 weeks after you finish these treatments. If you stay in the study after surgery, you will get additional treatment for about 10 months. During this time, you will get pembrolizumab through a vein in your arm every 6 weeks for 7 visits. You will also be randomly placed into one of two groups, like flipping a coin. One group will get V940, the study drug. The other group will get a placebo, which looks like the same as the study drug but has no active medicine. Neither you nor the study team will know which group you are in. V940 or the placebo will be given as a shot into your muscle every 3 weeks for 9 visits. You will stay in the study as long as you are doing well, and your cancer does not get worse. During study visits, the study team will ask about your health, review your medicines, and check your vital signs. You will give blood and urine samples. You may also fill out surveys about your symptoms, daily activities, and quality of life using a tablet. Some visits will include imaging scans to see how your cancer is responding. After you finish treatment, you will have 1 follow up visit about a month later. The study team may then call you or schedule more visits with you every 3 months for up to 12 years. You and your insurance will need to pay for your routine medical care. You will be paid up to $50 for each study visit you finish. You may also get reimbursed for travel costs.
You may be able to join this study if you are 18 or older and have Stage II, IIIA, or IIIB (N2) non-small cell lung cancer that can be removed with surgery. Your cancer must be confirmed by tissue sample, and you cannot have had treatment for this cancer before. Tests must also show that a treatment called epidermal growth factor receptor is not right for you. You may also join if you have had chemotherapy and pembrolizumab before surgery, and the cancer was not fully removed. You cannot join if you have small cell lung cancer, a mixed tumor, certain gene changes in your tumor, or if you have had immune-based cancer treatments.
Protocol Number: 24-2314
More information available at ClinicalTrials.gov: NCT06623422
Principal Investigator