A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

To join this study, you must have advanced non-small cell lung cancer that has spread to other parts of the body, and your cancer must have a specific genetic change called an MTAP deletion. This will be checked by tests on your cancer cells. You must not have had any other treatment for your advanced lung cancer already, unless it was one cycle needed very quickly before joining.

Your general health needs to be good enough to take part, specifically, you should be able to carry out most daily activities without too much difficulty. The doctors will also need to be able to measure your cancer to see how it responds to treatment. You cannot have brain tumors that are causing symptoms or certain other cancer mutations for which there are already standard treatments available.

Also, you need to be able to swallow pills whole, as the study drug is taken by mouth. The study is open to patients aged 18 and over, of any gender. The study team will review all specific criteria to confirm if this study is suitable for you.

If you join this study, you will be assigned to one of two treatment groups by chance. One group will receive the new drug, Navlimetostat, along with two standard treatments: an immunotherapy called Pembrolizumab and chemotherapy. The other group will receive a dummy pill (placebo) instead of Navlimetostat, but will still receive Pembrolizumab and chemotherapy. You won't know which group you are in, and neither will your doctor.

Participation will involve regular visits to the hospital for your treatments, which will be given in cycles. You will have various tests, including blood tests, scans (like CT scans), and physical exams, to monitor your health and how the treatment is working. You'll take the study medication as prescribed, which includes pills and infusions. The length of the treatment will depend on how you respond and how you tolerate the medication, but typically continues as long as the treatment is beneficial. After the main treatment period, there will be follow-up visits to continue to monitor your health and the long-term effects of the treatment. The total duration of your involvement could be several months to a few years, including the follow-up period.