Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)

To be considered for this study, you would need to have non-small cell lung cancer that is locally advanced (Stage IIIB/C and can't be removed with surgery) or has spread to other parts of your body. An important factor is that your cancer cells must show a specific marker called PD-L1, which will be checked from a recent tumor sample.

Also, you must have already received certain previous treatments for your lung cancer. This includes at least one course of immunotherapy (a PD-1/PD-L1 inhibitor) and a chemotherapy containing a drug called platinum. These two treatments could have been given at the same time or one after the other. Your overall health and ability to perform daily activities would also be assessed, usually needing to be good enough for you to participate safely.

There are also some reasons why you might not be able to join. For instance, if your tumor has certain specific gene changes (like in EGFR, ALK, RET, or ROS1), you might not be eligible. However, if your cancer has KRAS or BRAF mutations, you might still be able to join if suitable targeted treatments aren't available to you. The study team would carefully check all your medical information to see if this study is suitable for you.

If you join this study, you'll first have a screening period that could last up to 28 days (and an optional 3-month pre-screening). During this time, you'll have various tests to make sure the study is right for you. If you qualify, you will then be randomly assigned to one of two treatment groups.

One group will receive a combination of acasunlimab (100 milligrams) and pembrolizumab (400 milligrams) as an intravenous drip once every six weeks. The other group will receive docetaxel (75 milligrams per square meter of body surface) as an intravenous drip once every three weeks. The treatment part of the study can last for up to two years.

Throughout the treatment period, you'll have regular hospital visits for your medications, check-ups, and to monitor your health and any side effects. Researchers will also ask you questions about your quality of life. After your treatment ends, there will be a 90-day safety follow-up period, followed by long-term follow-up visits or calls to monitor your health for up to five years in total from the start of the study.