Phase III Study of AK112 for NSCLC Patients

To join this study, you would generally need to be between 18 and 75 years old, although in North America and Europe, there's no upper age limit. Your lung cancer must be a specific type called non-squamous non-small cell lung cancer, and it needs to be locally advanced or have spread (metastatic). Importantly, your cancer must have a specific genetic change (called an EGFR mutation), and it must have progressed or worsened after you've already received a type of targeted therapy for this mutation.

You'll also need to be well enough to take part, meaning you should have a good level of physical activity and an expected survival of at least three months. Doctors will check your general health and organ function through tests to make sure it's safe for you to participate.

If you join this study, you'll be randomly assigned to one of two groups, like flipping a coin. You'll either receive the new drug AK112 plus the standard chemotherapy, or a dummy injection (placebo) plus the standard chemotherapy. Neither you nor your doctor will know which group you are in – this helps ensure the study results are fair.

The initial treatment will involve injections given every three weeks for up to four cycles. After these first cycles, you will continue with maintenance treatment, which means you'll receive either AK112 or the placebo plus one of the chemotherapy drugs (pemetrexed) every three weeks for up to two years, or until your cancer progresses or you need to stop for other reasons. Throughout the study, you'll have regular hospital visits for infusions, check-ups, and tests to monitor your health and how the treatment is working. We don't have exact details on the number of visits, but it will be regular over the treatment period.