A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

To join this study, you would generally need to have been diagnosed with early-stage non-small cell lung cancer (adenocarcinoma type) that has been completely removed by surgery. You also need to be feeling well with good overall health after your surgery, with no other major health issues that could make the treatment unsafe. There's a specific requirement: either a blood test must show certain 'ctDNA-positive' markers, or your tumour must have had certain features that suggest a higher risk of the cancer returning, such as invasion into nearby tissues or specific cell characteristics.

On the other hand, you wouldn't be able to join if you have certain changes in your cancer (like specific EGFR or ALK mutations) or if you've had a history of serious lung problems like inflammation (pneumonitis) that needed steroids. Other reasons you might not be suitable include having another cancer diagnosis in the last three years (with some exceptions), uncontrolled health problems like severe heart or bleeding conditions, or certain active infections like tuberculosis or uncontrolled hepatitis/HIV. The doctors will do many checks to make sure this study is right and safe for you.

If you join this study, you'll be randomly assigned to receive either one of the new drug combinations (Dato-DXd with rilvegostomig, or rilvegostomig on its own) or one of the standard treatments for your type of cancer. This is like flipping a coin, so neither you nor your doctor can choose which group you're in. This helps ensure fair results when comparing treatments. You will receive your assigned medication over a period of time, which your study doctor will explain fully.

Throughout the study, you'll have regular visits to the hospital for checks, tests, and to receive your treatment. These visits will involve blood tests, scans, and discussions about how you're feeling and any side effects you might be experiencing. The study team will monitor your health very closely. After your main treatment period, you'll continue to have follow-up appointments to track your long-term health and check on the cancer. The total duration of your participation, including follow-up, will be clearly explained by the study team.