Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

To join this study, you would typically need to be an adult, at least 18 years old.

Your non-small cell lung cancer (NSCLC) needs to be advanced, specifically Stage IIIB, IIIC, or IV, meaning it's either spread quite a bit locally or to other parts of the body. Importantly, your cancer shouldn't have certain common genetic changes that doctors usually look for and treat with other specific medicines. You also need to be generally well enough to take part, meaning you can handle most daily activities without too much difficulty, and your blood tests and organ function should be within healthy ranges. The doctors will also need a sample of your tumour tissue to check if you're suitable.

There are also some reasons why you might not be able to join. For example, if you have a mix of non-small cell and small cell lung cancer, or certain other types of cancer, or if you have severe issues with your brain, spine, or lungs which are not tumour-related. Also, if you have certain infections or eye problems, or if you're still recovering from previous treatments, you might not be able to participate.

If you decide to take part in this study, you'll be randomly assigned to one of two treatment groups, like flipping a coin. You won't get to choose which treatment you receive. One group will get the new combination of Dato-DXd, durvalumab, and carboplatin, while the other group will receive the standard treatment of pembrolizumab and chemotherapy (either cisplatin or carboplatin with pemetrexed or paclitaxel, depending on your cancer type).

Throughout the study, you'll have regular visits to the hospital for treatment, check-ups, blood tests, and scans to see how you're responding. Doctors will closely monitor your health and any side effects you might experience. The exact number of visits and tests will be detailed by the study team. You'll continue treatment as long as it's helping and you're not experiencing severe side effects. After your treatment period, there will be follow-up appointments to track your long-term health. The total duration of your participation could vary, as it depends on how you respond to treatment and for how long you're followed up.