Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

To be considered for this study, you would need to have non-small cell lung cancer that is advanced or has spread. An important detail is that your cancer must be 'TROP2-positive,' which means your cancer cells have a specific marker that the new study drug targets. This will be checked using a sample of your tumour.

You must have already received a specific set of treatments for your advanced lung cancer. This typically means you've had platinum-based chemotherapy along with immunotherapy (like anti-PD-1 or anti-PD-L1 drugs). These treatments would have been your first or first two lines of therapy, and your cancer must have progressed after them.

It's also important that your cancer does not have certain other specific genetic changes (like in EGFR, ALK, ROS1, or others) that already have approved targeted treatments. The study is open to both men and women aged 18 and over, and a doctor would need to confirm that your cancer can be measured on scans.

If you join this study, you will be randomly assigned to receive either the new drug, Datopotamab Deruxtecan (Dato-DXd), or the standard chemotherapy, Docetaxel. The study is 'open-label,' meaning both you and your study doctor will know which treatment you are receiving. You will need to attend regular clinic visits for your treatment, which will be given as infusions (into a vein). During these visits, there will be various assessments including physical exams, blood tests, and scans (such as CT or MRI) to monitor your health and how the treatment is working. You will also be asked to provide a tumour sample. The total duration of your participation will depend on how you respond to the treatment and the study's follow-up schedule.