A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

To join this study, participants must be adults diagnosed with a specific kind of non-small cell lung cancer that has an EGFR gene change (either Exon 19 deletion or Exon 21 L858R mutation). Their cancer must be locally advanced or have spread to other parts of the body. They must have previously received one treatment for their lung cancer (a third-generation EGFR TKI) and the cancer must have started growing again after that treatment. We'll also need a sample of their tumour tissue, either old or new, to check these details.

There are also some things that would mean someone couldn't join. For example, if their lung cancer is a different type (like squamous cell or adenosquamous) or if they've already had more than one type of treatment for their advanced lung cancer. People with certain severe medical conditions or lung problems (like a history of interstitial lung disease that needed steroids) would also not be able to take part. The study team will check all these details carefully to make sure it's the right study for you.

If you decide to take part in this study, you'll be involved for about 69 months, which is over five and a half years. The study has two stages. In the first stage (Phase 2), some participants will receive one of two different doses of the study drug, telisotuzumab adizutecan, given directly into a vein (intravenously, or IV). In the second stage (Phase 3), participants will either receive the chosen dose of telisotuzumab adizutecan (given IV) or they will receive the standard treatment for their condition.

Throughout the study, you'll need to attend regular visits at an approved hospital or clinic. During these visits, the study team will carry out medical checks, blood tests, and ask you to complete questionnaires to see how you're feeling and how the treatment is affecting you. They'll also monitor any side effects you might experience. These frequent checks are important to understand how the new drug compares to existing treatments.