LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

This study is testing a new experimental cancer vaccine called BNT116 for people with non-small cell lung cancer. The researchers want to see how safe this vaccine is and if it works well when given alone or combined with other standard cancer treatments.

This study is for adults diagnosed with non-small cell lung cancer at various stages, ranging from early stages that can be surgically removed to more advanced, metastatic stages. You must be able to tolerate immunotherapy and meet specific health criteria, such as not having certain active autoimmune conditions or untreated brain metastases.

Participants will receive the experimental vaccine alone or in combination with other approved or investigational treatments. You will be closely monitored by a medical team to ensure the treatments are safe and to see how your body responds to them.

The study is currently recruiting patients at specific medical centers in Lexington and Louisville, Kentucky, as well as in Baltimore, Maryland. As this is an early-stage study, researchers are carefully collecting information to confirm the best and safest doses.