A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations

This study is testing a new oral medication called sevabertinib to see if it works better than standard care for patients with advanced non-small cell lung cancer that has a specific HER2 gene mutation. By blocking the protein that helps these cancer cells grow, researchers hope to find a more effective way to stop the spread of the disease.

You may be eligible if you are at least 18 years old and have been diagnosed with advanced lung cancer that has a confirmed HER2 mutation. You must not have received prior drug treatments for this stage of cancer, and your doctor must confirm that you are healthy enough for the standard treatment options included in the study.

Participants will be randomly assigned to receive either the new daily pill or standard chemotherapy/immunotherapy through a vein drip. Throughout the study, you will have regular check-ups, including imaging scans and blood tests, to monitor your health and how the cancer is responding to the treatment.

The study is currently recruiting participants at several locations in California, including Newport Beach, San Diego, and San Francisco. If your condition worsens while on the standard treatment, you may have the option to switch over to the new study drug.