Study of BAY2927088 for Adults with Advanced Non-small Cell Lung Cancer Having EGFR andor HER2 Gene Mutations

What this Trial Is About

Researchers are investigating new treatments for people with advanced non-small cell lung cancer NSCLC that has spread to nearby tissues or other parts of the body. This study focuses on cancers with mutations in the epidermal growth factor receptor EGFR andor human epidermal growth factor receptor 2 HER2 genes. These mutations cause abnormal proteins that promote cancer growth and spread, and the study aims to learn how a new drug, sevabertinib BAY2927088, affects these mutated proteins and the cancer. The study has four parts dose escalation, backfill, expansion, and extension. Participants will take sevabertinib orally once or twice daily in 3-week cycles. The dose will be gradually increased in the escalation part to find the highest tolerated dose. The backfill part tests these doses in more people to find optimal safe doses. The expansion part confirms the dose to use in future studies, and the extension part evaluates how well this dose works. Participants will continue treatment until their cancer worsens, they experience medical problems, leave the study, or the study ends. During the study, participants will have regular blood and urine tests, imaging scans like CT or MRI to check cancer status, heart health assessments, and be asked about how they feel and any side effects. Researchers will monitor safety by tracking adverse events, dose limits, and drug levels in the blood. The main outcomes include measuring side effects, maximum tolerated dose, and how well the treatment shrinks tumors. Participants may be involved in the study for several years to assess long-term safety and effectiveness.

First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)