About this trial
This trial is looking at how to prevent mouth sores from a treatment called Datopotamab deruxtecan (Dato-DXd) in people with advanced cancer. It focuses on patients with HER2-negative metastatic breast cancer or non-small cell lung cancer. The goal is to see if using a special mouthwash can help reduce the chance of getting these sores while receiving the treatment.
This trial is identified by NCT06974604. It is a Phase 2 trial, which means it is looking at how well the treatment works and how safe it is. This study is regulated by the FDA and aims to include about 60 participants.
Who can join
Adults aged 18 and older can join this trial. It is open to both men and women with certain types of advanced cancer. Participants should have measurable disease and acceptable organ function. Those who have had recent surgeries or certain therapies need to meet specific recovery times before joining. The trial team will confirm who is eligible.
Conditions
Breast Neoplasms, Lung Neoplasms
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Everyone in the trial will receive Dexamethasone mouthwash for the first three cycles of treatment with Dato-DXd. This mouthwash is used to help prevent mouth sores. Participants will take Dato-DXd by IV every three weeks and use the mouthwash for the first five days of each cycle.
Where
This trial is running at 1 location in the United States. It is currently recruiting.
Rhode Island and the Miriam Hospitals (Brown University Health)
Providence, Rhode Island