This is a multicenter, open-label, single-arm study of prophylaxis for Dato-DXd-related
stomatitis in eligible patients with metastatic or inoperable locally recurrent breast
cancer or locally advanced or metastatic Epidermal Growth Factor Receptor-Mutated (EGFRm)
non-small cell lung cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07357597.
The purpose of this Phase IV study is to describe the incidence and severity of Dato-DXd
treatment-emergent grade ≥ 2 stomatitis in participants receiving prophylactic
dexamethasone mouthwash within the first 12 weeks of study treatment (ie, Dato-DXd
dosing).
The study will enroll an estimated 100 participants across approximately 35 sites in the
U.S. Enrollment of participants is planned to occur over approximately 18 months, with a
minimum of 12 weeks of follow-up for each participant after the first Dato-DXd dose.
This study has one arm, and the study population will consist of 2 independent cohorts
(approximately 50 participants in each cohort):
- Breast cohort (Cohort 1)
- Lung cohort (Cohort 2)
Participants will receive the study intervention, dexamethasone mouthwash, throughout the
duration of their standard of care treatment with Dato-DXd.
Lead OrganizationAstraZeneca Pharmaceuticals LP