Clinical Trial

Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM

Recruiting Phase 2
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Summary
TROPION-DM/BrUOG-431 is a prospective, , phase 2 trial with two non-comparative cohorts analyzed jointly for primary endpoint in adult patients with either (Cohort 1:) advanced/metastatic hormone-receptor positive (\[HR+\], estrogen receptor and/or progesterone receptor positive) breast cancer (BC), or advanced/metastatic triple negative breast cancer (TNBC) or (Cohort 2:) advanced/metastatic non-squamous non-small cell lung cancer (NSCLC). All patients will be treated with Datopotumab deruxtecan (Dato-DXd) at 6 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity. Due to the risk of stomatitis, the investigational component of this trial will be to incorporate alcohol-free dexamethasone mouthwash, 10 mL 0.5 mg/5mL oral solution, days 1-5, swish and spit four times daily for the first 3 cycles.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-05-08; most recent amendment 2025-10-23.
Status change: Not Yet Recruiting → Recruiting 2025-10-23
Trial Details
NCT Number NCT06974604
Lead Sponsor Brown University
Collaborators: Rhode Island Hospital, The Miriam Hospital
Conditions Breast Neoplasms, Lung Neoplasms
Enrollment 60 participants
Start Date 2025-10-22
Primary Completion 2027-05-31 (estimated)
Study Completion 2029-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-24