Clinical Trial

An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (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 Non-small Cell Lung Cancer.

Study acronym: TROPION-SWISH
Recruiting Phase 4
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Summary
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.
Protocol Amendment History 4 changes
critical Recruitment opened 2026-07-11
notable Trial sites expanded: 20 -> 39 locations 2026-07-11
notable Primary completion pushed: 2027-10-09 -> 2028-01-04 2026-07-11
minor Completion pushed: 2027-10-09 -> 2028-01-04 2026-07-11
Trial Details
NCT Number NCT07357597
Lead Sponsor AstraZeneca
Collaborators: Daiichi Sankyo
Conditions Stomatitis
Enrollment 100 participants
Start Date 2026-06-24
Primary Completion 2028-01-04 (estimated)
Study Completion 2028-01-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-05