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.
← catalyst calendarNCT07357597 · readout in 502 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.
Phase
Phase 4
Status
Recruiting
Study type
Interventional
Design
Na · None · Prevention
Enrollment
100estimated
Sites
39
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-06-24 | actual | When the study began enrolling |
| Primary completion | 2028-01-04 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-01-04 | estimated | The whole study's end, after follow-up |
| First posted | 2026-01-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Stomatitis
Interventions
- Drug: Dexamethasone mouthwash
- Drug: Datopotamab Deruxtecan (Dato-DXd) — also filed as Datroway
Primary outcome
what the primary-completion date above is the date OFIncidence and severity of Dato-DXd treatment-emergent grade ≥ 2 stomatitis in patients receiving prophylactic dexamethasone mouthwash within first 12 weeks of study treatment
measured From date of first dose of study treatment until 12 weeks after date of first dose of study treatment
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