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.

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07357597
Phase
PHASE4
Status
Recruiting
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Conditions

  • Stomatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone mouthwash — DRUG
    Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone.
  • Datopotamab Deruxtecan (Dato-DXd) — DRUG
    Commercially available Dato-DXd is prescribed and administered to participants according to standard of care

Study Details

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.

Key Dates

First listed
Jan 22, 2026
Start date
Jun 24, 2026
Status verified
Aug 2026
Primary completion
Jan 4, 2028
Completion
Jan 4, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Dexamethasone 0.5 mg/5 mL Mouthwash
    Participants will use dexamethasone 0.5 mg/5 mL alcohol-free mouthwash (10 mL, 4 times daily, swish for approximately 2 minutes, then spit out without swallowing). Participants will remain without food or drink for at least 30 minutes after use of dexamethasone

Primary Outcome Measure

Incidence and severity of Dato-DXd treatment-emergent grade ≥ 2 stomatitis in patients receiving prophylactic dexamethasone mouthwash within first 12 weeks of study treatment [ Time Frame: From date of first dose of study treatment until 12 weeks after date of first dose of study treatment ]

Central Contacts

Locations (39)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85719-
Research SiteHot SpringsArkansas71913-
Research SiteLittle RockArkansas72205-
Research SiteDuarteCalifornia91010-
Research SiteGlendaleCalifornia91204-
Research SiteLakewoodCalifornia90805-
Research SiteLong BeachCalifornia90806-
Research SiteTorranceCalifornia90505-
Research SiteWashington D.C.District of Columbia20037-
Research SitePlantationFlorida33322-
Research SiteAthensGeorgia30607-
Research SiteBoiseIdaho83706-
Research SitePark RidgeIllinois60068-
Research SiteFort WayneIndiana46825-
Research SiteElizabethtownKentucky42701-
Research SiteLexingtonKentucky40503-
Research SiteLexingtonKentucky40509-
Research SiteLouisvilleKentucky40207-
Research SiteNew OrleansLouisiana70112-
Research SiteFrederickMaryland21702-
Research SiteGlenn DaleMaryland20769-
Research SiteDetroitMichigan48202-
Research SiteGraylingMichigan49738-
Research SiteMinneapolisMinnesota55426-
Research SiteKansas CityMissouri64111-
Research SiteRenoNevada89502-
Research SiteLebanonNew Hampshire03756-
Research SiteEast SyracuseNew York13057-
Research SiteWestburyNew York11590-
Research SiteWhite PlainsNew York10601-
Research SiteGreensboroNorth Carolina27403-
Research SiteWilsonNorth Carolina27893-
Research SiteClevelandOhio44106-
Research SiteWynnewoodPennsylvania19096-
Research SiteKnoxvilleTennessee37920-
Research SiteFairfaxVirginia22031-
Research SiteCharlestonWest Virginia25304-
Research SiteMorgantownWest Virginia26506-
Research SiteWaukeshaWisconsin53188-

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