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
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

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

Start date
Feb 27, 2026
Status verified
Jan 2026
Primary completion
Oct 9, 2027
Completion
Oct 9, 2027

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 (20)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85719-
Research SiteHot SpringsArkansas71913-
Research SiteLittle RockArkansas72205-
Research SiteDuarteCalifornia91010-
Research SiteGlendaleCalifornia91204-
Research SiteLakewoodCalifornia90805-
Research SiteTorranceCalifornia90505-
Research SiteAthensGeorgia30607-
Research SitePark RidgeIllinois60068-
Research SiteFort WayneIndiana46825-
Research SiteLexingtonKentucky40503-
Research SiteLouisvilleKentucky40207-
Research SiteDetroitMichigan48202-
Research SiteRenoNevada89502-
Research SiteWestburyNew York11590-
Research SiteGreensboroNorth Carolina27403-
Research SiteClevelandOhio44106-
Research SiteKnoxvilleTennessee37920-
Research SiteFairfaxVirginia22031-
Research SiteMilwaukeeWisconsin64111-

Find similar trials in Tucson, AZ

By research site
Research Site· Tucson, AZResearch Site· Hot Springs, ARResearch Site· Little Rock, ARResearch Site· Duarte, CAResearch Site· Glendale, CAResearch Site· Lakewood, CA

Related Studies