RecruitingPhase 4NCT07357597

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.

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-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 (TROPION-SWISH)


Sponsor

AstraZeneca

Enrollment

100 participants

Start Date

Jun 24, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Datopotamab Deruxtecan (Dato-DXd) and a drug called Dexamethasone mouthwash for people with stomatitis. The study is currently recruiting participants at 39 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexamethasone mouthwash

Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone.

DRUGDatopotamab Deruxtecan (Dato-DXd)

Commercially available Dato-DXd is prescribed and administered to participants according to standard of care


Locations(39)

Research Site

Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Duarte, California, United States

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Glendale, California, United States

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Lakewood, California, United States

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Long Beach, California, United States

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Torrance, California, United States

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Washington D.C., District of Columbia, United States

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Plantation, Florida, United States

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Athens, Georgia, United States

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Boise, Idaho, United States

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Park Ridge, Illinois, United States

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Fort Wayne, Indiana, United States

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Elizabethtown, Kentucky, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Frederick, Maryland, United States

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Glenn Dale, Maryland, United States

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Detroit, Michigan, United States

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Grayling, Michigan, United States

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Minneapolis, Minnesota, United States

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Kansas City, Missouri, United States

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Reno, Nevada, United States

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Lebanon, New Hampshire, United States

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East Syracuse, New York, United States

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Westbury, New York, United States

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White Plains, New York, United States

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Greensboro, North Carolina, United States

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Wilson, North Carolina, United States

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Cleveland, Ohio, United States

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Wynnewood, Pennsylvania, United States

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Knoxville, Tennessee, United States

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Fairfax, Virginia, United States

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Charleston, West Virginia, United States

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Morgantown, West Virginia, United States

Research Site

Waukesha, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07357597


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