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.
Start Date
6/24/2026
Completion Date
1/4/2028
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.
Detailed Description
The purpose of this Phase IV study is to describe the incidence and severity of Dato-DXd treatment-emergent grade ≥ 2 stomatitis in participants receiving prophylactic dexamethasone mouthwash within the first 12 weeks of study treatment (ie, Dato-DXd dosing). The study will enroll an estimated 100 participants across approximately 35 sites in the U.S. Enrollment of participants is planned to occur over approximately 18 months, with a minimum of 12 weeks of follow-up for each participant after the first Dato-DXd dose. This study has one arm, and the study population will consist of 2 independent cohorts (approximately 50 participants in each cohort): * Breast cohort (Cohort 1) * Lung cohort (Cohort 2) Participants will receive the study intervention, dexamethasone mouthwash, throughout the duration of their standard of care treatment with Dato-DXd.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Dexamethasone mouthwash
Datopotamab Deruxtecan (Dato-DXd)
Conditions
Locations
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Tucson, Arizona 85719
United States
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Hot Springs, Arkansas 71913
United States
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Little Rock, Arkansas 72205
United States
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Duarte, California 91010
United States
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Glendale, California 91204
United States
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Lakewood, California 90805
United States
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Long Beach, California 90806
United States
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Torrance, California 90505
United States
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Washington D.C., District of Columbia 20037
United States
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Plantation, Florida 33322
United States
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Athens, Georgia 30607
United States
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Boise, Idaho 83706
United States
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Park Ridge, Illinois 60068
United States
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Fort Wayne, Indiana 46825
United States
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Elizabethtown, Kentucky 42701
United States
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Lexington, Kentucky 40503
United States
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Lexington, Kentucky 40509
United States
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Louisville, Kentucky 40207
United States
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New Orleans, Louisiana 70112
United States
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Frederick, Maryland 21702
United States
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Glenn Dale, Maryland 20769
United States
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Detroit, Michigan 48202
United States
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Grayling, Michigan 49738
United States
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Minneapolis, Minnesota 55426
United States
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Kansas City, Missouri 64111
United States
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Reno, Nevada 89502
United States
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Lebanon, New Hampshire 03756
United States
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East Syracuse, New York 13057
United States
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Westbury, New York 11590
United States
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White Plains, New York 10601
United States
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Greensboro, North Carolina 27403
United States
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Wilson, North Carolina 27893
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Cleveland, Ohio 44106
United States
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Wynnewood, Pennsylvania 19096
United States
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Knoxville, Tennessee 37920
United States
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Fairfax, Virginia 22031
United States
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Charleston, West Virginia 25304
United States
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Morgantown, West Virginia 26506
United States
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Waukesha, Wisconsin 53188
United States