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.

ClinicalTrials.gov ID: NCT07357597

Public ClinicalTrials.gov record NCT07357597. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 9:16 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07357597
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 4
Lead sponsor: AstraZeneca; Industry
Enrollment: 100 participants

Conditions and interventions

Conditions

Stomatitis

Interventions

Dexamethasone mouthwash Drug
Datopotamab Deruxtecan (Dato-DXd) Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 23, 2026
Primary completion: Jan 3, 2028
Completion: Jan 3, 2028
Last update posted: Aug 4, 2026

2026 – 2028

United States locations

U.S. sites: 39
U.S. states: 25
U.S. cities: 38

Facility	City	State	ZIP	Site status
Research Site	Tucson	Arizona	85719	Withdrawn
Research Site	Hot Springs	Arkansas	71913	Recruiting
Research Site	Little Rock	Arkansas	72205	Recruiting
Research Site	Duarte	California	91010	Not yet recruiting
Research Site	Glendale	California	91204	Recruiting
Research Site	Lakewood	California	90805	Recruiting
Research Site	Long Beach	California	90806	Recruiting
Research Site	Torrance	California	90505	Not yet recruiting
Research Site	Washington D.C.	District of Columbia	20037	Withdrawn
Research Site	Plantation	Florida	33322	Not yet recruiting
Research Site	Athens	Georgia	30607	Recruiting
Research Site	Boise	Idaho	83706	Withdrawn
Research Site	Park Ridge	Illinois	60068	Withdrawn
Research Site	Fort Wayne	Indiana	46825	Recruiting
Research Site	Elizabethtown	Kentucky	42701	Not yet recruiting
Research Site	Lexington	Kentucky	40503	Not yet recruiting
Research Site	Lexington	Kentucky	40509	Not yet recruiting
Research Site	Louisville	Kentucky	40207	Not yet recruiting
Research Site	New Orleans	Louisiana	70112	Not yet recruiting
Research Site	Frederick	Maryland	21702	Withdrawn
Research Site	Glenn Dale	Maryland	20769	Not yet recruiting
Research Site	Detroit	Michigan	48202	Not yet recruiting
Research Site	Grayling	Michigan	49738	Not yet recruiting
Research Site	Minneapolis	Minnesota	55426	Recruiting
Research Site	Kansas City	Missouri	64111	Not yet recruiting
Research Site	Reno	Nevada	89502	Withdrawn
Research Site	Lebanon	New Hampshire	03756	Withdrawn
Research Site	East Syracuse	New York	13057	Recruiting
Research Site	Westbury	New York	11590	Not yet recruiting
Research Site	White Plains	New York	10601	Withdrawn
Research Site	Greensboro	North Carolina	27403	Not yet recruiting
Research Site	Wilson	North Carolina	27893	Recruiting
Research Site	Cleveland	Ohio	44106	Not yet recruiting
Research Site	Wynnewood	Pennsylvania	19096	Recruiting
Research Site	Knoxville	Tennessee	37920	Not yet recruiting
Research Site	Fairfax	Virginia	22031	Not yet recruiting
Research Site	Charleston	West Virginia	25304	Withdrawn
Research Site	Morgantown	West Virginia	26506	Not yet recruiting
Research Site	Waukesha	Wisconsin	53188	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07357597, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 4, 2026 · Synced Sep 2, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07357597 live on ClinicalTrials.gov.

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