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Recruiting Phase 4

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.

NCT07357597 · tracked via the Priya Life Science USA tracker
Phase
Phase 4
Started
2026-06-24
Last updated
2026-10-28

Condition(s) studied

Stomatitis

Investigational drug(s) / intervention(s)

Dexamethasone mouthwashDatopotamab Deruxtecan (Dato-DXd) →

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

Datopotamab Deruxtecan (Dato-DXd): Commercially available Dato-DXd is prescribed and administered to participants according to standard of care

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Patients are eligible to be included in the study only if all the following criteria apply: Disease Characteristics 1. Patients with any of the following disease characteristics are eligible (specific population subject to FDA Dato-DXd label): • Patients with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received prior ET and chemotherapy for unresectable or metastatic disease. OR • Adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Participants will be enrolled upon FDA approval on use of Dato-DXd for this indication. OR • Patients with locally advanced or metastatic EGFRm NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy. Age 2. Patient must be ≥ 18 years, at the time of signing the informed consent. Type of Patient and Disease Characteristics- 3. Has documentation that Dato-DXd will be prescribed for the labelled indication and has not received any dose of Dato-DXd prior to enrollment. 4. Is willing to comply with use of prophylactic dexamethasone mouthwash at the start of first infusion and throughout Dato-DXd administration. 5. ECOG performance status 0 or 1. 6. Has adequate bone marrow function (hemoglobin ≥ 9 g/dL; red blood cell/plasma transfusion is not allowed within 1 week prior to screening assessment). 7. All women of childbearing potential must have a negative serum pregnancy test result at screening. Informed Consent 8. Capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the ICF and the protocol. Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: 1. Has received Dato-DXd prior to enrollment. Medical Conditions 2. As judged by the investigator, any evidence of cardiac, pulmonary, vascular, and other renal conditions which in the investigator's opinion makes it undesirable for the patient to participate in the study. 3. Has any-grade active and uncontrolled stomatitis or mouth ulcers at baseline (participants with prior medical history of stomatitis or mouth ulcers are eligible). 4. Use of steroid-containing mouthwash is contraindicated in, including but not limited to: * Active oral infections (eg, viral, bacterial, or fungal), where the use of a steroid-containing mouthwash may impair local immune response and delay healing * Known hypersensitivity or allergy to corticosteroids or any excipients contained in the mouthwash formulation 5. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections (participants with localized fungal infections of skin or nails are eligible). 6. Has clinically significant corneal disease. 7. Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients of Dato-DXd (including, but not limited to, polysorbate 80). 8. Has a history of severe hypersensitivity reactions to other monoclonal antibodies. 9. Is pregnant, or breastfeeding, or planning to become pregnant. Other Exclusions 10. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 11. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements. 12. Previous enrollment in the present study.

Primary outcome measure(s)

  • Incidence and severity of Dato-DXd treatment-emergent grade ≥ 2 stomatitis in patients receiving prophylactic dexamethasone mouthwash within first 12 weeks of study treatment — From date of first dose of study treatment until 12 weeks after date of first dose of study treatment
    Incidence is defined as the proportion of participants who develop National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 grade ≥ 2 stomatitis accompanied by either a Normalcy of Diet Subscale score ≤ 50 and/or a Numeric Rating Scale (NRS) oral-pain score of 7 on 2 consecutive days or 8, 9, or 10 on any one day. Severity will be based on the highest NCI-CTCAE v5.0 grade of stomatitis experienced by each participant. CTCAE displays Grades 1-5 with descriptions of severity for each adverse event (AE). Grade 1 for mild symptoms and Grade 5 for death related to AE. The Normalcy of Diet Subscale assesses the degree to which a patient can eat a normal diet and drink liquids. The scale is a ranking of 10 food categories, from easy-to-eat to difficult-to-eat. The Numeric Rating Scale is a scale for self-reporting of pain. Scores range from 0-10, with higher scores meaning the worst pain possible (0=no pain to 10=worst possible pain).

Trial sites (41)

FacilityCityRegionStatus
Research Site Tucson Arizona Withdrawn
Research Site Hot Springs Arkansas Recruiting
Research Site Little Rock Arkansas Recruiting
Research Site Duarte California Not Yet Recruiting
Research Site Glendale California Recruiting
Research Site Lakewood California Recruiting
Research Site Long Beach California Recruiting
Research Site Torrance California Not Yet Recruiting
Research Site Washington D.C. District of Columbia Withdrawn
Research Site Coral Springs Florida Recruiting
Research Site Plantation Florida Recruiting
Research Site Athens Georgia Recruiting
Research Site Boise Idaho Withdrawn
Research Site Park Ridge Illinois Withdrawn
Research Site Fort Wayne Indiana Recruiting
Research Site Elizabethtown Kentucky Recruiting
Research Site Lexington Kentucky Recruiting
Research Site Lexington Kentucky Not Yet Recruiting
Research Site Louisville Kentucky Recruiting
Research Site New Orleans Louisiana Not Yet Recruiting
Research Site Frederick Maryland Withdrawn
Research Site Glenn Dale Maryland Not Yet Recruiting
Research Site Detroit Michigan Not Yet Recruiting
Research Site Grayling Michigan Recruiting
Research Site Minneapolis Minnesota Recruiting
Research Site Kansas City Missouri Recruiting
Research Site Reno Nevada Withdrawn
Research Site Lebanon New Hampshire Withdrawn
Research Site East Syracuse New York Recruiting
Research Site Westbury New York Not Yet Recruiting
Research Site White Plains New York Withdrawn
Research Site Greensboro North Carolina Not Yet Recruiting
Research Site Wilson North Carolina Recruiting
Research Site Cleveland Ohio Not Yet Recruiting
Research Site Wynnewood Pennsylvania Recruiting
Research Site West Columbia South Carolina Not Yet Recruiting
Research Site Knoxville Tennessee Recruiting
Research Site Fairfax Virginia Recruiting
Research Site Charleston West Virginia Withdrawn
Research Site Morgantown West Virginia Recruiting

+ 1 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07357597 on ClinicalTrials.gov ↗ ← All trials in the USA