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StomatitisPhase 4TROPION-SWISHNCT07357597

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 4 study testing Dexamethasone mouthwash and Datopotamab Deruxtecan (Dato-DXd) in people with Stomatitis, run by AstraZeneca at 40 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stomatitis
What is being tested?
Dexamethasone mouthwash and Datopotamab Deruxtecan (Dato-DXd)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
40 sitesUnited States
Study dates
24 Jun 2026to 4 Jan 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are eligible to be included in the study only if all the following criteria apply:
  • Disease Characteristics
  • 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.
Show all 18Show fewer
  • OR
  • Patients with locally advanced or metastatic EGFRm NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy.
  • Age
  • Patient must be ≥ 18 years, at the time of signing the informed consent.
  • Type of Patient and Disease Characteristics-
  • Has documentation that Dato-DXd will be prescribed for the labelled indication and has not received any dose of Dato-DXd prior to enrollment.
  • Is willing to comply with use of prophylactic dexamethasone mouthwash at the start of first infusion and throughout Dato-DXd administration.
  • ECOG performance status 0 or 1.
  • Has adequate bone marrow function (hemoglobin ≥ 9 g/dL; red blood cell/plasma transfusion is not allowed within 1 week prior to screening assessment).
  • All women of childbearing potential must have a negative serum pregnancy test result at screening.
  • Informed Consent
  • 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.

Who cannot join

  • Patients are excluded from the study if any of the following criteria apply:
  • Has received Dato-DXd prior to enrollment.
  • Medical Conditions
  • 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.
  • Has any-grade active and uncontrolled stomatitis or mouth ulcers at baseline (participants with prior medical history of stomatitis or mouth ulcers are eligible).
  • Use of steroid-containing mouthwash is contraindicated in, including but not limited to:
Show all 17Show fewer
  • 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
  • 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).
  • Has clinically significant corneal disease.
  • Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients of Dato-DXd (including, but not limited to, polysorbate 80).
  • Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
  • Is pregnant, or breastfeeding, or planning to become pregnant.
  • Other Exclusions
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • 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.
  • Previous enrollment in the present study.

Trial locations and contacts

40 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

40 sites in 1 country

United States40 sites, 31 recruiting

  • Research Site

    Athens, Georgia, 30607

    Recruiting

  • Research Site

    Boise, Idaho, 83706

    Withdrawn

  • Research Site

    Charleston, West Virginia, 25304

    Withdrawn

  • Research Site

    Cleveland, Ohio, 44106

    Not yet recruiting

  • Research Site

    Detroit, Michigan, 48202

    Not yet recruiting

  • Research Site

    Duarte, California, 91010

    Not yet recruiting

  • Research Site

    East Syracuse, New York, 13057

    Recruiting

  • Research Site

    Elizabethtown, Kentucky, 42701

    Recruiting

  • Research Site

    Fairfax, Virginia, 22031

    Not yet recruiting

  • Research Site

    Fort Wayne, Indiana, 46825

    Recruiting

  • Research Site

    Frederick, Maryland, 21702

    Withdrawn

  • Research Site

    Glendale, California, 91204

    Recruiting

  • Research Site

    Glenn Dale, Maryland, 20769

    Not yet recruiting

  • Research Site

    Grayling, Michigan, 49738

    Recruiting

  • Research Site

    Greensboro, North Carolina, 27403

    Not yet recruiting

  • Research Site

    Hot Springs, Arkansas, 71913

    Recruiting

  • Research Site

    Kansas City, Missouri, 64111

    Not yet recruiting

  • Research Site

    Knoxville, Tennessee, 37920

    Recruiting

  • Research Site

    Lakewood, California, 90805

    Recruiting

  • Research Site

    Lebanon, New Hampshire, 03756

    Withdrawn

  • Research Site

    Lexington, Kentucky, 40503

    Recruiting

  • Research Site

    Lexington, Kentucky, 40509

    Not yet recruiting

  • Research Site

    Little Rock, Arkansas, 72205

    Recruiting

  • Research Site

    Long Beach, California, 90806

    Recruiting

  • Research Site

    Louisville, Kentucky, 40207

    Recruiting

  • Research Site

    Minneapolis, Minnesota, 55426

    Recruiting

  • Research Site

    Morgantown, West Virginia, 26506

    Not yet recruiting

  • Research Site

    New Orleans, Louisiana, 70112

    Not yet recruiting

  • Research Site

    Park Ridge, Illinois, 60068

    Withdrawn

  • Research Site

    Plantation, Florida, 33322

    Not yet recruiting

  • Research Site

    Reno, Nevada, 89502

    Withdrawn

  • Research Site

    Torrance, California, 90505

    Not yet recruiting

  • Research Site

    Tucson, Arizona, 85719

    Withdrawn

  • Research Site

    Washington D.C., District of Columbia, 20037

    Withdrawn

  • Research Site

    Waukesha, Wisconsin, 53188

    Recruiting

  • Research Site

    West Columbia, South Carolina, 29169

    Not yet recruiting

  • Research Site

    Westbury, New York, 11590

    Not yet recruiting

  • Research Site

    White Plains, New York, 10601

    Withdrawn

  • Research Site

    Wilson, North Carolina, 27893

    Recruiting

  • Research Site

    Wynnewood, Pennsylvania, 19096

    Recruiting

Other trials in United States

About this study

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)

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

Read the 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.

Conditions
Stomatitis
Being tested
Dexamethasone mouthwash, Datopotamab Deruxtecan (Dato-DXd)
Medical subject headings
Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone mouthwashDrug

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

  • Datopotamab Deruxtecan (Dato-DXd)Drug

    Also called Datroway

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

Study groups in NCT07357597
Study groupRoleWhat they receive
Dexamethasone 0.5 mg/5 mL MouthwashExperimentalParticipants 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
Receives: Drug: Dexamethasone mouthwash; Drug: Datopotamab Deruxtecan (Dato-DXd)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of Dato-DXd treatment-emergent grade ≥ 2 stomatitis in patients receiving prophylactic dexamethasone mouthwash within first 12 weeks 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).

    Measured: From date of first dose of study treatment until 12 weeks after date of first dose of study treatment

Secondary outcomes (7)

  1. Incidence and severity of Dato-DXd treatment-emergent grade ≥ 2 stomatitis

    This will be determined using the composite stomatitis definition in the primary outcome. Will be repeated within 6 weeks and within 9 weeks of study treatment.

    Measured: From date of first dose of study treatment until 6 and 9 weeks after date of first dose of study treatment

  2. Incidence and severity of treatment-emergent stomatitis overall, by maximum CTCAE grade, and CTCAE grade ≥ 2

    This will be determined using stomatitis CTCAE grade only. Will be analysed at 6, 9 and 12 weeks.

    Measured: From date of first dose of study treatment until 6, 9 and 12 weeks after date of first dose of study treatment

  3. Time to onset of grade ≥ 2 stomatitis

    The time (in days) from the date of the first dose of Dato-DXd to the date of first onset to a grade ≥ 2 stomatitis event. The measure of primary interest is median time to onset.

    Measured: From date of first dose until earliest of diagnosis of grade ≥2 stomatitis, Dato-DXD discontinuation and death, whichever occurs first, assessed up to approximately 21 months

  4. Time to resolution of Dato-DXd-related grade ≥ 2 stomatitis

    Number of days from the date of onset of stomatitis grade ≥ 2 until the earliest date of event resolved or reduced in severity to grade 1. The measure of primary interest is median time to resolution.

    Measured: From date of diagnosis of grade ≥2 stomatitis until the earliest date of event resolved or reduced in severity to grade 1, assessed up to approximately 21 months

  5. Proportion of participants with a dose modification for Dato-DXd due to stomatitis

    Dose modification is defined as dose reduction, delay, or discontinuation due to stomatitis Treatment-Emergent Adverse Event (TEAE).

    Measured: From date of first dose until earliest of Dato-DXD discontinuation and death, assessed up to approximately 21 months

  6. Participant adherence to dexamethasone mouthwash

    Adherence to dexamethasone mouthwash will be assessed by cohort using the Daily Activities Diary. The measure of primary interest is the median number of swished mouthwashes per day.

    Measured: From date of first dose of study treatment until 12 weeks after date of first dose of study treatment

  7. Safety and tolerability of Dato-DXd in participants receiving prophylactic dexamethasone mouthwash

    Safety and tolerability will be evaluated by cohort in terms of AEs (graded by NCI-CTCAE v5.0) and in terms of the following:

    • Incidence and severity of TEAEs and Serious Adverse Events (SAEs), including oral infections (such as fungal infections) associated with the use of the dexamethasone mouthwash
    • Eastern Cooperative Oncology Group (ECOG) performance status
    • Vital signs and physical examination
    • Clinical chemistry, hematology, urinalysis, and coagulation assessments
    • Use of antifungal medication for treating dexamethasone-related fungal infection.

    Measured: From date of first dose of study intervention until 28 days after the last dose (Safety Follow-up), approximately 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start24 Jun 2026
  3. Primary completion4 Jan 2028 (estimated)
  4. Study completion4 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07357597
Sponsor's protocol ID
D926UL00001
Acronym
TROPION-SWISH
Status last verified
Sep 2026
First submitted
21 Jan 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone mouthwash and Datopotamab Deruxtecan (Dato-DXd) in people with Stomatitis, run by AstraZeneca at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07357597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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