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NCT07357597 · ClinicalTrials.gov registry record · 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.
A Phase 4 study, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT07357597: Recruiting Phase 4 study, sponsored by AstraZeneca.
NCT07357597 is a Phase 4 study that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07357597, a Phase 4 study, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
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.
Primary Outcome
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
Interventions
- DRUG Datopotamab Deruxtecan (Dato-DXd)
- DRUG Dexamethasone mouthwash
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-06-24 |
| Est. Completion | 2028-01-04 |
| Phase | Phase 4 |
What NCT07357597 shows while recruiting
NCT07357597 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Datopotamab Deruxtecan (Dato-DXd) is the first listed.
NCT07357597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07357597 about?
NCT07357597 is a clinical study titled "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.". 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.
What is the current status of trial NCT07357597?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2026-06-24. Estimated completion is 2028-01-04.
What interventions are being tested in trial NCT07357597?
The interventions under investigation include: Datopotamab Deruxtecan (Dato-DXd) (DRUG), Dexamethasone mouthwash (DRUG).
Who is sponsoring clinical trial NCT07357597?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07357597's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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