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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 is a Phase 4 study that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 100 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07357597
The ClinicalTrials.gov registry entry for NCT07357597 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Datopotamab Deruxtecan (Dato-DXd) is the first listed.
NCT07357597 reports 0 study locations.
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.
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