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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.

Study acronym: TROPION-SWISH
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 39 to 40 Eligibility criteria expanded, about 22 words · Secondary endpoints: details revised at 6 of 7 entries · Study description expanded, about 2 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 6 of 7 entries
    • Study description expanded, about 2 words
  2. Re-verified, no change to tracked fieldsv4
  3. Site details revised at 3 of 39 sitesv3
  4. Recruitment opened Start date changed from estimate of Feb 27, 2026 to Jun 24, 2026 · Primary and study completion pushed from Oct 9, 2027 to Jan 4, 2028 · Trial sites expanded: 20 → 39 locationsv2 Show 3 more changesShow less
    • Start date changed from estimate of Feb 27, 2026 to Jun 24, 2026
    • Primary and study completion pushed from Oct 9, 2027 to Jan 4, 2028
    • Trial sites expanded: 20 → 39 locations
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
727 trials monitored
See 61 trials at risk
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
Trial Details
NCT Number NCT07357597
Lead Sponsor AstraZeneca
Collaborators: Daiichi Sankyo
Conditions Stomatitis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov