Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM

TROPION-DM/BrUOG-431 is a prospective, , phase 2 trial with two non-comparative cohorts analyzed jointly for primary endpoint in adult patients with either (Cohort 1:) advanced/metastatic hormone-receptor positive (\[HR+\], estrogen receptor and/or progesterone receptor positive) breast cancer (BC), or advanced/metastatic triple negative breast cancer (TNBC) or (Cohort 2:) advanced/metastatic non-squamous non-small cell lung cancer (NSCLC). All patients will be treated with Datopotumab deruxtecan (Dato-DXd) at 6 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity. Due to

Trial Details

NCT ID
NCT06974604
Phase
PHASE2
Sponsor
Brown University
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Dexamethasone oral
Locations (sample)
  • Providence, Rhode Island, United States|41.82399,-71.41283

Key Eligibility Criteria

  • Has advanced and/or metastatic cancer that meets one of the following criteria:
  • Pathologically documented unresectable advanced non-squamous NSCLC not amenable to curative therapy that has progressed on at least one prior therapy.
  • Pathologically documented triple negative breast cancer (estrogen receptor negative and progesterone receptor negative and HER2 negative) who have …
  • Pathologically documented hormone receptor positive breast cancer (estrogen receptor and/or progesterone receptor positive, HER2 negative) which ha…

For full eligibility, visit ClinicalTrials.gov.

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