drugset / Trial / NCT07357597

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.

NCT07357597

Phase 4 Recruiting 100 enrolled AstraZeneca Daiichi Sankyo · collab
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2026-06-24
Primary completion
2028-01-04
Completion
2028-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 1 mg Oral
Background Datopotamab deruxtecan Monoclonal antibody

Indications