RecruitingPhase 2NCT06974604

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

Prevention of Datopotamab Deruxtecan (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087)

Sponsor

Brown University

Enrollment

60 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms Lung Neoplasms

Summary

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 the risk of stomatitis, the investigational component of this trial will be to incorporate alcohol-free dexamethasone mouthwash, 10 mL 0.5 mg/5mL oral solution, days 1-5, swish and spit four times daily for the ﬁrst 3 cycles.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a dexamethasone (steroid) mouthwash can prevent or reduce mouth sores (stomatitis) — one of the most common and uncomfortable side effects of a cancer drug called datopotamab deruxtecan (Dato-DXd). **You may be eligible if...** - You have advanced non-small cell lung cancer (non-squamous type) that has progressed after at least one prior treatment - OR you have triple-negative breast cancer that has progressed after at least one prior treatment - OR you have hormone receptor-positive, HER2-negative breast cancer that has progressed and is no longer responding to standard hormone-blocking therapy - You are scheduled to receive or are already receiving Dato-DXd **You may NOT be eligible if...** - You have already developed severe mouth sores from Dato-DXd that required dose reduction - You have uncontrolled infections or other conditions making steroid mouthwash unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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