Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrown University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 progressed on at least 1 prior line of therapy or in the opinion of the treating physician, not be a candidate for standard first-line metastatic breast cancer therapy
Pathologically documented hormone receptor positive breast cancer (estrogen receptor and/or progesterone receptor positive, HER2 negative) which has progressed on hormonal based therapy including CDK4/6 inhibitor and 1 prior line of chemotherapy and/or antibody drug conjugate therapy.
Aged ≥18 years.
Disqualifiers
Active second malignancy which would alter interpretation of study results.
Has a history of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Has clinically significant corneal disease
Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd.
Trial design
Design model
Single group
Treatments tested in this trial
Dexamethasone oral
DrugDexamethasone 10 mL daily for days 1-5 for each of the first 3 cycles of therapy Datopotamab Deruxtecan 6.0 mg/kg IV on day 1 every 21 days
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Dexamethasone 10mLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Lower the incidence of all stomatitis
Lower the incidence of all stomatitis by 20%
Time frame
Approximately 9 weeksSecondary outcomes
1
Clinical benefit
Clinical benefit rate
Time frame
Approximately 9 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov