NCT06686602

A Study Assessing Risk Factors for Oral Mucositis/Stomatitis and Ocular Surface Events in NSCLC and Breast Cancer

Assessing Risk Factors Associated With the Onset of Oral Mucositis/Stomatitis and Ocular Surface Events (OSE) in Patients With Non-small Cell Lung Cancer (NSCLC) and HER2-negative Breast Cancer (BC)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13,759 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will identify risk factors for oral mucositis/stomatitis and ocular surface events (OSE) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) and advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Detailed description

It is important to identify risk factors for the onset of oral mucositis/stomatitis and OSE to identify high-risk patients who will be taking Dato-DXd. Understanding these risk factors in patients receiving standard-of-care anti-cancer therapies may also help with mitigation strategies. This objective will be achieved by identifying and describing patient demographics and clinical characteristics of cases with oral mucositis/stomatitis and OSE. No study drug will be provided or administered for this study.

Conditions

• Advanced/Metastatic NSCLC
• Advanced/Metastatic HER2-negative Breast Cancer

Interventions

Type	Name	Description
OTHER	No drug	This is a non-interventional study and no study drug will be administered.

Timeline

• Start date: 2024-07-09
• Primary completion: 2024-12-16
• Completion: 2025-03-18
• First posted: 2024-11-13
• Last updated: 2025-03-19

Locations

1 site across 1 country: United States