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

Completed

• Conditions: Advanced/Metastatic NSCLC; Advanced/Metastatic HER2-negative Breast Cancer

• Registration Number: NCT06686602
• Lead Sponsor: Daiichi Sankyo

Brief 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.

Study Timeline

• Study Start: 2024-07-09
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-13
• Primary Completion: 2024-12-16
• Status Verified: 2025-03
• Study Completion: 2025-03-18
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13759

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Demographics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE	From NSCLC diagnosis (01 January 2015) or Breast Cancer diagnosis (01 January 2012) up to until death, exit from the database, or March 31, 2024, whichever comes first (approximately 12 years 2 months)
Clinical Characteristics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE	From NSCLC diagnosis (01 January 2015) or Breast Cancer diagnosis (01 January 2012) up to until death, exit from the database, or March 31, 2024, whichever comes first (approximately 12 years 2 months)

Trial Locations

Locations (1)

ConcertAI Database; 🇺🇸 Cambridge, Massachusetts, United States