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

Last updated: March 18, 2025
Sponsor: Daiichi Sankyo
Overall Status: Completed

Phase

N/A

Condition

Mucositis

Treatment

No drug

Clinical Study ID

NCT06686602
DS1062-0008-NIS-EPI
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  1. The inclusion criteria for the NSCLC cohort consists of patients with advanced or metastatic (stage IIIB/IIIC or IV) NSCLC diagnosis between January 1, 2015 and December 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one line of therapy (LOT) for advanced/metastatic disease.

  2. The inclusion criteria for the breast cancer cohort consists of female patients with advanced or metastatic (stage IIIB/IIIC and IV) HER2-negative BC diagnosis between January 1, 2012 and December 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one LOT for advanced/metastatic disease.

Exclusion Criteria

  1. The exclusion criteria for both cohorts consist of patients with other primary cancer type prior to the cohort entry date and patients who are pregnant 9 months (275 days) prior to, on, or after the cohort entry date.

Study Design

Total Participants: 13759
Treatment Group(s): 1
Primary Treatment: No drug
Phase:
Study Start date:
July 09, 2024
Estimated Completion Date:
March 18, 2025

Study 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.

Connect with a study center

  • ConcertAI Database

    Cambridge, Massachusetts 02138
    United States

    Site Not Available

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