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OpenTrials
Completed

NCT Number: NCT06686602

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • 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.

Treatment and study plan

No drug

Other

This is a non-interventional study and no study drug will be administered.

Primary outcomes

  1. Patient Demographics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE

    Time frame: 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)

  2. Clinical Characteristics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.