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

Daiichi Sankyo

Status: Completed

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

Treatments: Other: No drug

Study type: Observational

Funder types: Industry

Identifiers

NCT06686602

DS1062-0008-NIS-EPI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13,759 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

13,759 participants in 2 patient groups

NSCLC

Description:

Adult patients diagnosed with advanced or metastatic (stage IIIB/IIIC or IV) non-small cell lung cancer (NSCLC).

Treatment:

Other: No drug

HER2-negative Breast Cancer

Description:

Adult patients diagnosed with advanced or metastatic (stage IIIB/IIIC or IV) human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Treatment:

Other: No drug