A Spanish Medical Record Review of Clinical Characteristics and Outcomes in Non-small Cell Lung Cancer Participants With EGFR Exon 20 Insertion (ermEX-20)

Takeda

Status: Completed

Conditions: Non-small Cell Lung Cancer (NSCLC)

Study type: Observational

Funder types: Industry

Identifiers

NCT05419700

TAK-788-5009

Details and patient eligibility

About

The main aim is to evaluate sociodemographic and clinical characteristics of advanced Non-Small Cell Lung Cancer (NSCLC) in adults participants with epidermal growth factor receptor (EGFR) exon 20 insertions mutations during the 5 years before data extraction date (from 1-Jan-2017 to 1-Jan-2022).

Participants will not receive any drug. This study will only collect the data from the medical records via chart review.

Full description

This is an observational, non-interventional, retrospective study in participants with NSCLC with EGFR exon 20 insertions mutations. This study will assess the sociodemographic and clinical characteristics of advanced NSCLC participants.

The study will enroll approximately 60 participants. Participants who were evaluated and treated at the participating sites between 01 January 2017 and 30 September 2021 will be included. The data will be collected from the medical record of participants via medical chart review. All the participants will be assigned to a single observational cohort:

• Participants With Advanced NSCLC with EGFR Exon 20 Insertions Mutations

This multi-center trial will be conducted in Spain. The overall duration of the study will be approximately 27 months.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with a pathologically and/or cytologically confirmed diagnosis of advanced stage NSCLC (International Classification of Disease, 10th revision [ICD-10] C34.x), either primary, advanced or after relapse of initial non-metastatic disease, evaluated and treated during the last five years prior data extraction date from 1-Jan-2017 to 1-Jan-2022.
2. Participants with detection of an EGFR exon 20 insertion mutation, at any point.
3. Has documentation available for at least 2 visits since the initiation of the last treatment within the last five years (1-January-2017 to 1-January-2022).

Exclusion criteria

1. Participants do not meet any of the inclusion criteria.

Trial design

76 participants in 1 patient group

Participants with Advanced NSCLC With EGFR Exon 20 Insertions Mutations

Description:

All participants diagnosed with advanced NSCLC with Epidermal growth factor receptor EGFR exon 20 insertion mutations will be enrolled in this study. All study data will be collected retrospectively from participants medical records via medical chart review.