NCT05419700

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

Patient Characteristics, Treatment Patterns and Outcomes of Advanced Non-small Cell Lung Cancer Patients With EGFR Exon 20 Insertion Mutations: A Non-interventional Retrospective Medical Chart Review in Spain

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Timeline

• Start date: 2022-08-05
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-06-15
• Last updated: 2023-09-06

Locations

15 sites across 1 country: Spain