NCT05737849

A Study to Learn About the Tests Looking for a Gene Mutation in Adults With Lung Cancer in China (ELEGANT)

To Investigate EGFR Exon20 Insertion Mutation Testing Methodologies, Clinicopathological Characteristics and Molecular Epidemiology in Chinese Patients With Advanced NSCLC: a Nationwide Multicentre Real-world Registry Study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to examine the percentage of people with lung cancer who carry a certain gene mutation (epidermal growth factor receptor exon 20 insertions - EGFR ex20ins) and their frequency in Chinese participants with Non-small cell lung cancer (NSCLC) after having been tested for the gene mutation. Data from the participant's electronic medical records at the hospital will be collected.

Detailed description

This is a non-interventional, retrospective, observational study of the Chinese participants with locally advanced or metastatic NSCLC with EGFR ex20ins mutation. The primary objective of this study is to explore the prevalence of EGFR ex20ins, subtypes of EGFR ex20ins and their frequency in Chinese participants with locally advanced or metastatic NSCLC. The study will enroll approximately 10800 patients. Participants will be enrolled in the following two cohorts: * Cohort 1: Participants With Positive EGFR ex20ins Detection * Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection The data will be collected retrospectively using the participant electronic medical records and next-generation gene sequencing (NGS)/polymerase chain reaction (PCR) kit instructions. This multi-center trial will be conducted at 15 sites across China. The overall time to participate and data collection will be approximately 12 months.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
OTHER	No Intervention	As this is an observational study, no intervention will be administered in this study.

Timeline

• Start date: 2024-01-30
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2023-02-21
• Last updated: 2023-10-23

Locations

1 site across 1 country: China