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

Takeda

Status: Withdrawn

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05737849

TAK-788-4004

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Cohort 1 and 2:

1. Participants with a diagnosis of locally advanced or metastatic NSCLC, clinical staging of IIIB-IV.

Cohort-1:

1. Participants who have received NGS testing and have EGFR ex20ins positive result.

Cohort-2:

1. Participants who have received NGS testing

Exclusion criteria

1. Incomplete information, including key demographic characteristics, clinicopathological characteristics, and genetic testing information.

Trial design

0 participants in 2 patient groups

Cohort 1: Participants With Positive EGFR ex20ins Detection

Description:

Participants with NSCLC having positive EGFR ex20ins detected by NGS were observed retrospectively for three years prior to leading site initiation.

Treatment:

Other: No Intervention

Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection

Description:

Participants with NSCLC having positive and negative EGFR ex20ins NGS testing results were observed retrospectively for three years prior to leading site initiation.

Treatment:

Other: No Intervention