Clinical trial NCT05737849: A Study to Learn About the Tests Looking for a Gene Mutation in Adults With Lung Cancer in China (ELEGANT)
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Drug Therapy
EGFR exon20 insertion mutation
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort 1: Participants with locally advanced or metastatic NSCLC who received NGS testing and have EGFR ex20ins positive results.

Cohort 2: Participants with locally advanced or metastatic NSCLC who received NGS testing.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cohort 2: Prevalence of EGFR ex20ins in Chinese Participants With Locally Advanced or Metastatic NSCLC
timeFrame: Up to 3 years prior to leading site initiation
measure: Cohort 1 and 2: Number of EGFR ex20ins Subtypes in Chinese Participants With Locally Advanced or Metastatic NSCLC
timeFrame: Up to 3 years prior to leading site initiation
measure: Cohort 1 and 2: Frequency of Each EGFR ex20ins Subtype in Chinese Participants With Locally Advanced or Metastatic NSCLC
timeFrame: Up to 3 years prior to leading site initiation
Secondary outcomes:
measure: Cohort 1 and 2: Percentage of Theoretically Underdiagnosed EGFR ex20ins Mutation by Different PCR Kits Based on NGS Real-world Database
timeFrame: Up to 3 years prior to leading site initiation
measure: Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Demographic Characteristics
timeFrame: Up to 3 years prior to leading site initiation
measure: Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Clinical Stages of Lung Cancer at the Time of NGS Testing
timeFrame: Up to 3 years prior to leading site initiation
measure: Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Cytology or Histology at the Time of NGS Testing
timeFrame: Up to 3 years prior to leading site initiation
measure: Cohort 1 and 2: Site of Metastasis at the Time of NGS Testing
timeFrame: Up to 3 years prior to leading site initiation
measure: Cohort 1 and 2: Number and Kinds of Co-occurring Mutations of EGFR ex20ins at Baseline in Positive Participants Detected by NGS Testing
timeFrame: Baseline (prior to NGS testing)
measure: Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Demographic Characteristics
timeFrame: Up to 3 years prior to leading site initiation
measure: Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Clinical Stages of Lung Cancer at the Time of NGS Testing
timeFrame: Up to 3 years prior to leading site initiation
measure: Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Cytology or Histology at the Time of NGS Testing
timeFrame: Up to 3 years prior to leading site initiation
measure: Cohort 2: Site of Metastasis at the Time of NGS Testing
timeFrame: Up to 3 years prior to leading site initiation
measure: Cohort 2: Number and Kinds of Co-occurring Mutations at Baseline in EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type Detected by NGS Testing
timeFrame: Baseline (prior to NGS testing)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: