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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05737849
• Other study ID #: TAK-788-4004
• Status: Withdrawn
• Start date: January 30, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Other:
• No Intervention
As this is an observational study, no intervention will be administered in this study.

Locations

Country	Name	City	State
China	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	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 2: Prevalence of EGFR ex20ins in Chinese Participants With Locally Advanced or Metastatic NSCLC	The prevalence of EGFR ex20ins will be reported for participants with locally advanced or metastatic NSCLC.	Up to 3 years prior to leading site initiation
Primary	Cohort 1 and 2: Number of EGFR ex20ins Subtypes in Chinese Participants With Locally Advanced or Metastatic NSCLC	EGFR ex20ins subtype is defined by insertion or duplication mutation occurred in amino acids (AA) 761 to AA775 of EGFR gene. The number of EGFR ex20ins subtypes will be reported.	Up to 3 years prior to leading site initiation
Primary	Cohort 1 and 2: Frequency of Each EGFR ex20ins Subtype in Chinese Participants With Locally Advanced or Metastatic NSCLC	The frequency of each EGFR ex20ins subtype will be reported.	Up to 3 years prior to leading site initiation
Secondary	Cohort 1 and 2: Percentage of Theoretically Underdiagnosed EGFR ex20ins Mutation by Different PCR Kits Based on NGS Real-world Database	The theoretically underdiagnosed rate about EGFR ex20ins detection by different PCR kits available in China will be reported.	Up to 3 years prior to leading site initiation
Secondary	Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Demographic Characteristics	Demographic characteristics include age, gender, smoking history and family history for malignancies.	Up to 3 years prior to leading site initiation
Secondary	Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Clinical Stages of Lung Cancer at the Time of NGS Testing	Number of EGFR ex20ins positive participants with the clinical stages of cancer IIIB, IIIC, IV will be evaluated using the international association for the study of lung cancer eighth edition of the tumor, nodes, and metastases (TNM) classification for staging criteria.	Up to 3 years prior to leading site initiation
Secondary	Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Cytology or Histology at the Time of NGS Testing	Number of EGFR ex20ins positive participants with adenocarcinoma, squamous cell carcinoma, mixed, or other carcinomas will be evaluated.	Up to 3 years prior to leading site initiation
Secondary	Cohort 1 and 2: Site of Metastasis at the Time of NGS Testing	Site of metastasis at the time of NGS testing will be reported.	Up to 3 years prior to leading site initiation
Secondary	Cohort 1 and 2: Number and Kinds of Co-occurring Mutations of EGFR ex20ins at Baseline in Positive Participants Detected by NGS Testing	The number and kinds of co-occurring mutations at baseline will be reported. The baseline is defined as treatment naive before NGS testing.	Baseline (prior to NGS testing)
Secondary	Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Demographic Characteristics	Demographic characteristics include age, gender, smoking history and family history for malignancies.	Up to 3 years prior to leading site initiation
Secondary	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	Number of EGFR ex20ins positive participants, participants with common EGFR mutations and participants with EGFR wild type with the clinical stages of cancer IIIB, IIIC, IV will be evaluated using the international association for the study of lung cancer eighth edition of the TNM classification for staging criteria.	Up to 3 years prior to leading site initiation
Secondary	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	Number of EGFR ex20ins positive participants, participants with common EGFR mutations and participants with EGFR wild type with adenocarcinoma, squamous cell carcinoma, mixed, or other carcinomas will be evaluated.	Up to 3 years prior to leading site initiation
Secondary	Cohort 2: Site of Metastasis at the Time of NGS Testing	Site of metastasis at the time of NGS testing will be reported.	Up to 3 years prior to leading site initiation
Secondary	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	The number and kinds of co-occurring mutations at baseline will be reported. The baseline is defined as treatment naive before NGS testing.	Baseline (prior to NGS testing)

External Links

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