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

Withdrawn

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Other: No Intervention

• Registration Number: NCT05737849
• Lead Sponsor: Takeda

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.

Study Timeline

• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23
• Study Start: 2024-01-30
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1: Participants With Positive EGFR ex20ins Detection	No Intervention	Participants with NSCLC having positive EGFR ex20ins detected by NGS were observed retrospectively for three years prior to leading site initiation.
Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection	No Intervention	Participants with NSCLC having positive and negative EGFR ex20ins NGS testing results were observed retrospectively for three years prior to leading site initiation.

Primary Outcome Measures

Name	Time	Method
Cohort 2: Prevalence of EGFR ex20ins in Chinese Participants With Locally Advanced or Metastatic NSCLC	Up to 3 years prior to leading site initiation	The prevalence of EGFR ex20ins will be reported for participants with locally advanced or metastatic NSCLC.
Cohort 1 and 2: Number of EGFR ex20ins Subtypes in Chinese Participants With Locally Advanced or Metastatic NSCLC	Up to 3 years prior to leading site initiation	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.
Cohort 1 and 2: Frequency of Each EGFR ex20ins Subtype in Chinese Participants With Locally Advanced or Metastatic NSCLC	Up to 3 years prior to leading site initiation	The frequency of each EGFR ex20ins subtype will be reported.

Secondary Outcome Measures

Name	Time	Method
Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Demographic Characteristics	Up to 3 years prior to leading site initiation	Demographic characteristics include age, gender, smoking history and family history for malignancies.
Cohort 1 and 2: Site of Metastasis at the Time of NGS Testing	Up to 3 years prior to leading site initiation	Site of metastasis at the time of NGS testing will be reported.
Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Cytology or Histology at the Time of NGS Testing	Up to 3 years prior to leading site initiation	Number of EGFR ex20ins positive participants with adenocarcinoma, squamous cell carcinoma, mixed, or other carcinomas will be evaluated.
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	Up to 3 years prior to leading site initiation	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.
Cohort 1 and 2: Percentage of Theoretically Underdiagnosed EGFR ex20ins Mutation by Different PCR Kits Based on NGS Real-world Database	Up to 3 years prior to leading site initiation	The theoretically underdiagnosed rate about EGFR ex20ins detection by different PCR kits available in China will be reported.
Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Demographic Characteristics	Up to 3 years prior to leading site initiation	Demographic characteristics include age, gender, smoking history and family history for malignancies.
Cohort 2: Site of Metastasis at the Time of NGS Testing	Up to 3 years prior to leading site initiation	Site of metastasis at the time of NGS testing will be reported.
Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Clinical Stages of Lung Cancer at the Time of NGS Testing	Up to 3 years prior to leading site initiation	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.
Cohort 1 and 2: Number and Kinds of Co-occurring Mutations of EGFR ex20ins at Baseline in Positive Participants Detected by NGS Testing	Baseline (prior to 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.
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	Baseline (prior to 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.
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	Up to 3 years prior to leading site initiation	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.

Trial Locations

Locations (1)

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, China