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

NCT05737849 | Withdrawn

• 1 other identifier: TAK-788-4004
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Drug Therapy; EGFR exon20 insertion mutation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (11)

• 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

• Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Demographic Characteristics

  Up to 3 years prior to leading site initiation

• 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

• 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

• Cohort 1 and 2: Site of Metastasis at the Time of NGS Testing

  Up to 3 years prior to leading site initiation

Study Arms (2)

Cohort 1: Participants With Positive EGFR ex20ins Detection

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

Other: No Intervention

Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection

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

Other: No Intervention

Interventions

No Intervention OTHER

As this is an observational study, no intervention will be administered in this study.

Cohort 1: Participants With Positive EGFR ex20ins Detection; Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Cohort 1 and 2:
• \. Participants with a diagnosis of locally advanced or metastatic NSCLC, clinical staging of IIIB-IV.
• Cohort-1:
• \. Participants who have received NGS testing and have EGFR ex20ins positive result.
• Cohort-2:
• \. Participants who have received NGS testing

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (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, 100021, China

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: January 30, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CN (1)