A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated NSCLC

There are limited in depth studies on the epidemiology and clinical management of EGFR exon 20 insertion mutated NSCLC in Asia. In addition, there is preliminary data suggesting the exact location of the insertion and variant may influence the response and efficacy to novel EGFR targeted therapies.

This study aims to fill this knowledge gap, by comprehensively characterising the epidemiology and clinical outcomes of Asian advanced EGFR exon 20 insertion mutated NSCLC patients.

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Key information

Conditions

Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Centre, Singapore, Singapore

About this study

This study will be a multi-center observational study and will enroll patients with advanced EGFR exon 20 insertion mutated NSCLC.

The study will include patients recruited from countries across Asia, including sites in, but not limited to - Hong Kong, Korea, Singapore, Taiwan and Thailand. There will be approximately 20-30 sites recruiting for the study. In Singapore, sites may include National Cancer Centre Singapore (NCCS), National University Hospital (NUH) and Tan Tock Seng Hospital (TTSH).

Approximately 600 patients will be enrolled retrospectively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histologically confirmed advanced NSCLC
Positive testing result from any locally approved test (including but not limited to RT-PCR, Cobas and NGS) for EGFR exon 20 insertion mutation
Diagnosis date from 1 Jan 2013 to 31 Dec 2024 (to allow for minimum 12 months of follow-up clinical and treatment outcome data)
Male or female adults, age as defined by local regulations

Exclusion criteria

Patients without an EGFR exon 20 insertion mutation

Treatment and study plan

Primary outcomes

Overall survival (OS)

Time frame: Up to 10 years.

Time from diagnosis to death.
Duration of therapy (DOT)

Time frame: Up to 10 years.

Time from start of treatment regimen to end of treatment regimen.
Real-world progression-free survival (PFS)

Time frame: Up to 10 years.

Time from start of treatment regimen to disease progression or death.

Study contacts

Contact information is provided by the study sponsor or research team.

Cherlyn Shepherdson

CONTACT

[email protected]

+65 6306 1748

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Registry information

Official study title

A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated Non-small Cell Lung Cancer (NSCLC)

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: May 17, 2024
Registry last updated: Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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