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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06418412

Enrollment

600

Registered

2024-05-17

Start date

2024-03-15

Completion date

2026-12-31

Last updated

2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer

Keywords

EGFR EXON20 insertion, NSCLC (Non small cell lung cancer)

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 99 Years

Healthy volunteers

Inclusion criteria

1. Histologically confirmed advanced NSCLC 2. Positive testing result from any locally approved test (including but not limited to RT-PCR, Cobas and NGS) for EGFR exon 20 insertion mutation 3. Diagnosis date from 1 Jan 2013 to 31 Dec 2024 (to allow for minimum 12 months of follow-up clinical and treatment outcome data) 4. Male or female adults, age as defined by local regulations

Exclusion criteria

1\. Patients without an EGFR exon 20 insertion mutation

Design outcomes

Primary

Measure	Time frame	Description
Overall survival (OS)	Up to 10 years.	Time from diagnosis to death.
Duration of therapy (DOT)	Up to 10 years.	Time from start of treatment regimen to end of treatment regimen.
Real-world progression-free survival (PFS)	Up to 10 years.	Time from start of treatment regimen to disease progression or death.

Countries

Singapore, South Korea, Taiwan

Contacts

Primary ContactCherlyn Shepherdson

cherlyn.shepherdson@nccs.com.sg+65 6306 1748

Outcome results