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RecruitingNCT06418412Updated Jun 12, 2025

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

An observational study in Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer, sponsored by National Cancer Centre, Singapore. Recruiting at 3 sites in 3 countries. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-06-12.

Sponsored by National Cancer Centre, Singapore · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
600
Ages
21 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • EGFR EXON20 insertion
  • NSCLC (Non small cell lung cancer)
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 600 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

National Cancer Centre, Singapore is the lead sponsor of 116 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with advanced EGFR exon 20 insertion mutated NSCLC.

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

Exclusion Criteria:

  1. Patients without an EGFR exon 20 insertion mutation
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
600 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Overall survival (OS)

    Time from diagnosis to death.

    Time frame: Up to 10 years.

  2. Duration of therapy (DOT)

    Time from start of treatment regimen to end of treatment regimen.

    Time frame: Up to 10 years.

  3. Real-world progression-free survival (PFS)

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

    Time frame: Up to 10 years.

07

Study locations

3 of 3 sites recruiting
  • Seoul National University Hospital
    Seoul, Korea, Republic of
    • Dong-Wan Kim · Contact
    Recruiting
  • National Cancer Centre, Singapore
    Singapore, 168583, Singapore
    Recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    • Jin-Yuan Shih · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06418412
Lead sponsor
National Cancer Centre, Singapore
Responsible party
Sponsor
First posted
May 17, 2024
Start date
Mar 15, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 12, 2025

Study contacts

Cherlyn Shepherdson
Contact
cherlyn.shepherdson@nccs.com.sg
+65 6306 1748
Aaron C. Tan, MBBS, PhD
study chair · National Cancer Centre, Singapore
Daniel SW Tan, BSc, MBBS, PhD
study chair · National Cancer Centre, Singapore
Dong-Wan Kim, MD, MS, PhD
study chair · Seoul National University Hospital
Jin-Yuan Shih, MD, PhD
study chair · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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