Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung CancerNCT06418412
A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated NSCLC
An observational study of Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer, run by National Cancer Centre, Singapore at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer
- How many people
- 600 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Mar 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced EGFR exon 20 insertion mutated NSCLC.
Who may be able to join
- 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
Who cannot join
- 1. Patients without an EGFR exon 20 insertion mutation
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre, Singapore
Singapore, 168583
Aaron C. Tan, MBBS, PhD, +65 6436 8000, aaron.tan@singhealth.com.sg
Daniel SW Tan, BSc, MBBS, PhD, +65 6436 8000, daniel.tan.s.w@singhealth.com.sg
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Dong-Wan Kim
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Jin-Yuan Shih
About this study
Official title: A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated Non-small Cell Lung Cancer (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.
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.
- Keywords
- EGFR EXON20 insertion, NSCLC (Non small cell lung cancer)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Time from diagnosis to death.
Measured: Up to 10 years.
Duration of therapy (DOT)
Time from start of treatment regimen to end of treatment regimen.
Measured: Up to 10 years.
Real-world progression-free survival (PFS)
Time from start of treatment regimen to disease progression or death.
Measured: Up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start15 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron C. Tan, MBBS, PhD, Study chair, National Cancer Centre, SingaporeDaniel SW Tan, BSc, MBBS, PhD, Study chair, National Cancer Centre, SingaporeDong-Wan Kim, MD, MS, PhD, Study chair, Seoul National University HospitalJin-Yuan Shih, MD, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418412
- Sponsor's protocol ID
- ATORG006
- Status last verified
- Jun 2025
- First submitted
- 13 May 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT06418412
- Acronym / sponsor ID
- ATORG006
- Keywords
- EGFR EXON20 insertion, NSCLC (Non small cell lung cancer)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced EGFR exon 20 insertion mutated NSCLC.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Patients without an EGFR exon 20 insertion mutation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer, run by National Cancer Centre, Singapore at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cherlyn Shepherdson (+65 6306 1748, cherlyn.shepherdson@nccs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 10 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.