A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer. Basic parameters: 21 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore, South Korea, Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated Non-small Cell Lung Cancer (NSCLC)
Overview
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.
Primary outcome measures
- Overall survival (OS) [Time frame: Up to 10 years.]
- Duration of therapy (DOT) [Time frame: Up to 10 years.]
- Real-world progression-free survival (PFS) [Time frame: Up to 10 years.]
Eligibility criteria
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
1\. Patients without an EGFR exon 20 insertion mutation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Singapore · 1 center
- National Cancer Centre, Singapore — Singapore
South Korea · 1 center
- Seoul National University Hospital — Seoul
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT06418412 · ATORG006