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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-99
SponsorNational Cancer Centre, Singapore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Patients with advanced EGFR exon 20 insertion mutated NSCLC.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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