Clinical trial NCT06418412: A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated NSCLC
Official title: A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated Non-small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer
Keywords: EGFR EXON20 insertion
NSCLC (Non small cell lung cancer)
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced EGFR exon 20 insertion mutated NSCLC.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 10 years.
measure: Duration of therapy (DOT)
timeFrame: Up to 10 years.
measure: Real-world progression-free survival (PFS)
timeFrame: Up to 10 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre, Singapore
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Cancer Centre, Singapore
name: Aaron C. Tan, MBBS, PhD
role: STUDY_CHAIR
affiliation: National Cancer Centre, Singapore
name: Daniel SW Tan, BSc, MBBS, PhD
role: STUDY_CHAIR
affiliation: Seoul National University Hospital
name: Dong-Wan Kim, MD, MS, PhD
role: STUDY_CHAIR
affiliation: National Taiwan University Hospital
name: Jin-Yuan Shih, MD, PhD
role: STUDY_CHAIR
References: