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

May 16, 2024 updated by: National Cancer Centre, Singapore

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Dong-Wan Kim
  • Singapore
  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Jin-Yuan Shih

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced EGFR exon 20 insertion mutated NSCLC.

Description

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 2022 (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 10 years.
Time from diagnosis to death.
Up to 10 years.
Duration of therapy (DOT)
Time Frame: Up to 10 years.
Time from start of treatment regimen to end of treatment regimen.
Up to 10 years.
Real-world progression-free survival (PFS)
Time Frame: Up to 10 years.
Time from start of treatment regimen to disease progression or death.
Up to 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Investigators

  • Study Chair: Aaron C. Tan, MBBS, PhD, National Cancer Centre, Singapore
  • Study Chair: Daniel SW Tan, BSc, MBBS, PhD, National Cancer Centre, Singapore
  • Study Chair: Dong-Wan Kim, MD, MS, PhD, Seoul National University Hospital
  • Study Chair: Jin-Yuan Shih, MD, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATORG006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe