## Protocol Section
### Identification Module
**NCT ID:** NCT06418412

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** ATORG006
#### Organization
**Class:** OTHER
**Full Name:** National Cancer Centre, Singapore
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Cancer Centre, Singapore

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

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

**Keywords:**

- EGFR EXON20 insertion

- NSCLC (Non small cell lung cancer)

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 600

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Time from diagnosis to death.

**Measure:** Overall survival (OS)

**Time Frame:** Up to 10 years.

**Description:** Time from start of treatment regimen to end of treatment regimen.

**Measure:** Duration of therapy (DOT)

**Time Frame:** Up to 10 years.

**Description:** Time from start of treatment regimen to disease progression or death.

**Measure:** Real-world progression-free survival (PFS)

**Time Frame:** Up to 10 years.

### Eligibility Module

**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 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

**Maximum Age:** 99 Years

**Minimum Age:** 21 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with advanced EGFR exon 20 insertion mutated NSCLC.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** justine.chu.j.h@nccs.com.sg

**Name:** Justine Chu

**Phone:** +65 64368000

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Name:** Dong-Wan Kim

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

**Status:** RECRUITING

**Location 2:**

**City:** Singapore

**Contacts:**

***Contact 1:***

- **Email:** aaron.tan@singhealth.com.sg

- **Name:** Aaron C. Tan, MBBS, PhD

- **Phone:** +65 6436 8000

- **Role:** CONTACT

***Contact 2:***

- **Email:** daniel.tan.s.w@singhealth.com.sg

- **Name:** Daniel SW Tan, BSc, MBBS, PhD

- **Phone:** +65 6436 8000

- **Role:** CONTACT

**Country:** Singapore

**Facility:** National Cancer Centre, Singapore

**Status:** RECRUITING

**Zip:** 168583

**Location 3:**

**City:** Taipei

**Contacts:**

***Contact 1:***

- **Name:** Jin-Yuan Shih

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** National Taiwan University Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** National Cancer Centre, Singapore

**Name:** Aaron C. Tan, MBBS, PhD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** National Cancer Centre, Singapore

**Name:** Daniel SW Tan, BSc, MBBS, PhD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Seoul National University Hospital

**Name:** Dong-Wan Kim, MD, MS, PhD

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** National Taiwan University Hospital

**Name:** Jin-Yuan Shih, MD, PhD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Non-Small Cell Lung Cancer

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Misc Info Module

- Version Holder: 2024-05-31
