EQUAL: EGFR ctDNA QUantative Assessment for Lung Cancer Screening in Asian and Latinx Populations

NCT06716580 | Recruiting FDA Device

• 1 other identifier: 24-415
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 6

Brief Summary

This research study is studying a new blood test to screen for Epidermal Growth Factor Receptor (EGFR) positive lung cancer in healthy individuals at risk for the disease and who cannot undergo regular lung cancer screening. The name of the test used in this research study is:

• Circulating free DNA (cfDNA) Assay

Conditions

Lung Cancer; EGFR Gene Mutation

Keywords

Lung Cancer; EGFR Gene Mutation; EGFR-related lung cancer; EGFR positive lung cancer

Outcome Measures

Primary Outcomes (1)

• Detection Rate of Non-Small Cell Lung Cancer

  The proportion of participants with a positive assay result who are subsequently diagnosed with lung cancer through clinical pathology, among all participants tested with the assay.

  2 years

Secondary Outcomes (3)

• Testing Turnaround Time

  Up to 2 years

• Recruitment Acceptability

  Up to 2 years

• Barriers to Sample Acquisition

  Up to 2 years

Study Arms (1)

ctDNA Assay

EXPERIMENTAL

All participants will be asked to provide blood samples and are administered a baseline questionnaire. The blood sample will be tested using the investigational ctDNA assay. If the investigational test is positive, these participants will be followed up by CLIA verification of results. A positive CLIA result will be followed up by a lung CT scan. A positive CT scan will be followed up by referral for further evaluation. A negative CT scan will be followed up by a repeat scan in 12 months. Participants will be notified of results. Additionally, participants may participant in optional studies: 1) One-time survey regarding perception of lung cancer screening and ctDNA testing, 2) Virtual focus group, 3) Blood banking study

Device: Circulating Tumor DNA (ctDNA) Assay

Interventions

Circulating Tumor DNA (ctDNA) Assay DEVICE

Screening investigational blood test to test for EGFR L858R and exon 19 deletions, which comprise 85-90% of total EGFR mutations. A positive or indeterminate investigational test will be followed up by CLIA verification of results. A positive or indeterminate CLIA result will be followed up by a lung CT scan. A positive CT scan will be followed up by referral for further evaluation. A negative CT scan will be followed up by a repeat scan in 12 months.

ctDNA Assay

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-tobacco using (currently)
• Self-identify as East Asian (including Southeast Asian) or Hispanic/Latinx.
• East Asian includes those who self-identify as Chinese, Japanese, Korean, Taiwanese, Malaysian
• Southeast Asian includes those who self-identify as Cambodian, Thai, Vietnamese, Filipino
• Latinx includes those who self-identify as a person of Central or South American and the Caribbean including, Cuban, Puerto Rican, and Dominican culture or origin, excluding individuals originating from Spain
• Aims 1 and 2: Able to complete and understand the study's informed consent in English, Mandarin, Cantonese, Japanese, Korean, Vietnamese, Spanish, Portuguese, or Cape Verdean
• Aim 3: Able to complete and understand the study's informed consent and participate in a focus group in English, Mandarin, Vietnamese, or Spanish.
• Non-tobacco using (currently)
• Self-identify as East Asian (including Southeast Asian) or Latinx, if any of the following criteria are met:
• Family history of EGFR positive LC L858R or exon 19
• Personal history of remote cancer that is not LC or other thoracic malignancies, including thymoma, thymic carcinoma, or sarcoma, as long as it was resolved over 5 years ago
• History of TB, asthma requiring daily inhaled corticosteroids or chronic bronchitis
• Symptoms of lung cancer for the past month, including hemoptysis, unexplained weight loss, voice hoarseness, cough or worsening cough, dyspnea or worsening dyspnea
• Excluding individuals who concurrently present with fever, covid/influenza/RSV/adenovirus infection, runny nose, sore throat, productive cough with green or yellow sputum
• Aims 1 and 2: Able to complete and understand the study's informed consent in English, Mandarin, Cantonese, Japanese, Korean, Vietnamese, Spanish, Portuguese, or Cape Verdean

You may not qualify if:

• Having had a chest CT scan in the last 3 years or having an anticipated chest CT scan during the enrollment period.
• Having a current cancer or history of cancer within the last 5 years, excluding localized non-melanoma skin cancer and breast ductal carcinoma in situ.
• More than 400 lifetime cigarettes (i.e., 20 packs) of smoking or tobacco use
• Adults unable to provide informed consent
• Individuals \<40 years of age
• Prisoners
• Pregnant women
• Personal diagnosis of lung cancer
• Not able to be compliant with study requirements

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Beth Israel Deaconess Medical Center: collaborator
• Boston Medical Center: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (6)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute at Steward St. Elizabeth's

Brighton, Massachusetts, 02135, United States

NOT YET RECRUITING

Dana-Farber Cancer Instiute Merrimack Valley

Methuen, Massachusetts, 01844, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute South Shore

South Weymouth, Massachusetts, 02190, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Biological Assay

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Narjust Florez, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Lee

CONTACT

857-215-2795; jennifer_lee2@dfci.harvard.edu

Fernando Pacheco

CONTACT

857-215-5686; fernando_pacheco@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: December 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (6)