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

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

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; EGFR Gene Mutation
• Intervention / Treatment: Device: Circulating Tumor DNA (ctDNA) Assay

Detailed Description

The goal of this research study is to evaluate the feasibility of a novel EGFR blood plasma ctDNA screening test among East Asian and Latinx participants at risk for lung cancer and ineligible for regular lung cancer screening. The test looks for a gene change called Epidermal Growth Factor Receptor (EGFR), specifically EGFR L858R and exon 19 deletions, which comprise 85-90% of total EGFR mutations. This study seeks to determine if it is possible to use the blood test to detect this type of lung cancer that might not yet show symptoms.

The research study procedures include screening for eligibility, in-clinic visits, blood tests, and an optional questionnaire and/or focus group.

It is expected that about 1000 people will participate in the blood sample collection, 100 individuals in the survey, and 20 individuals in the focus groups.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Lee; Phone Number: 857-215-2795; Email: jennifer_lee2@dfci.harvard.edu
• Study Contact Backup: Name: Fernando Pacheco; Phone Number: 857-215-5686; Email: fernando_pacheco@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Narjust Florez, MD; Phone Number: 617-582-7335; Email: narjust_florez@dfci.harvard.edu
      • Principal Investigator: Narjust Florez, MD
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Daniel Costa, MD, PhD; Phone Number: 617-667-7000; Email: dbcosta@bidmc.harvard.edu
      • Principal Investigator: Daniel Costa, MD, PhD
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Massachusetts General Hospital
      • Contact: Lecia Sequist, MD, MPH; Phone Number: 617-726-5130; Email: lvsequist@mgb.org
      • Principal Investigator: Lecia Sequist, MD, MPH
    • Brighton, Massachusetts, United States, 02135
      • Not yet recruiting
      • Dana-Farber Cancer Institute at Steward St. Elizabeth's
      • Contact: Alys Malcolm, MD; Phone Number: 617-632-4595; Email: alys_malcolm@dfci.harvard.edu
      • Principal Investigator: Alys Malcolm, MD
    • Methuen, Massachusetts, United States, 01844
      • Not yet recruiting
      • Dana-Farber Cancer Instiute Merrimack Valley
      • Principal Investigator: Pedro Sanz-Altamira, MD
      • Contact: Pedro Sanz-Altamira, MD; Phone Number: 978-620-2020; Email: pedro_sanz-altamira@dfci.harvard.edu
    • South Weymouth, Massachusetts, United States, 02190
      • Not yet recruiting
      • Dana-Farber Cancer Institute South Shore
      • Contact: Shail Maingi, MD; Phone Number: 781-624-5000; Email: shail_maingi@dfci.harvard.edu
      • Principal Investigator: Shail Maingi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (Aims 1, 2, and 3) for Group 1 (50 through 80 years of age):

• 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.

Inclusion Criteria (Aims 1, 2, and 3) for Group 2 (40 through 49 years of age):

• 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
• Aim 3: Able to complete and understand the study's informed consent and participate in a focus group in English, Mandarin, Vietnamese, or Spanish.

Exclusion Criteria (Aims 1, 2, and 3) for Groups 1 and 2:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ctDNA Assay; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testing Turnaround Time	The duration from the time of blood draw to the release of the ctDNA testing results to the study team.	Up to 2 years
Recruitment Acceptability	Determining proportion of screened patients who are eligible and who consent to the trial at each collaboration site	Up to 2 years
Barriers to Sample Acquisition	Examining barriers impeding scale-up of sample collection, handling, and delivery	Up to 2 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Massachusetts General Hospital; Beth Israel Deaconess Medical Center; Boston Medical Center
• Investigators: Principal Investigator: Narjust Florez, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Lung Cancer; EGFR Gene Mutation; EGFR-related lung cancer; EGFR positive lung cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Investigative Techniques; Biological Assay
• Other Study ID Numbers: 24-415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes