Lung CancerEQUALNCT06716580
EQUAL: EGFR ctDNA QUantative Assessment for Lung Cancer Screening in Asian and Latinx Populations
A study testing Circulating Tumor DNA (ctDNA) Assay in people with Lung Cancer and EGFR Gene Mutation, run by Dana-Farber Cancer Institute at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, EGFR Gene Mutation
- What is being tested?
- Circulating Tumor DNA (ctDNA) Assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Apr 2025to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- Pregnant women
- Personal diagnosis of lung cancer
- Not able to be compliant with study requirements
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Daniel Costa, MD, PhD, 617-667-7000, dbcosta@bidmc.harvard.edu
Daniel Costa, MD, PhD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Narjust Florez, MD, 617-582-7335, narjust_florez@dfci.harvard.edu
Narjust Florez, MD
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02215
Lecia Sequist, MD, MPH, 617-726-5130, lvsequist@mgb.org
Lecia Sequist, MD, MPH
- Not yet recruiting
Dana-Farber Cancer Institute at Steward St. Elizabeth's
Brighton, Massachusetts, 02135
Alys Malcolm, MD, 617-632-4595, alys_malcolm@dfci.harvard.edu
Alys Malcolm, MD
- Not yet recruiting
Dana-Farber Cancer Instiute Merrimack Valley
Methuen, Massachusetts, 01844
Pedro Sanz-Altamira, MD, 978-620-2020, pedro_sanz-altamira@dfci.harvard.edu
Pedro Sanz-Altamira, MD
- Not yet recruiting
Dana-Farber Cancer Institute South Shore
South Weymouth, Massachusetts, 02190
Shail Maingi, MD, 781-624-5000, shail_maingi@dfci.harvard.edu
Shail Maingi, MD
About this study
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
Read the 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.
- Conditions
- Lung Cancer, EGFR Gene Mutation
- Being tested
- Circulating Tumor DNA (ctDNA) Assay
- Keywords
- Lung Cancer, EGFR Gene Mutation, EGFR-related lung cancer, EGFR positive lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating Tumor DNA (ctDNA) AssayDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Circulating Tumor DNA (ctDNA) Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
Testing Turnaround Time
The duration from the time of blood draw to the release of the ctDNA testing results to the study team.
Measured: Up to 2 years
Recruitment Acceptability
Determining proportion of screened patients who are eligible and who consent to the trial at each collaboration site
Measured: Up to 2 years
Barriers to Sample Acquisition
Examining barriers impeding scale-up of sample collection, handling, and delivery
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Apr 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Boston Medical Center, Massachusetts General Hospital
- Responsible party
- Principal investigator, Narjust Florez, Dana-Farber Cancer Institute
- Investigators
- Narjust Florez, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716580
- Sponsor's protocol ID
- 24-415
- Acronym
- EQUAL
- Status last verified
- Jul 2026
- First submitted
- 29 Nov 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EQUAL: EGFR ctDNA QUantative Assessment for Lung Cancer Screening in Asian and Latinx Populations
- ClinicalTrials.gov ID
- NCT06716580
- Acronym / sponsor ID
- EQUAL / 24-415
- Conditions
- Lung Cancer, EGFR Gene Mutation
- Keywords
- Lung Cancer, EGFR Gene Mutation, EGFR-related lung cancer, EGFR positive lung cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Boston Medical Center, Massachusetts General Hospital
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ctDNA Assay | Experimental | Device: Circulating Tumor DNA (ctDNA) AssayAll 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating Tumor DNA (ctDNA) AssayScreening 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. | Device | ctDNA Assay |
Primary outcome
Detection Rate of Non-Small Cell Lung Cancer
Time frame: 2 years
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.
3 secondary outcomes
Testing Turnaround Time
Time frame: Up to 2 years
Recruitment Acceptability
Time frame: Up to 2 years
Barriers to Sample Acquisition
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Narjust Florez, MD principal investigator
Dana-Farber Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circulating Tumor DNA (ctDNA) Assay in people with Lung Cancer and EGFR Gene Mutation, run by Dana-Farber Cancer Institute at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando Pacheco (857-215-2794, fernando_pacheco@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection Rate of Non-Small Cell Lung Cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.