ctDNA Assay for Lung Cancer

(EQUAL Trial)

Recruiting at 6 trial locations

Overseen By Alys Malcolm, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Current cancer, Recent cancer, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new blood test designed to detect early signs of EGFR-positive lung cancer. It targets healthy individuals at risk for lung cancer who cannot undergo regular screening. The test, known as a circulating free DNA (cfDNA) assay, searches for small DNA fragments in the blood that might indicate cancer. This trial suits non-smokers who are East Asian or Hispanic/Latinx and either have a family history of this lung cancer type or have recently experienced certain lung-related symptoms. Participants will provide blood samples and may join surveys or focus groups about their experiences. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to earlier lung cancer detection.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this ctDNA assay is safe for screening lung cancer?

Research shows that the blood test under study, known as a circulating tumor DNA (ctDNA) assay, is generally easy for people to handle. This test involves taking a small blood sample to examine tiny pieces of DNA in the blood. Previous studies have found this method to be a safe and effective way to monitor cancer without harming patients. As it is just a blood test, it carries no major risks or side effects. This type of test is already used in some cancer treatments to help doctors assess disease progression or response to treatment. Overall, the ctDNA test is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard lung cancer screening methods, which typically involve imaging tests like CT scans, the ctDNA assay is a blood test that detects circulating tumor DNA. This approach is less invasive and could potentially catch cancer earlier by identifying genetic changes in the blood before tumors are visible on scans. Researchers are excited about this technique because it offers a non-invasive, quicker way to monitor for lung cancer, which could lead to earlier interventions and better outcomes for patients.

What evidence suggests that this ctDNA assay is effective for screening EGFR positive lung cancer?

Research has shown that a circulating free DNA (cfDNA) assay, or liquid biopsy, could help detect lung cancer early. This trial will use the investigational ctDNA assay to identify changes in tumor DNA in the blood, potentially finding cancer before symptoms appear. In lung cancer cases, this test has effectively detected small amounts of cancer that might remain after treatment. It also enables doctors to quickly identify important signs of lung cancer, allowing for faster customization of treatments. Overall, cfDNA tests are becoming a reliable method for early cancer detection and monitoring. ^{2 6 7 8 9}

Who Is on the Research Team?

Narjust Florez, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for healthy Asian and Latinx individuals at risk of lung cancer who can't have standard screening. It's looking to detect EGFR mutations, which are linked to certain lung cancers.

Inclusion Criteria

I am 40-49 years old and can participate in a study discussion in the specified languages.

I am 40-49, don't use tobacco, and am East Asian or Latinx.

I am 40-49 years old and can understand the study's consent form.

Exclusion Criteria

I am unable to understand or sign the consent form.

I am younger than 40 years old.

I have or had cancer in the last 5 years, excluding certain types.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Blood Sample Collection and Testing

Participants provide blood samples for the ctDNA assay and complete a baseline questionnaire. Positive results are followed by CLIA verification and potentially a lung CT scan.

Up to 2 years

Multiple visits (in-person and virtual)

Follow-up

Participants with positive results are monitored through additional testing and scans. Negative CT scans are followed by a repeat scan in 12 months.

12 months

Follow-up visits as needed

Optional Studies

Participants may participate in optional studies including a one-time survey, virtual focus group, and blood banking study.

What Are the Treatments Tested in This Trial?

Interventions

• Circulating free DNA (cfDNA) Assay

Trial Overview The study tests a new blood test called Circulating Tumor DNA (ctDNA) Assay, designed to screen for EGFR positive lung cancer in people without symptoms.

How Is the Trial Designed?

Group I: ctDNA Assay Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Standardizing the pre-analytical processes for cell-free DNA (cfDNA) testing is crucial for obtaining reliable results, especially due to the low amounts and stability of circulating tumor DNA (ctDNA).

The review provides evidence-based guidelines for pre-analytical procedures specifically for plasma EGFR variant testing, suggesting that these standardized practices can enhance the accuracy and effectiveness of cfDNA testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Practice Guidelines for Pre-Analytical Procedures of Plasma Epidermal Growth Factor Receptor Variant Testing. Shin, S., Woo, HI., Kim, JW., et al.[2022]

Circulating cell-free DNA (cfDNA) testing is a promising minimally invasive method for managing metastatic non-small-cell lung cancer (NSCLC), offering insights into tumor heterogeneity and allowing for repeated assessments over time.

cfDNA testing can be used for various applications, including early diagnosis, monitoring treatment response, and identifying predictive markers, highlighting its potential to enhance patient management in NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of circulating free DNA in the management of NSCLC. Esposito Abate, R., Pasquale, R., Fenizia, F., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12513050/

Predictive Effectiveness of Circulating Tumor DNA in ... These results highlight the potential of ctDNA MRD testing to enhance postoperative surveillance and guide personalized disease management in ...

2. nature.com nature.com/articles/s41698-025-00876-y

Circulating tumor DNA to monitor treatment response in ... In this review, we provide a comprehensive, up-to-date summary of ctDNA in monitoring treatment response with a focus on lung, colorectal, and breast cancers.

3. cell.com cell.com/cell/fulltext/S0092-8674(25)01192-4

Longitudinal ultrasensitive ctDNA monitoring for high ... “Liquid biopsy” of circulating tumor DNA (ctDNA) has emerged as a promising non-invasive approach for detection and risk profiling of malignant ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0169500225004209

ctDNA can detect minimal residual disease in curative ... Detection of circulating tumor DNA (ctDNA) in plasma has been shown across various cancer types to effectively stratify patients into low- and high-risk groups ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2807601

Association of Circulating Tumor DNA Testing Before ... The use of plasma ctDNA testing before tissue diagnosis among patients with suspected advanced lung cancer may expedite biomarker testing and accelerate time ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12189613/

Clinical Utility of ctDNA Analysis in Lung Cancer—A Review This review discusses current and future potential directions for the development and implementation of ctDNA for patients with NSCLC.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0304383523003166

Circulating tumor DNA as liquid biopsy in lung cancer Circulating tumor DNA (ctDNA), an ideal biomarker of liquid biopsy, has emerged as one of the most reliable tools for monitoring tumor processes at molecular ...

8. ascopubs.org ascopubs.org/doi/10.1200/PO.23.00314

Comprehensive Genomic Analysis of Patients With Non ... NGS ctDNA analysis in comprehensive genetic testing improves actionable mutation identification, vital for treating Asian NSCLC cases with high actionable ...

9. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(25)00080-5/fulltext

Reporting of molecular test results from cell-free DNA ... Reporting of molecular test results from cell-free DNA analyses: expert consensus recommendations from the 2023 European Liquid Biopsy Society ctDNA Workshop.