ctDNA Assay for Lung Cancer

(PORT Trial)

Overseen By Salma Jabbour, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Active CNS metastases, Pneumonitis, Interstitial lung disease, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called the Haystack™ ctDNA Assay, a blood test, to help determine the best treatment after lung cancer surgery. It examines whether detecting ctDNA, tiny pieces of cancer DNA in the blood, alters the treatment plan for individuals with non-small cell lung cancer. The trial also evaluates if personalized treatments, such as chemo or radiation, can eliminate ctDNA and improve survival. This study suits those with stage II or III lung cancer who have undergone surgery to remove the tumor and do not have other active cancers. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to benefit from this innovative approach.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Haystack™ ctDNA Assay is safe?

Previous studies have used tests like the Haystack™ ctDNA Assay to help manage solid tumors, including lung cancer. This test detects tiny pieces of cancer DNA in the blood, aiding doctors in determining the best treatment.

Specific safety data for the Haystack™ ctDNA Assay is not available. As the trial is in an early stage, it focuses on understanding how the test can assist in treatment decisions rather than directly treating cancer. Generally, ctDNA tests are considered safe because they are non-invasive, similar to a regular blood test, and do not involve surgery or physical procedures.

While the test guides treatment, it does not treat cancer directly, so it typically does not cause side effects like some cancer treatments. This may make it a well-tolerated option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Haystack™ ctDNA Assay because it offers a novel approach to managing lung cancer treatment. Unlike traditional methods that rely heavily on imaging and biopsies, this assay uses circulating tumor DNA (ctDNA) from a simple blood sample to guide adjuvant treatment decisions. This method could potentially allow for more personalized and timely interventions by detecting cancer-related changes in real time, providing a more dynamic and accurate assessment of how a patient’s cancer is responding to treatment.

What evidence suggests that the Haystack™ ctDNA Assay is effective for guiding postoperative therapy in non-small cell lung cancer?

Research has shown that ctDNA, or circulating tumor DNA, can help predict outcomes for lung cancer patients. The Haystack ctDNA Assay is being evaluated in this trial through a single-arm study to assess its feasibility and impact on guiding adjuvant treatment decisions. This test detects very small amounts of ctDNA, potentially revealing if any cancer cells remain after treatment. Studies have found that ctDNA can guide decisions about additional therapy after surgery, which might improve patient outcomes. In lung cancer, ctDNA levels correlate with patient prognosis after treatment, making it a promising tool for personalized care. Although still under investigation, this test could assist doctors in selecting the best follow-up treatments for patients. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone surgery for non-small cell lung cancer. They must be in the postoperative phase and not yet started any additional therapy. The exact eligibility criteria are not provided, but typically participants should be adults with good organ function and no other serious medical conditions.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I do not have any other active cancers.

Willing and able to comply with all aspects of the protocol

Exclusion Criteria

I have active brain metastases or cancer in the lining of my brain.

I have a history of lung scarring or fibrosis.

Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postoperative Therapy Planning

Postoperative therapy plan is declared after pathology report review and before ctDNA result

Baseline to 2-4 weeks post-surgery

ctDNA Monitoring and Treatment

Participants undergo ctDNA testing to guide adjuvant treatment decisions, including radiation and systemic therapies

12 months

Multiple visits for blood sample collection at baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery

Follow-up

Participants are monitored for disease progression, recurrence, and overall survival

Up to 5 years post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Haystack™ ctDNA Assay

Trial Overview The Haystack™ ctDNA Assay is being tested to see if it can guide decisions about postoperative therapy for lung cancer patients. Researchers want to know if knowing a patient's ctDNA status can change the treatment plan that was set before getting this result.

How Is the Trial Designed?

Group I: Single-Arm - ctDNA-Guided Treatment Experimental Treatment 1 Intervention

This single-group interventional arm evaluates the feasibility and impact of ctDNA testing in guiding adjuvant treatment decisions.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Citations

1. haystackmrd.com haystackmrd.com/

Home - Haystack MRD™ Haystack MRD is a tumor-informed, next-generation MRD test that detects ultralow levels of ctDNA to uncover residual disease in patients with solid tumors.

2. ir.questdiagnostics.com ir.questdiagnostics.com/press-releases/press-release-details/2025/Haystack-Oncology-and-Rutgers-Cancer-Institute-Collaborate-in-a-Clinical-Study-to-Examine-Haystack-MRD-as-a-Guide-for-Post-Surgical-Treatment-for-Lung-Cancer/default.aspx

Haystack Oncology and Rutgers Cancer Institute ... "While existing data supports the prognostic value of ctDNA in lung cancer, this innovative study will now address the question of how ctDNA- ...

3. cancerletter.com cancerletter.com/in-brief/20250926_9i/

Haystack Oncology, Rutgers Cancer Institute to test ... Libtayo (cemiplimab) plus chemotherapy demonstrates a more than double five-year overall survival rate of 19.4%, compared to 8.8% with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12564818/

Circulating Tumor DNA as a Prognostic and Predictive ... This article reviews the current applications of ctDNA in the context of lung cancer, particularly non-small cell lung cancer (NSCLC). Research ...

5. onclive.com onclive.com/view/fda-grants-breakthrough-device-designation-to-haystack-mrd-ctdna-liquid-biopsy-for-stage-ii-crc

FDA Grants Breakthrough Device Designation to Haystack ... The Haystack MRD® test detects minimal residual disease in stage II colorectal cancer using ctDNA, guiding adjuvant therapy decisions post- ...

6. haystackmrd.com haystackmrd.com/faq/

FAQ - Haystack MRD™ Minimal residual disease (MRD) testing identifies the presence of tiny numbers of cancer cells that may remain in the body after treatment.

7. aacrjournals.org aacrjournals.org/clincancerres/article/31/12/2264/762784/Finding-Rearrangements-in-the-Cell-Free-DNA

Finding Rearrangements in the Cell-Free DNA Haystack ctDNA analysis is now a widely used diagnostic approach in the management of patients with solid tumors, including gene fusion–driven lung cancer.

8. clpmag.com clpmag.com/disease-states/cancer/lung-cancer/clinical-study-evaluate-ctdna-test-guiding-lung-cancer-treatment/

Clinical Study to Evaluate ctDNA Test for Guiding Lung ... The study will evaluate the use of ctDNA testing to help optimize postoperative therapy decisions in patients with stage II/III NSCLC.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11333322/

From haystack to high precision: advanced sequencing ... In the present review, we describe different NGS approaches for identifying ctDNA mutation, discussing challenges to standardized methodologies, cost, ...