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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

Primary Objective: Evaluate the role of ctDNA positivity in decision making for postoperative therapy for non-small cell lung cancer. The plan for postoperative therapy will be declared after pathology report review and before the ctDNA result. We will assess if ctDNA result changed the planned therapy. Secondary Objectives: Evaluate personalized postoperative Chemo/ICPI/Targeted Therapies/Radiation Therapy in clearing ctDNA Evaluate the disease-free survival (DFS) and overall survival (OS) of stage II/III lung cancer patients with postoperative ctDNA positive status Exploratory Objective: Evaluate radiomics features based on serial CT thoracic CT scans to determine if radiomic features can be associated with ctDNA positivity/negativity.

Eligibility Criteria

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.

I have received treatment before surgery, including chemotherapy or immunotherapy.

Exclusion Criteria

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

I have a history of lung scarring or fibrosis.

I have had pneumonitis treated with steroids or have it now.

Timeline

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

Treatment Details

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.

Participant Groups

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+