This clinical trial studies whether circulating tumor deoxyribonucleic acid (ctDNA) testing can be used to guide the treatment of stage II-II non-small cell lung cancer (NSCLC). Deoxyribonucleic acid (DNA) is the material that carries all the information about how a living thing will work or function. Many types of tumors tend to lose cells or release different types of cellular products including their DNA, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. The ctDNA levels can be drawn after the patient undergoes surgery to remove the tumor (postoperative) to see if any ctDNA remains. The postoperative ctDNA levels can then be used by doctors to help decide whether to start, stop, or change treatment. It can also be used to help doctors decide whether radiation therapy should be used to kill tumor cells that may have been left behind after surgery. This may be an effective way to guide the treatment of stage II-III NSCLC.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06979661.
Locations matching your search criteria
United States
New Jersey
Jersey City
Jersey City Medical CenterStatus: Active
Contact: Arunabh Sekhri
Phone: 201-915-2000
Livingston
Saint Barnabas Medical CenterStatus: Active
Contact: Andrew B. Brown
Phone: 973-322-5200
Long Branch
Monmouth Medical CenterStatus: Active
Contact: Seth D. Cohen
Phone: 732-222-1711
New Brunswick
Rutgers Cancer Institute of New JerseyStatus: Active
Contact: Salma K. Jabbour
Phone: 732-253-3939
Somerville
Robert Wood Johnson University Hospital SomersetStatus: Active
Contact: Joel K. Braver
Phone: 908-927-8702
Toms River
Community Medical CenterStatus: Active
Contact: Seth D. Cohen
Phone: 732-557-8032
PRIMARY OBJECTIVE:
I. Evaluate the role of ctDNA positivity in decision making for postoperative radiation and systemic therapy for non-small cell lung cancer.
SECONDARY OBJECTIVES:
I. Evaluate personalized postoperative chemotherapy (chemo)/immune checkpoint inhibitor (ICPI)/targeted therapies/radiation therapy in clearing ctDNA.
II. Evaluate the disease-free survival (DFS) and overall survival (OS) of stage II/III lung cancer patients with postoperative ctDNA positive status.
EXPLORATORY OBJECTIVE:
I. Evaluate radiomics features based on serial computed tomography (CT) thoracic CT scans to determine if radiomic features can be associated with ctDNA positivity/negativity as well as recurrence patterns.
OUTLINE: Patients undergo postoperative ctDNA testing during screening. Patients with negative postoperative ctDNA status are assigned to arm I and patients with positive postoperative ctDNA status are assigned to arm II.
ARM I: Patients receive standard of care (SOC) treatment with chemotherapy, radiation, and/or other therapies or undergo observation based on multidisciplinary discussions and patient input on study in the absence of disease progression or unacceptably toxicity.
ARM II: Patients undergo thoracic radiation therapy over 25-30 treatment fractions and receive chemotherapy, immune checkpoint inhibitor therapy, and/or targeted therapy at the discretion of the treating physician on study in the absence of disease progression or unacceptable toxicity.
Additionally, all patients undergo CT and blood sample collection on study. Patients may also optionally undergo blood sample collection during screening.
After completion of study treatment, patients are followed up every 4-6 months for 2 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorSalma K. Jabbour
