Pilot Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT 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.
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Robert Wood Johnson University Hospital, Hamilton
- Robert Wood Johnson University Hospital, Somerset
- Rutgers University
Inclusion Criteria: 1. Have provided signed informed consent for the trial 2. Aged ≥18 years at the time of informed consent 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 4. Diagnosed with histologically confirmed Stage II-III NSCLC and undergone surgical resection of lung tumor 5. No active second cancers/malignancy 6. Patients that received preoperative therapy (including chemotherapy and immunotherapy or others) are eligible 7. Willing and able to comply with all aspects of the protocol 8. Standard of care therapy and methods as per institution and investigator discretion - Exclusion Criteria: Exclusion Criteria 1. Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent 2. With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician. 3. Have known active CNS metastases and/or carcinomatous meningitis. 4. Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis. 5. Have a history of interstitial lung disease. 6. 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. -
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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