Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorRutgers, The State University of New Jersey
About 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 does not accept healthy volunteersQualifiers
Have provided signed informed consent for the trial
Aged ≥18 years at the time of informed consent
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Diagnosed with histologically confirmed Stage II-III NSCLC and undergone surgical resection of lung tumor
Disqualifiers
Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent
With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician.
Have known active CNS metastases and/or carcinomatous meningitis.
Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.
Trial design
Design model
Single group
Treatments tested in this trial
Haystack™ ctDNA Assay
Diagnostic testA personalized, tumor-informed circulating tumor DNA (ctDNA) test that analyzes blood samples to detect minimal residual disease (MRD) and guide postoperative treatment decisions for patients with Stage II-III non-small cell lung cancer (NSCLC) following surgical resection. The test results will help determine whether patients should receive postoperative radiation therapy (PORT) and/or systemic therapy adjustments.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Single-Arm - ctDNA-Guided TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Detection of Circulating Tumor DNA (ctDNA) Post-Surgery
This outcome will assess the presence or absence of circulating tumor DNA (ctDNA) in blood samples collected at multiple time points following surgical resection of Stage II-III non-small cell lung cancer (NSCLC). The Haystack™ ctDNA assay will be used to detect minimal residual disease (MRD), and results will be evaluated for their ability to predict recurrence and guide postoperative radiation and systemic therapy decisions.
Time frame
Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgerySecondary outcomes
1
Progression-Free Survival (PFS)
This outcome measures the time from surgery to disease progression or recurrence, as determined by imaging, clinical assessment, or rising ctDNA levels detected via the Haystack™ ctDNA assay.
Time frame
Up to 3 years post-surgery2
Overall Survival (OS)
The time from surgery to death from any cause. This will assess whether ctDNA-guided treatment impacts long-term survival outcomes in patients with Stage II-III NSCLC.
Time frame
Up to 5 years post-surgery3
Change in ctDNA Levels Over Time
Measures the change in ctDNA levels detected in serial blood draws, evaluating whether fluctuations correlate with treatment response, recurrence risk, or progression.
Time frame
Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: