Lung Cancer, Lung Cancer Recurrent, Non Small Cell Lung Cancer
Conditions
Brief summary
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.
Detailed description
This is a pilot, single-arm interventional study evaluating the use of the Haystack™ circulating tumor DNA (ctDNA) assay to guide postoperative radiation therapy (PORT) and systemic therapy decisions for patients with Stage II-III non-small cell lung cancer (NSCLC) who have undergone surgical resection. The study aims to assess whether ctDNA monitoring can effectively detect minimal residual disease (MRD) and improve post-surgical treatment strategies.
Interventions
DIAGNOSTIC_TESTHaystack™ ctDNA Assay
A 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.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Circulating Tumor DNA (ctDNA) Post-Surgery | Baseline, 2-4 weeks, 3 months, 6 months, and 12 months 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 3 years post-surgery | 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. |
| Overall Survival (OS) | Up to 5 years post-surgery | 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. |
| Change in ctDNA Levels Over Time | Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery | Measures the change in ctDNA levels detected in serial blood draws, evaluating whether fluctuations correlate with treatment response, recurrence risk, or progression. |
Countries
United States
Contacts
Primary ContactSalma Jabbour, MD
Outcome results
None listed