This observational study will evaluate whether a blood test can detect the return of non-small cell lung cancer at least three months before it is identified on routine imaging. The test measures circulating tumor DNA (ctDNA), which consists of small pieces of DNA released by cancer cells into the blood. Detecting ctDNA after treatment may indicate that cancer cells remain in the body, even when cancer is not visible on scans.
Approximately 200 adults with stage IB-IIIA non-small cell lung cancer who are considered candidates for surgery will participate at Fox Chase Cancer Center. Participants will receive standard-of-care treatment selected by their treating physicians, which may include chemotherapy and immunotherapy before or after surgery. Blood samples will be collected before treatment and at scheduled times during treatment and follow-up. Researchers will compare ctDNA results with routine imaging and clinical outcomes to assess how well the test predicts cancer recurrence.
Participants will be followed for up to five years after surgery, with the primary analysis focused on the first three years. Additional research in a subset of participants will examine blood, tissue, and stool samples to explore relationships among immune responses, gut bacteria, treatment response, and cancer recurrence.
Patients must have histologically or cytologically confirmed stage 1B-3A (AJCC 9th edition) non-small cell lung carcinoma regardless of histology.
Patients must be treatment-naïve.
Patients must be deemed to be surgical candidates as assessed by their treating physician.
Age ≥ 18 years.
Patients with tumors are positive for EGFR exon 19 deletion or L858R mutation or ALK or ROS1 gene fusions are excluded.
Patients who at the discretion of investigators are not suitable for participation.
Patients must not be currently receiving any other investigational agents or immunomodulatory agents with the exception of drugs used for treatment of rheumatoid arthritis or psoriasis
Patients with contraindication to chemotherapy or immunotherapy or refuse these treatments.
Adults aged 18 years or older with treatment-naïve, histologically or cytologically confirmed stage IB-IIIA non-small cell lung cancer (AJCC 9th edition) who are considered candidates for surgical resection by their treating physicians. Approximately 200 participants will be enrolled at Fox Chase Cancer Center. Participants will receive standard-of-care treatment, which may include neoadjuvant therapy, surgery, and adjuvant therapy, as clinically indicated. Enrollment includes surgical candidates regardless of whether neoadjuvant therapy is planned.
Cohort
Prospective
Not listed
Proportion of Participants With ctDNA Detection at Least Three Months Before Clinically Confirmed Recurrence
Proportion of evaluable participants with documented lung cancer recurrence within 36 months after surgery who have a positive circulating tumor DNA (ctDNA) result at least three months before clinically confirmed recurrence. Recurrence is determined using standard-of-care imaging. The primary analysis includes participants with at least three months of follow-up and at least one evaluable ctDNA result obtained at or after the four-to-six-week postoperative assessment.
Recurrence-Free Survival by Postoperative ctDNA Status
Recurrence-free survival is measured from the ctDNA assessment performed four to six weeks after surgery to the first documented recurrence or death from any cause, whichever occurs first. Outcomes will be compared between participants with positive and negative ctDNA results at this postoperative landmark. Participants without an event will be censored at their last disease assessment.
Proportion of Participants With Negative ctDNA Results at Treatment Entry
Proportion of participants with a negative ctDNA result at entry into treatment. Treatment entry is defined as Cycle 1, Day 1 of neoadjuvant therapy for participants receiving neoadjuvant treatment, or the date of surgery for participants proceeding directly to surgical resection.
Sensitivity of Postoperative ctDNA for Predicting Three-Year Recurrence
Proportion of participants who experience clinically confirmed recurrence within three years after surgery who have a positive ctDNA result at the four-to-six-week postoperative landmark assessment. The estimate will be reported with a 95% confidence interval.
Specificity of Postoperative ctDNA for Predicting Three-Year Recurrence
Proportion of participants who do not experience clinically confirmed recurrence within three years after surgery who have a negative ctDNA result at the four-to-six-week postoperative landmark assessment. The estimate will be reported with a 95% confidence interval.
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