Blood Testing to Detect Cancer Recurrence in Patients With Early-Stage Non-Small Cell Lung Cancer

NCT07854769 | Not Yet Recruiting

• 1 other identifier: TH-252
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non-small cell lung cancer; NSCLC; ctDNA; Circulating tumor DNA; Liquid biopsy

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 36 months after surgery.

Secondary Outcomes (7)

• Recurrence-Free Survival by Postoperative ctDNA Status

  From the four-to-six-week postoperative ctDNA assessment through up to five years after surgery.

• Proportion of Participants With Negative ctDNA Results at Treatment Entry

  At treatment entry: Cycle 1, Day 1 of neoadjuvant therapy or the date of surgery.

• Sensitivity of Postoperative ctDNA for Predicting Three-Year Recurrence

  ctDNA assessed four to six weeks after surgery; recurrence assessed through 36 months after surgery.

• Specificity of Postoperative ctDNA for Predicting Three-Year Recurrence

  ctDNA assessed four to six weeks after surgery; recurrence assessed through 36 months after surgery.

• Positive Predictive Value of Postoperative ctDNA for Three-Year Recurrence

  ctDNA assessed four to six weeks after surgery; recurrence assessed through 36 months after surgery.

Study Arms (1)

Patients With Surgically Resectable Stage IB-IIIA NSCLC

Adults with treatment-naïve, histologically or cytologically confirmed stage IB-IIIA non-small cell lung cancer (AJCC 9th edition) who are considered surgical candidates by their treating physicians. Participants receive standard-of-care treatment, which may include neoadjuvant therapy, surgery, and adjuvant therapy, as clinically indicated. Serial blood samples and tumor tissue are collected for circulating tumor DNA and molecular residual disease analyses, with follow-up for cancer recurrence for up to five years after surgery. The first 50 participants receiving neoadjuvant therapy undergo additional blood, tissue, and stool collection for correlative studies.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Ability to understand and willingness to sign a written informed consent and HIPAA consent document
• Must be willing and able to provide a core tumor biopsy.
• A core tumor biopsy meeting minimum preanalytical requirements is necessary for MRD assay evaluation. The preference is for a sample prior to start of neoadjuvant treatment as roughly 20% of patients will have a complete response and won't have any tumor in the surgical sample. However, if not possible, then sample could come after surgery.
• Patients who go directly to surgery could submit tumor samples after surgery.

You may not qualify if:

• 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.
• Patients who are unable/refuse to participate in blood collection at designated time points.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples and tumor tissue from pretreatment biopsy or surgical resection will be collected for circulating tumor DNA and molecular residual disease analyses. For the first 50 participants receiving neoadjuvant therapy, additional peripheral blood, surgical tumor or tumor-bed tissue, lymph node tissue, and stool samples will be collected for immune profiling, RNA and T-cell receptor sequencing, and microbiome analyses. Retained materials include formalin-fixed paraffin-embedded tissue, frozen tissue, and preserved blood cells.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hossein Borghaei, DO

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hossein Borghaei, DO

CONTACT

215-728-4300; hossein.borghaei@fccc.edu

Henkel Valentine, PhD

CONTACT

267-882-0820; protocoldev@fccc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 6, 2026
• Primary Completion (Estimated): October 5, 2029
• Study Completion (Estimated): October 5, 2031
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share