Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy

NCT06979661 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 032411
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Non Small Cell Lung Cancer; Lung Cancer Recurrent

Outcome Measures

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.

  Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  Up to 3 years post-surgery

• Overall Survival (OS)

  Up to 5 years post-surgery

• Change in ctDNA Levels Over Time

  Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery

Study Arms (1)

Single-Arm - ctDNA-Guided Treatment

EXPERIMENTAL

This single-group interventional arm evaluates the feasibility and impact of ctDNA testing in guiding adjuvant treatment decisions.

Diagnostic Test: Haystack™ ctDNA Assay

Interventions

Haystack™ ctDNA Assay DIAGNOSTIC_TEST

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.

Single-Arm - ctDNA-Guided Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No active second cancers/malignancy
• Patients that received preoperative therapy (including chemotherapy and immunotherapy or others) are eligible
• Willing and able to comply with all aspects of the protocol
• Standard of care therapy and methods as per institution and investigator discretion -

You may not qualify if:

• 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.
• Have a history of interstitial lung disease.
• 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. -

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Salma Jabbour, MD

CONTACT

732-235-2465; jabbousk@cinj.rugers.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)