Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy

Early Phase 1

Not yet recruiting

• Conditions: Lung Cancer; Non Small Cell Lung Cancer; Lung Cancer Recurrent

• Registration Number: NCT06979661
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-06-01
• Primary Completion: 2028-06-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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 -

Exclusion Criteria

Exclusion Criteria

1. Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent
2. With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician.
3. Have known active CNS metastases and/or carcinomatous meningitis.
4. Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.
5. Have a history of interstitial lung disease.
6. 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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Rutgers Cancer Institute; 🇺🇸 New Brunswick, New Jersey, United States