Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer

Recruiting

• Conditions: Adenocarcinoma of Lung; Lung; Node
• Interventions: Diagnostic Test: DetermaRX

• Registration Number: NCT05665504
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

This study is an observational study of blood and tissue biomarkers. Investigators plan to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Investigators also plan to examine another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer. Finally, investigators plan to determine if one of the blood-based biomarkers can be used to detect any late cancer recurrence.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-27
• Study Start: 2023-01-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2028-02
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer [clinical stage IA-IB (cT1a-T2aN0), <4cm diameter].
• If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center.
• If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center.
• >18 years old, male or female.
• ECOG performance status 0-1.
• Agree to participate in the follow-up protocol.
• Any suspected primary lung cancer cell type (except a suspected typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma).
• Ability to understand and the willingness to sign a written, informed consent document.

Exclusion Criteria

• Participants who are actively receiving any cancer treatment.
• Participants with uncontrolled intercurrent illness.
• Prior lung cancer within 5 years.
• Current active other major cancer except non-melanoma skin cancer.
• Patients with pure ground glass opacities (nodules) or hilar masses.
• Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma).
• Metastatic nodule (suspected) in the lung from an extrapulmonary cancer.
• Patient unable to provide informed consent.
• Prisoner or incarcerated individual.
• For surgical patients, a R1 or R2 resection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low-Risk for Recurrence	DetermaRX	Participants whose gene assay show that they are at a lower risk of recurrence will not be offered additional treatment after resection. Investigators will followup with participants periodically every 6-12 months over 5 years.
High-Risk for Recurrence That Decline Adjuvant Chemotherapy	DetermaRX	Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participant declines, investigators will followup with participants periodically every 6-12 months over 5 years.
High-Risk for Recurrence That Accept Adjuvant Chemotherapy	DetermaRX	Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participants also have a special mutation on the tumor (EGFR), investigators will recommend that the participant also receive the oral anti-EGFR pill (TagrissoTM) daily for 3 years after completing the chemotherapy. The administration of standard postoperative chemotherapy is not considered part of the study. Only the results of the DetermaRx test is a part of this study.

Primary Outcome Measures

Name	Time	Method
Disease Free Survival	Up to 5 years	Disease-free survival (DFS) is defined as the time from surgical resection and adjuvant chemotherapy to recurrence of tumor or death
Overall Survival	Up to 5 Years	Overall survival (OS) is defined as the time (days) from the date of surgical resection and adjuvant chemotherapy to the date of death, due to any reason.

Secondary Outcome Measures

Name	Time	Method
Cancer Recurrence	At 6 Months	Fisher exact test will used to test association of LCDT-1™ blood test with cancer recurrence.
Tumor Malignancy	At 6 Months	Fisher exact test will used to test association of both LCDT1™, NodifyXL2®, and CIZ1b™ blood tests with malignancy.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States