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

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Lung; Node; Adenocarcinoma of Lung

Treatments: Diagnostic Test: DetermaRX

Study type: Observational

Funder types: Other

Identifiers

NCT05665504

MCC-21767

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 3 patient groups

High-Risk for Recurrence That Accept Adjuvant Chemotherapy

Description:

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.

Treatment:

Diagnostic Test: DetermaRX

High-Risk for Recurrence That Decline Adjuvant Chemotherapy

Description:

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.

Treatment:

Diagnostic Test: DetermaRX

Low-Risk for Recurrence

Description:

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.

Treatment:

Diagnostic Test: DetermaRX