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  • Cancer Type: Thoracic
  • Study Type: Other
  • NCT#: NCT05665504
  • Phase: Phase II
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  • Overview

    Study Title:

    Phase 2: Using Biomarkers for Diagnosis, Risk Stratification of Post-Treatment Recurrence and Long-Term Surveillance of Lung Cancer


    This study is designed 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 use another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer so that they can be offered additional drug treatment that will improve their chances of long-term cure. Finally, investigators plan to use one of the blood-based biomarkers to detect any late cancer recurrence


    Primary Objectives: 1. Stratify postoperative patients with pathologic lymph node negative non-small cell lung cancers < 5 cm diameter (Stage IA-IIA) for the risk of recurrent cancer using a tumor-tissue based biomarker test and a blood-based biomarker. 2. If the tumor tissue biomarker indicates the tumor is intermediate to high risk for recurrence, patients will be referred to a medical oncologist who will recommend adjuvant chemotherapy. Secondary Objective: 1. Assess the diagnostic accuracy of the two blood-based biomarkers in discriminating between benign and early-stage malignant lung nodules 6-50 mm in diameter and use one of the blood-based biomarker tests to evaluate postoperative early-stage lung cancer patients for recurrent tumor or second primary cancer at their routine 6-monthly surveillance chest CT scan visit.

  • Treatments


    Therapy (NOS)


    AZD9291 (Osimertinib); Osimertinib ()

  • 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), > 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.
    • Participants must have adequate organ and bone marrow function as defined below:
    • a. absolute neutrophil count >1,000/mcL
    • b. platelets >70,000/mcL
    • c. total bilirubin > d. AST(SGOT)/ALT(SGPT) > e. creatinine 3.0 > Agree to participate in the follow-up protocol.
    • Any 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 have had chemotherapy or radiotherapy within 2 years of entering the study.
    • Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1), with the exception of alopecia.
    • Participants who are actively receiving any cancer treatment.
    • History of allergic reactions attributed to adjuvant chemotherapy agents used in study.
    • 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.
    • Pregnant or lactating female.
    • Patient unable to provide informed consent.
    • Prisoner or incarcerated individual.
    • For surgical patients, a R1 or R2 resection.

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