Maintenance Systemic Therapy plus SBRT for NSCLC

MAINTENANCE SYSTEMIC THERAPY VERSUS CONSOLIDATIVE STEREOTACTIC BODY RADIATION THERAPY (SBRT) PLUS MAINTENANCE SYSTEMIC THERAPY FOR LIMITED METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC): A RANDOMIZED PHASE II/III TRIAL

  • Clinical Trial Information

    Trial Contact: Manchola-Orozco, Carolina; Frankos, Marie

    Trial Phone: 321.841.7293 ; 321.841.7303

  • IRB No: NRG-LU002

    Protocol Abbrev: NRG-LU002

    Principal Investigator: Justin Mathew Rineer, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: NRG-LU002

    Treatment: Docetaxel, Pemetrexed, Gemcitabine, SBRT

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT03137771

  • Objective

    Phase II:
    To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy
    Phase III:
    To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on overall survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy

  • Key Eligibility

    .Pathologic proof of NSCLC with metastases (stage IV disease).
    .Imaging proof of limited metastatic disease and response to therapy/stable disease, by at least CT chest through the adrenals or PET/CT
    .Zubrod Performance Status 0, 1, or 2
    .Adequate organ and hematologic/bone marrow function
    .Patients must have received first-line/induction systemic therapy
    .Patients must have measurable disease at baseline and 3 or fewer discrete, extracranial metastatic disease sites that are technically amenable to SBRT