2024 World Conference on Lung Cancer (WCLC) - Posters-P3.08F.03 NRG LU008: Phase III Randomized Trial of Primary Tumor SBRT Followed by Concurrent Mediastinal Chemoradiation for LA-NSCLC

P3.08F.03 NRG LU008: Phase III Randomized Trial of Primary Tumor SBRT Followed by Concurrent Mediastinal Chemoradiation for LA-NSCLC

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The NRG LU008 is a Phase III randomized trial assessing a novel treatment strategy for patients with locally advanced non-small cell lung cancer (LA-NSCLC) who are inoperable. Conducted by NRG Oncology, the study evaluates the efficacy of stereotactic body radiotherapy (SBRT) combined with chemoradiation. Patients are randomized to either the control arm (standard chemoradiation to all disease sites) or the experimental arm (SBRT to the primary tumor followed by chemoradiation to the nodal disease).<br /><br />The study aims to compare overall survival (OS) and progression-free survival (PFS) between the two groups. Secondary objectives include assessing response rates, local control, patterns of failure, changes in pulmonary function, quality of life, and toxicity. The trial also explores biospecimen analyses and differences in treatment effects between proton and photon radiotherapy.<br /><br />Inclusion criteria for the trial are node-positive stage II-III NSCLC, patients who are medically inoperable or refuse surgery, a primary tumor size of 7 cm, and an ECOG performance status of 0-2. Exclusions include centrally located primary tumors close to involved nodal disease.<br /><br />The trial, which began national patient accrual on May 10, 2023, has recruited 73 patients as of July 31, 2024, with a final target of 474 subjects. The study leverages a hybrid superiority-noninferiority design to establish whether SBRT in combination with chemoradiation can deliver superior or at least non-inferior outcomes compared to traditional treatment methods, with projected improvements in survival and reduced toxicity. <br /><br />Supported by several National Cancer Institute grants, the trial represents a significant effort to improve therapeutic strategies in LA-NSCLC, focusing on innovative radiation techniques to enhance patient outcomes.

Asset Subtitle

John Heinzerling

Meta Tag

Speaker John Heinzerling

Topic Local-Regional NSCLC

Keywords

NRG LU008

Phase III trial

non-small cell lung cancer

stereotactic body radiotherapy

chemoradiation

overall survival

progression-free survival

biospecimen analyses

proton vs photon radiotherapy

National Cancer Institute