November 09 2022
Trial in Development Highlight:NRG-LU008 is a protocol that is currently in development at NRG Oncology and expected to open early in 2023. This phase III trial will assess the addition of stereotactic body radiation therapy (SBRT) delivered to the primary lung tumor followed by conventional radiotherapy (RT) and concurrent platinum-based chemotherapy for patients with locally advanced, inoperable, node-positive non-small cell lung cancer (NSCLC).
Patients with stage II or III inoperable, node-positive NSCLC will be enrolled onto the trial and stratified by PD-L1 expression and T-stage. Trial participants will then be randomly assigned to one of two potential treatment arms. Patients on Treatment Arm 1 will receive conventional RT to all sites of known thoracic disease, whereas patients on Treatment Arm 2 will receive SBRT to the primary tumor followed by conventional RT to sites of nodal metastases. Both treatment arms will be delivered with concurrent chemotherapy and followed by up to 12 months of consolidation immunotherapy. The primary aims of this trial are to compare overall survival and progression-free survival between treatment arms.
“While the long-term results of the PACIFIC trial have improved survival outcomes for NSCLC patients whose disease did not progress after platinum-based concurrent chemoradiotherapy, this treatment approach results in only two of five patients alive and only one of three patients disease free at 5 years. Additionally, the primary tumor is a most common site of failure among patients treated with this new standard of care,” stated Charles B. Simone, II, MD, of the New York Proton Center and the Memorial Sloan Kettering Cancer Center, and the Principal Investigator of the NRG-LU008 trial.
“This trial could serve to address an unmet need to improve local control for patients with NSCLC. SBRT will deliver a higher biologically effective dose of irradiation which, if successful, could improve local control, improve survival outcomes, lower toxicities from radiation, and improve quality of life,” added John Heinzerling, MD, of the Levine Cancer Institute and Atrium Health, and the Co-Principal Investigator of NRG-LU008.
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website