November 12 2024
NRG-LU008 is a phase III clinical trial for patients with locally advanced, inoperable, node-positive non-small cell lung cancer (NSCLC). This trial tests 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 this patient population.
The study is enrolling patients with stage II or III inoperable, node-positive NSCLC, stratified by PD-L1 expression and T-stage. Trial participants are randomly assigned to one of two treatment arms. Patients on Treatment Arm 1 will receive conventional RT to all known sites of thoracic disease concurrently with chemotherapy, whereas patients on Treatment Arm 2 will receive SBRT to the primary tumor followed by conventional RT to sites of nodal metastases, also concurrently with chemotherapy. Both treatment arms will then receive up to 12 months of consolidation immunotherapy or targeted therapy, when appropriate. The primary aims of this trial are to compare overall survival and progression-free survival between the two treatment arms.
“While the long-term results of the PACIFIC trial have improved survival outcomes for patients with NSCLC whose disease did not progress after platinum-based concurrent chemoradiotherapy, this treatment approach results in only two of every five patients alive and only one of three patients disease free at 5 years. Additionally, the primary tumor is the most common site of thoracic failure among patients treated with this new standard of care. That is why trying to improve outcomes through the innovative approach of treatment in NRG-LU008 is so important,” 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.
“NRG-LU008 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 could improve local control, improve survival outcomes, lower toxicities from radiation therapy, 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.
In addition to overall survival and progression-free survival, NRG-LU008 will be examining objective response rate, local control, patterns of failure, changes in pulmonary function, changes in quality of life and patient-reported outcomes, and acute and late toxicity profiles as secondary objectives. Exploratory objectives include the collection of biospecimens for future analysis, calculating regional lung ventilation and dose thresholds associated with pulmonary toxicities, and characterizing differences in outcomes and toxicities between proton and photon radiotherapy.
More Study Information
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website
NRG-LU008 has a patient-facing study webpage available as well on the NRG website at http://www.nrgoncology.org/LU008.
Watch our interview with Dr. Simone about the NRG-LU008 Study: Watch the full interview