SBRT to the Primary Tumor Followed by Conventional Radiation Therapy and Chemotherapy for Patients with Locally Advanced Non-Small Cell Lung Cancer (NRG-LU008)

June 09 2023

NRG Oncology recently activated the phase III NRG-LU008 clinical trial for patients with locally advanced, inoperable, node-positive non-small cell lung cancer (NSCLC). This trial will be testing 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.

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 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 concurrently with chemotherapy. Both treatment arms will then receive 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 the most common site of thoracic failure among patients treated with this new standard of care. That is why trying to further improve outcomes through the innovated approach for 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, 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 profilesas 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

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

NRG-LU008 Video Interview with Dr. Simone

Dr. Charles Simone discusses the NRG-LU008 study: Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer

Watch the full interview

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