The NRG Oncology/Alliance clinical trial NRG-LU005, examining the addition of the immunotherapy drug atezolizumab combined with chemoradiation for patients with limited-stage small cell lung cancer (SCLC) recently reached the trial's accrual goal of 506 patients. Despite this trial closing to patient enrollment in the United States, NRG-LU005 will remain open for accrual to sites based in Japan.
At this time, the United States Food and Drug Administration (FDA) has approved the use of atezolizumab in the treatment of metastatic, extensive stage SCLC, however, NRG-LU005 is the first phase III clinical trial to test atezolizumab in the adjuvant curable stage of SCLC.
There has been an unmet need for new therapies in curable stages of small cell lung cancer for some time. We have conducted NRG-LU005 at a rapid pace, which really reflects the urgency for which new treatments are needed for our patients, and the commitment of our investigators, patients, and their families to be part of potentially practice changing research. We are hopeful that this trial will ultimately lead to more patients being cured of small cell lung cancer."
Kristin Higgins, MD, of Winship Cancer Institute at Emory University and Principal Investigator of the NRG-LU005 trial
Chemotherapy with radiation therapy is the current standard of care for patients with curable limited-stage SCLC which has proven results in decreasing tumor burden, yet patients tend to relapse early and often from this treatment. Adding immunotherapy to the usual treatment could enhance and increase the efficacy of the chemoradiotherapy as well as improve the duration of response and overall survival for patients.
NRG-LU005 randomly assigned patients with limited-stage SCLC to receive chemotherapy (etoposide with cisplatin or carboplatin) and radiation for up to 7 weeks with or without atezolizumab for up to one year. The primary objective of the trial is to compare overall survival between the two treatment regiments. Additionally, secondary objectives include: comparing progression-free survival, overall response rate, rates of local control, distant metastases-free survival, and quality of life between treatments; to characterize immune-mediated and non-immune mediated toxicity and fatigue; and, to evaluate the quality-adjusted survival and the association of blood-based and tissue-based tumor mutation burden. Researchers will also collect biospecimens at varying points before, during, and after treatment for future analysis and will characterize patient-reported symptomatic toxicities. NRG Oncology is grateful to the patients and researchers who are participating in this critical study.
Results from the trial data will be reported as they become available.
"NRG Oncology would like to thank the National Clinical Trials Network sites, research staff, and patients who helped this trial accrue so quickly. The results of this trial could greatly impact and improve outcomes for a larger group of lung cancer patients, and we look forward to the eventual reported data that stems from NRG-LU005," added Quynh-Thu Le, MD, an NRG Oncology Group Chair, the Co-Director of the Radiation Biology Program at the Stanford Cancer Institute, and the Chair of the Department of Radiation Oncology at Stanford University.
NRG-LU005 is sponsored by the National Cancer Institute and led by NRG Oncology with participation of the National Clinical Trials Network. Genentech Inc., a member of the Roche Group, provided atezolizumab through a Cooperative Research and Development Agreement with NCI and supplemental financial support through NRG .