November 10 2020
The NRG Oncology phase II/III clinical trial NRG-LU005 is examining the addition of the immunotherapy drug atezolizumab to chemoradiotherapy for patients with limited stage small cell lung cancer (LS-SCLC) to compare this treatment combination to the standard of care treatment of chemoradiotherapy alone. Study researchers want to determine if the addition of immunotherapy helps to improve progression-free survival and overall survival outcomes for this patient population. The trial activated in May 2019 and is currently accruing patients.
“Atezolizumab has previously been approved by the United States Food and Drug Administration (FDA) to treat both the metastatic and extensive forms of small cell lung cancer, but it has yet to be tested in the curative or limited stage lung cancer setting, “ stated Kristin Higgins, MD, of the Winship Cancer Institute at Emory University and the Principal Investigator of NRG-LU005. “Our goal is to increase the 5-year survival of patients with this disease to over 50% from the current 5-year survival rate of approximately 25-30%.”
At this time, patients with LS-SCLC that are treated with the standard of care chemoradiotherapy are typically responsive to the treatment and exhibit signs of decrease in tumor burden; however, many of these patients tend to relapse early and often which ultimately limits long-term survival. NRG-LU005 is testing if using immunotherapy given with chemoradiotherapy could potentially enhance the immune system’s stimulation and decrease the risk of cancer recurrence, thus improving survival outcomes.
“Small cell lung cancer accounts for approximately 15% of lung cancer cases just in the United States and has not seen the same improvements in survival that non-small cell lung cancer has over the past decade. It is imperative to better treatment options to increase survival and decrease these patient’s rate of relapse,” added Higgins.
NRG-LU005 will randomly assign patients to one of two treatment arms. Patients on treatment arm 1 will receive etoposide and cisplatin or carboplatin-based chemotherapy followed by radiation therapy. Patients on treatment arm 2 will receive etoposide and cisplatin or carboplatin-based chemotherapy with radiation therapy and the experimental, immunotherapy drug atezolizumab. Primary endpoints are to determine changes in progression-free survival and overall survival between treatment arms; however, researchers will also be following the incidence of adverse events, objective response rate, local control, distant metastases-free survival, quality of life, quality-adjusted survival, level of fatigue, and blood-based tumor mutational burden between treatments.
More information on this trial can be found on the study’s clinicaltrials.gov page and protocol documents are located on CTSU.org.
Patient information can be found on the study’s patient webpage and in the study’s patient brochure.
Here is a listing of accruing NRG Oncology Lung Cancer trials