December 01 2021
The NRG Oncology clinical trial NRG-LU002 comparing local consolidative therapy (LCT) and maintenance systemic therapy to maintenance systemic therapy alone for limited-metastatic non-small cell lung cancer (NSCLC) recently reached the trial’s accrual goal for the Phase 2 portion of the study. The trial is expected to remain closed for required follow-up and protocol-specific analysis of the data from the Phase 2 portion of the study until the second quarter of 2022, when a decision will be made regarding the reopening of the trial for continued accrual to address the Phase 3 research question.
The NRG-LU002 Phase 2 study accrued patients with limited metastatic NSCLC who had completed at least 4 cycles of first-line systemic therapy and had displayed no signs of progression and stratified patients by squamous versus non-squamous disease as well as prior systemic therapy regimen. Patients were randomly assigned to receive either maintenance systemic therapy alone, or LCT consisting of stereotactic body radiation therapy (SBRT) with or without surgery followed by maintenance systemic therapy. The goal of the Phase 2 portion of the trial is to determine whether adding LCT to maintenance systemic therapy shows a signal for improved progression-free survival for patients.
“Although maintenance systemic therapy shows significant improvements in survival outcomes for patients with metastatic NSCLC, improved local control with local therapies has the potential to further stabilize disease and lengthen the lives of patients with limited metastases following initial treatment,” stated Puneeth Iyengar, MD, PhD, the Principal Investigator of the NRG-LU002 study and the Chief of Lung Radiation Oncology Services at UT Southwestern Medical Center.
Should the trial reopen to accrual, the Phase 3 research question will examine whether the addition of LCT to maintenance systemic therapy can improve overall survival outcomes for patients with limited metastatic NSCLC.
“NRG Oncology extends our gratitude to the National Clinical Trials Network sites and research staff who diligently worked, amid a pandemic, to accrue patients to this trial. Reaching this successful milestone for NRG-LU002 is a testament to your dedication to our mission of improving and impacting the lives of those with cancer,” 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.
An email broadcast will be distributed by NRG Oncology when the decision is made regarding the accrual reopening for the Phase 3 research question of NRG-LU002. To be included in the NRG Oncology email broadcast mailing list, please contact NRG-Broadcasts@NRGOncology.org.
About NRG Oncology
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research of the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), Radiation Therapy Oncology Group (RTOG), and Gynecologic Oncology Group (GOG) programs. The research network seeks to carry out clinical trials with emphases on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI), part of the National Institutes of Health, and is one of five research groups in the NCI’s National Clinical Trials Network.