September 14 2020
Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR trial (NCT 04402788)
NRG Oncology activated the NRG-LU007 trial, also known as the RAPTOR trial, in August 2020. This trial will be testing if adding radiation to the immunotherapy drug atezolizumab for patients with extensive stage small cell lung cancer (ES-SCLC) can improve progression-free survival (phase II) and overall survival (phase III) when compared to atezolizumab alone.
“Previous studies for ES-SCLC have indicated a potential benefit from utilizing consolidative radiotherapy during treatment for patients who have not progressed after initial treatment with platinum-containing chemotherapy. By adding radiotherapy to immunotherapy for ES-SCLC patients, our research team hopes to see improvements for local control and systemic control,” stated Quynh-Nhu Nguyen, MD of MD Anderson Cancer Center and the Principal Investigator of NRG-LU007.
The NRG-LU007 trial will occur in two phases. Phase II of this trial will examine approximately 138 patients and Phase III will examine approximately 186 patients. Trial participants will be randomly assigned to receive the usual treatment of atezolizumab alone or the experimental treatment of thoracic and/or extra-thoracic radiotherapy and atezolizumab. The primary objective of NRG-LU007 is to determine investigator-assessed progression-free survival and overall survival. However, researchers will also be exploring: 1) secondary and exploratory objectives for toxicity comparisons between arms; 2) the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumor and greater than 3 visible tumors; 3) the impact of radiotherapy on PFS and OS in patients receiving complete consolidation radiotherapy and patients who received incomplete consolidation; and 4) assessing the association between pre-treatment tumor burden and PFS and OS benefit.
Learn more about this trial on ClinicalTrials.gov
Access the protocol documents and materials on CTSU.org