February 17 2020
NRG-LU006
*Currently Enrolling Patients*
Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment for Stage I-IIIA Malignant Pleural Mesothelioma
NRG-LU006: Phase III Randomized Trial of Pleurectomy/Decortication plus Chemotherapy with or without Adjuvant Hemithoracic Intensity-Modulated Pleural Radiation Therapy [IMPRINT] for Malignant Pleural Mesothelioma [MPM] opened to enrollment on January 29, 2020.
This trial builds on previously presented and published data showing the feasibility of multimodality treatment, the potential benefit of a trimodality approach, and the feasibility of adjuvant hemithoracic intensity-modulated pleural radiotherapy (IMPRINT) following pleurectomy/decortication.
NRG-LU006 will enroll patients who have malignant pleural mesothelioma (MPM). Patients who participate in NRG-LU006 will all undergo pleurectomy/decortication and receive pemetrexed and cisplatin or carboplatin chemotherapy. Patients on the experimental arm of this trial will receive IMPRINT using photons or proton therapy. The primary objective of the trial will be to detect an improvement in overall survival with the addition of adjuvant IMPRINT to surgery and chemotherapy when compared to surgery and chemotherapy alone.
“If NRG-LU006 demonstrates a survival benefit and acceptable side effects with the addition of IMPRINT, this lung-sparing trimodality approach would constitute a new standard of care for resectable early-stage malignant pleural mesothelioma,” stated Andreas Rimner, MD, of Memorial Sloan Kettering Cancer Center and Principal Investigator of NRG-LU006.
NRG looks forward to institutions opening and enrolling to the study.
More information:
ClinicalTrials.gov: NCT04158141
Protocol documents on CTSU:
NRG-LU006