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Life sciences · Journal article
BMC Cancer · October 23, 2026
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Occurrence of multiple brain metastases is a critical evolution of many cancers with significant neurological and overall survival consequences, despite new-targeted therapy and stereotactic radiotherapy. AGuIX nanoparticles have demonstrated their effectiveness as theranostic and radiosensitizing agents in preclinical studies, and are currently evaluated in ongoing clinical trials. The first-in-human phase 1 NANO-RAD study has demonstrated the good tolerance of intravenous injection of AGuIX up to 100 mg/kg, the dose selected for this study, as well as selective uptake in tumor by MRI. The aim of the NANORAD 2 trial is to assess the efficacy of combining AGuIX with Whole Brain Radiation Therapy (WBRT) versus WBRT alone in the treatment of brain metastases. NANORAD 2 is a multicentric, prospective, randomized, open-label, blinded endpoint phase II clinical trial. Patients with multiple brain metastases from a histologically confirmed solid tumor who could not benefit from stereotactic radiotherapy are eligible for the trial. The randomization procedure by minimization will be carried out centrally, in order to balance potential prognostic factors between the treatment groups. The WBRT prescription dose is 30 Gy in 10 fractions of 3 Gy. The AGuIX arm involves 3 intravenous injections at 100 mg/kg. The primary objective is to determine the best objective intracranial response rate at 6 weeks and 3 months. The study will be adaptive with an interim analysis planned after the enrolment of 20 patients who have received at least one injection or radiotherapy in each arm of treatment (WBRT and AGuIX + WBRT). The persistent role of WBRT in the treatment of multiple brain metastases, and its association with innovative techniques, including hippocampal avoidance, justifies the exploration of agents that increase the efficiency of this treatment. Our study is the first randomized clinical trial using intravenous AGuIX nanoparticle as radiosensitizer. This study will evaluate whether AGuIX increases local control in combination with WBRT. Expected positive clinical outcomes from this study would support the value of AGuIX as a treatment of choice in a subtype of patients with important unmet medical needs. ClinicalTrials.gov: NCT03818386, registered on January 25, 2019. Identifier with the French National Agency for the Safety of Medicines and Health Products (ANSM): N°Eudra CT 2018-001879-20. Protocol: version 9, 10 May 2023.