{"entity":{"id":"intuitt-nf2","kind":"trial","name":"INTUITT-NF2","aka":[],"tldr":"INTUITT-NF2 is a rolling trial for people with the inherited condition NF2, who grow many benign tumours of the nerves and brain lining; its first drug, brigatinib, shrank a share of tumours, slowed the growth of all types and improved hearing in a third of affected ears, which is the evidence behind offering it for these tumours.","summary":"INTUITT-NF2 is an investigator-led adaptive platform trial for adults and adolescents with NF2-related schwannomatosis and progressive target tumours, run from Massachusetts General Hospital with the Children's Tumor Foundation and drug supply from Takeda and Incyte. Sub-studies test one drug at a time against a shared design; brigatinib (a kinase inhibitor identified by preclinical screening) was the first, followed by neratinib and retifanlimab with bevacizumab. The primary endpoint of each sub-study is the radiographic response rate.\n\nIn the brigatinib sub-study 40 patients with 10 vestibular schwannomas, 8 non-vestibular schwannomas, 20 meningiomas and 2 ependymomas as target tumours were treated; 10 percent of target tumours and 23 percent of all tumours responded, annualised growth rates fell for every tumour type, hearing improved in 35 percent of eligible ears and there were no grade 4 or 5 treatment-related events. The corpus's vestibular schwannoma page cites INTUITT-NF2 as the evidence for brigatinib.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04374305","url":"https://clinicaltrials.gov/study/NCT04374305"}],"tags":["soc-trials"],"related":[],"cancers":["vestibular-schwannoma","meningioma","brain-tumours"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["brigatinib","neratinib","retifanlimab","bevacizumab"],"companies":["takeda","incyte"],"institutions":["mgh"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-intuitt-nf2-brigatinib-plotkin-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04374305","phase":"2","setting":"NF2-related schwannomatosis with progressive vestibular or non-vestibular schwannomas, meningiomas or ependymomas: an adaptive platform trial testing targeted drugs in sub-studies (brigatinib, closed; neratinib; retifanlimab with bevacizumab), with radiographic response as the primary endpoint","sponsor":"Scott R. Plotkin, MD, PhD (Massachusetts General Hospital)","result":"Brigatinib produced radiographic responses in 10 percent of target tumours and 23 percent of all tumours, slowed growth of every tumour type and improved hearing in 35 percent of eligible ears in 40 heavily pretreated patients.","yearReported":2024,"enrolled":109,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic response rate, target tumours (brigatinib sub-study)","primary":true,"unit":"%","arms":[{"name":"Brigatinib","n":40,"value":10,"note":"95% CI 3 to 24; median follow-up 10.4 months"}],"source":"https://doi.org/10.1056/NEJMoa2400985"},{"endpoint":"Radiographic response rate, all tumours (brigatinib sub-study)","unit":"%","arms":[{"name":"Brigatinib","n":40,"value":23,"note":"95% CI 16 to 30"}],"source":"https://doi.org/10.1056/NEJMoa2400985"},{"endpoint":"Hearing improvement in eligible ears (brigatinib sub-study)","unit":"%","arms":[{"name":"Brigatinib","value":35,"note":"95% CI 20 to 53"}],"source":"https://doi.org/10.1056/NEJMoa2400985"}]},"route":"/trials/intuitt-nf2/","neighbours":{"cancer":[{"id":"brain-tumours","kind":"cancer","name":"Brain and spinal cord tumours (all types)","route":"/cancers/brain-tumours/"},{"id":"meningioma","kind":"cancer","name":"Meningioma","route":"/cancers/meningioma/"},{"id":"vestibular-schwannoma","kind":"cancer","name":"Vestibular schwannoma (acoustic neuroma)","route":"/cancers/vestibular-schwannoma/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"},{"id":"brigatinib","kind":"drug","name":"Brigatinib","route":"/drugs/brigatinib/"},{"id":"neratinib","kind":"drug","name":"Neratinib","route":"/drugs/neratinib/"},{"id":"retifanlimab","kind":"drug","name":"Retifanlimab","route":"/drugs/retifanlimab/"}],"company":[{"id":"incyte","kind":"company","name":"Incyte","route":"/companies/incyte/"},{"id":"takeda","kind":"company","name":"Takeda","route":"/companies/takeda/"}],"institution":[{"id":"mgh","kind":"institution","name":"Massachusetts General Hospital Cancer Center","route":"/institutions/mgh/"}],"paper":[{"id":"paper-intuitt-nf2-brigatinib-plotkin-nejm-2024","kind":"paper","name":"INTUITT-NF2: brigatinib in NF2-related schwannomatosis with progressive tumours","route":"/key-papers/paper-intuitt-nf2-brigatinib-plotkin-nejm-2024/"}]}}