{"entity":{"id":"navigate","kind":"trial","name":"NAVIGATE","aka":[],"tldr":"The basket trial behind the first tumour-agnostic TRK inhibitor approval: larotrectinib shrank tumours in three of four patients whatever the organ, as long as the cancer carried an NTRK gene fusion.","summary":"NAVIGATE, trial NCT02576431 sponsored by Bayer through Loxo Oncology, enrolled adults and children with TRK fusion-positive solid tumours of any type. Its early results were pooled with the adult phase 1 study and the paediatric SCOUT trial in the New England Journal of Medicine in 2018: 75% of the first 55 patients responded on independent review across 17 tumour types, and most responses were durable. The data supported the 2018 US accelerated approval of larotrectinib, the first treatment approved for a genomic marker regardless of tumour site, and the 2019 EU approval.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT02576431","url":"https://clinicaltrials.gov/study/NCT02576431"},{"label":"Drilon et al., Efficacy of larotrectinib in TRK fusion-positive cancers in adults and children (NEJM 2018)","url":"https://doi.org/10.1056/NEJMoa1714448"}],"tags":[],"related":[],"cancers":["metastatic-cancer","ntrk-fusion-nsclc"],"sections":[],"technologies":["cgp","kinase-inhibitors"],"targets":["ntrk"],"drugs":["larotrectinib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-navigate-j-clin-invest-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02576431","phase":"2","setting":"TRK fusion-positive solid tumours in adults and children, any tumour type: larotrectinib single-arm basket trial","sponsor":"Bayer (Loxo Oncology)","result":"ORR 75% by independent review in the first 55 pooled patients across 17 tumour types.","started":"2015-09-30","startedType":"actual","yearReported":2018,"enrolled":215,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (independent review, pooled with LOXO-TRK-14001 and SCOUT)","primary":true,"unit":"%","arms":[{"name":"Larotrectinib","n":55,"value":75}],"source":"https://doi.org/10.1056/NEJMoa1714448"}]},"route":"/trials/navigate/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"},{"id":"ntrk-fusion-nsclc","kind":"cancer","name":"NTRK fusion-positive non-small-cell lung cancer","route":"/cancers/ntrk-fusion-nsclc/"}],"technology":[{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"ntrk","kind":"target","name":"NTRK","route":"/targets/ntrk/"}],"drug":[{"id":"larotrectinib","kind":"drug","name":"Larotrectinib","route":"/drugs/larotrectinib/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"}],"paper":[{"id":"paper-navigate-j-clin-invest-2021","kind":"paper","name":"NTRK and RET fusion-directed therapy in pediatric thyroid cancer yields a tumor response and radioiodine uptake","route":"/key-papers/paper-navigate-j-clin-invest-2021/"}],"term":[{"id":"basket-trial","kind":"term","name":"Basket trial","route":"/terms/basket-trial/"},{"id":"basket-umbrella-platform","kind":"term","name":"Basket, umbrella, and platform trials","route":"/terms/basket-umbrella-platform/"},{"id":"clinical-equipoise","kind":"term","name":"Clinical equipoise","route":"/terms/clinical-equipoise/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"},{"id":"trial-phases","kind":"term","name":"Phase 1, 2 and 3 trials","route":"/terms/trial-phases/"},{"id":"pivotal-trial","kind":"term","name":"Pivotal (registrational) trial","route":"/terms/pivotal-trial/"},{"id":"single-arm","kind":"term","name":"Single-arm trial","route":"/terms/single-arm/"},{"id":"trial-lifecycle","kind":"term","name":"Trial lifecycle: from protocol to label","route":"/terms/trial-lifecycle/"}]}}