{"entity":{"id":"telimet-nsclc-01","kind":"trial","name":"TeliMET NSCLC-01","aka":[],"tldr":"The confirmatory trial for the first c-MET ADC, which was approved early on response rate alone.","summary":"TeliMET NSCLC-01, trial NCT04928846 sponsored by AbbVie, is the randomised phase 3 confirmatory trial for telisotuzumab vedotin, the first c-MET antibody-drug conjugate, which received accelerated approval in May 2025 on response rate alone. It compares telisotuzumab vedotin with docetaxel in previously treated c-Met-overexpressing, EGFR-wild-type non-squamous non-small-cell lung cancer and plans to enrol 768 patients, with enrolment ongoing and no results available. The accelerated approval rested on the single-arm LUMINOSITY study, in which about a third of patients with high c-Met expression responded, and OnCo links the trial to MET as a target. Whether a response-rate approval converts into a survival advantage over chemotherapy is exactly what this trial exists to answer. Telisotuzumab vedotin has its own page.","status":"recruiting","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04928846","url":"https://clinicaltrials.gov/study/NCT04928846"}],"tags":[],"related":[],"cancers":["nsclc","met-altered-nsclc"],"sections":[],"technologies":["adc"],"targets":["met"],"drugs":["telisotuzumab-vedotin"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04928846","phase":"3","setting":"Previously treated c-Met-overexpressing, EGFR-wild-type non-squamous NSCLC: telisotuzumab vedotin vs docetaxel","sponsor":"AbbVie","started":"2022-03-25","startedType":"actual","enrolled":768,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing confirmatory trial for the LUMINOSITY-based accelerated approval."},"route":"/trials/telimet-nsclc-01/","neighbours":{"cancer":[{"id":"met-altered-nsclc","kind":"cancer","name":"MET exon 14 and MET-amplified non-small-cell lung cancer","route":"/cancers/met-altered-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"met","kind":"target","name":"MET","route":"/targets/met/"}],"drug":[{"id":"telisotuzumab-vedotin","kind":"drug","name":"Telisotuzumab vedotin","route":"/drugs/telisotuzumab-vedotin/"}],"company":[{"id":"abbvie","kind":"company","name":"AbbVie (incl. ImmunoGen, Capstan)","route":"/companies/abbvie/"}],"roadmap":[{"id":"targeted-therapy-roadmap","kind":"roadmap","name":"Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall","route":"/roadmaps/targeted-therapy-roadmap/"}]}}