{"entity":{"id":"lume-meso","kind":"trial","name":"LUME-Meso","aka":[],"tldr":"LUME-Meso randomised 458 patients with epithelioid pleural mesothelioma to first-line cisplatin and pemetrexed with nintedanib or placebo. The phase 2 progression signal for the multi-kinase inhibitor vanished in phase 3, with no delay in progression and no gain in life, a lesson in the unreliability of small phase 2 signals in this disease.","summary":"LUME-Meso, trial NCT01907100 sponsored by Boehringer Ingelheim and reported in 2019, found that the phase 2 progression signal for the multi-kinase inhibitor nintedanib vanished in phase 3. It randomised 458 patients with epithelioid pleural mesothelioma to nintedanib or placebo with first-line cisplatin and pemetrexed and found no difference in progression-free survival and no survival benefit. OnCo links it to mesothelioma, nintedanib and pemetrexed. The record treats it as a lesson in the unreliability of small randomised phase 2 progression signals in mesothelioma, and why such signals so often fail to replicate in this disease is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01907100","url":"https://clinicaltrials.gov/study/NCT01907100"}],"tags":["lesson:phase-2-pfs-signal"],"related":[],"cancers":["mesothelioma"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["nintedanib","pemetrexed"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01907100","phase":"2/3","setting":"Epithelioid pleural mesothelioma, first line: cisplatin-pemetrexed ± nintedanib","sponsor":"Boehringer Ingelheim","participation":[{"nct":"NCT01907100","source":"https://clinicaltrials.gov/study/NCT01907100","fetchedAt":"2026-10-07T16:52:35.670Z","studySha256":"af011e91cc8f23d6724a5ebf44253e67a42b2f9b947b30984f295ebedb746e8f","overallStatus":"TERMINATED","lastUpdatePosted":"2019-03-18","leadSponsor":"Boehringer Ingelheim","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":545,"enrolmentType":"ACTUAL","siteCount":123,"recruitingSiteCount":0,"countries":["Argentina","Australia","Austria","Belgium","Canada","Chile","Croatia","Czechia","Denmark","Egypt","France","Germany","Israel","Italy","Japan","Mexico","Netherlands","Norway","Poland","Portugal","Russia","South Africa","Spain","Sweden","Turkey (Türkiye)","United Kingdom","United States"]}],"result":"PFS HR 1.01, negative.","started":"2013-09-19","startedType":"actual","yearReported":2019,"enrolled":458,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Nintedanib + chemotherapy","n":229,"value":6.8},{"name":"Placebo + chemotherapy","n":229,"value":7}],"hr":1.01,"ci":[0.79,1.3],"source":"https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(19)30139-0/fulltext"}]},"route":"/trials/lume-meso/","neighbours":{"cancer":[{"id":"mesothelioma","kind":"cancer","name":"Mesothelioma","route":"/cancers/mesothelioma/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"nintedanib","kind":"drug","name":"Nintedanib","route":"/drugs/nintedanib/"},{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"}],"company":[{"id":"boehringer-ingelheim","kind":"company","name":"Boehringer Ingelheim","route":"/companies/boehringer-ingelheim/"}]}}