{"entity":{"id":"flaura","kind":"trial","name":"FLAURA","aka":[],"tldr":"FLAURA showed that starting with the third-generation EGFR drug osimertinib, rather than saving it for later, kept lung cancer under control for almost twice as long and helped people live longer.","summary":"FLAURA randomised 556 patients with untreated advanced non-small-cell lung cancer carrying an EGFR exon 19 deletion or L858R mutation to osimertinib or to a first-generation inhibitor, gefitinib or erlotinib. Osimertinib had been designed to hit the T790M resistance mutation and to spare wild-type EGFR, and the question was whether using it first beat using it after the older drugs failed.\n\nMedian progression-free survival was 18.9 months with osimertinib against 10.2 months with the comparator (hazard ratio 0.46), with fewer brain progressions and less rash and diarrhoea. The final analysis in 2020 showed median overall survival of 38.6 months against 31.8 months (hazard ratio 0.80), even though a third of the comparator arm crossed over to osimertinib.\n\nThe FDA approved osimertinib for first-line use in April 2018 and it became the standard against which FLAURA2 and MARIPOSA were later measured.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02296125","url":"https://clinicaltrials.gov/study/NCT02296125"},{"label":"New England Journal of Medicine 2018","url":"https://doi.org/10.1056/NEJMoa1713137"},{"label":"New England Journal of Medicine 2020 (overall survival)","url":"https://doi.org/10.1056/NEJMoa1913662"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":["osimertinib","gefitinib","erlotinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["egfr-exon19-l858r","tki-term"],"trials":[],"people":["jean-charles-soria","suresh-ramalingam"],"bottlenecks":[],"keyPapers":["paper-flaura-nejm-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02296125","phase":"3","setting":"Untreated advanced non-small-cell lung cancer with an EGFR exon 19 deletion or L858R mutation: osimertinib versus gefitinib or erlotinib","sponsor":"AstraZeneca","result":"Median progression-free survival 18.9 vs 10.2 months (hazard ratio 0.46); median overall survival 38.6 vs 31.8 months (hazard ratio 0.80).","yearReported":2018,"enrolled":556,"outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Osimertinib","n":279,"value":18.9},{"name":"Gefitinib or erlotinib","n":277,"value":10.2}],"hr":0.46,"source":"https://doi.org/10.1056/NEJMoa1713137"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Osimertinib","n":279,"value":38.6},{"name":"Gefitinib or erlotinib","n":277,"value":31.8}],"hr":0.8,"source":"https://doi.org/10.1056/NEJMoa1913662"}],"replication":"FLAURA2 and MARIPOSA both used osimertinib as the control and reproduced its progression-free survival; the Chinese FLAURA China cohort matched the global result."},"route":"/trials/flaura/","neighbours":{"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"drug":[{"id":"erlotinib","kind":"drug","name":"Erlotinib","route":"/drugs/erlotinib/"},{"id":"gefitinib","kind":"drug","name":"Gefitinib","route":"/drugs/gefitinib/"},{"id":"osimertinib","kind":"drug","name":"Osimertinib","route":"/drugs/osimertinib/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"term":[{"id":"egfr-exon19-l858r","kind":"term","name":"EGFR exon 19 deletion & L858R","route":"/terms/egfr-exon19-l858r/"},{"id":"tki-term","kind":"term","name":"Tyrosine kinase inhibitor (TKI)","route":"/terms/tki-term/"}],"person":[{"id":"jean-charles-soria","kind":"person","name":"Jean-Charles Soria","route":"/people/jean-charles-soria/"},{"id":"suresh-ramalingam","kind":"person","name":"Suresh S. Ramalingam","route":"/people/suresh-ramalingam/"}],"paper":[{"id":"paper-flaura-nejm-2018","kind":"paper","name":"FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer","route":"/key-papers/paper-flaura-nejm-2018/"}]}}