{"entity":{"id":"flaura2","kind":"trial","name":"FLAURA2","aka":[],"tldr":"Adding chemotherapy to osimertinib extended both progression-free and, in 2025, overall survival.","summary":"FLAURA2, trial NCT04035486 sponsored by AstraZeneca and published in the New England Journal of Medicine in 2023, showed that adding platinum chemotherapy to first-line osimertinib in EGFR-mutant non-small-cell lung cancer extends progression-free survival and, in 2025, overall survival. It randomised 557 patients to osimertinib with or without chemotherapy and met its primary investigator-assessed progression-free survival endpoint, with the survival benefit reported later. OnCo links it to non-small-cell lung cancer, osimertinib, Suresh S. Ramalingam, Pasi A. Jänne, Guangdong Provincial People's Hospital, FURLONG, the bottleneck of acquired resistance, the idea of alternating schedules and the FLAURA and MARIPOSA papers. The two regimens have never been compared directly, and which patients need intensification is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT04035486","url":"https://clinicaltrials.gov/study/NCT04035486"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["suresh-ramalingam","pasi-janne"],"bottlenecks":[],"keyPapers":["paper-flaura-nejm-2018","paper-mariposa-nejm-2024","paper-flaura2-long-term-safety-lung-cancer-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04035486","phase":"3","setting":"First-line EGFR-mutant NSCLC: osimertinib + chemotherapy vs osimertinib","sponsor":"AstraZeneca","result":"PFS HR 0.62; OS HR 0.77.","started":"2019-07-02","startedType":"actual","yearReported":2023,"enrolled":587,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator)","primary":true,"unit":"months","arms":[{"name":"Osimertinib + chemotherapy","n":279,"value":25.5},{"name":"Osimertinib","n":278,"value":16.7}],"hr":0.62,"ci":[0.49,0.79],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2306434"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Osimertinib + chemotherapy","value":47.5},{"name":"Osimertinib","value":37.6}],"hr":0.77,"ci":[0.61,0.96],"p":"0.02","source":"https://clinicaltrials.gov/study/NCT04035486"}],"replication":"Consistent with MARIPOSA in showing that intensifying first-line therapy beyond osimertinib alone extends survival; the two regimens have not been compared directly."},"route":"/trials/flaura2/","neighbours":{"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"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/"}],"drug":[{"id":"osimertinib","kind":"drug","name":"Osimertinib","route":"/drugs/osimertinib/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"person":[{"id":"pasi-janne","kind":"person","name":"Pasi A. Jänne","route":"/people/pasi-janne/"},{"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/"},{"id":"paper-flaura2-long-term-safety-lung-cancer-2026","kind":"paper","name":"FLAURA2: long-term safety of first-line osimertinib plus platinum-pemetrexed in EGFR-mutated advanced lung cancer","route":"/key-papers/paper-flaura2-long-term-safety-lung-cancer-2026/"},{"id":"paper-mariposa-nejm-2024","kind":"paper","name":"MARIPOSA: amivantamab plus lazertinib versus osimertinib as first treatment for EGFR-mutated lung cancer","route":"/key-papers/paper-mariposa-nejm-2024/"},{"id":"paper-planchard-flaura2-osimertinib-chemotherapy-nejm-2023","kind":"paper","name":"Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC","route":"/key-papers/paper-planchard-flaura2-osimertinib-chemotherapy-nejm-2023/"}],"bottleneck":[{"id":"b-resistance","kind":"bottleneck","name":"Acquired resistance to every therapy","route":"/bottlenecks/b-resistance/"}],"idea":[{"id":"idea-bio1-upfront-bypass-combination","kind":"idea","name":"Add the second drug on day one when the escape route is predictable","route":"/ideas/idea-bio1-upfront-bypass-combination/"},{"id":"idea-moon-closed-loop-adaptive-therapy","kind":"idea","name":"Autonomous closed-loop adaptive therapy driven by blood tests and evolutionary models","route":"/ideas/idea-moon-closed-loop-adaptive-therapy/"},{"id":"idea-tr2-alternating-vs-concurrent","kind":"idea","name":"Test alternating drug schedules against giving both drugs at once","route":"/ideas/idea-tr2-alternating-vs-concurrent/"}],"institution":[{"id":"guangdong-provincial-peoples-hospital","kind":"institution","name":"Guangdong Provincial People's Hospital","route":"/institutions/guangdong-provincial-peoples-hospital/"}],"trial":[{"id":"furlong","kind":"trial","name":"FURLONG","route":"/trials/furlong/"}],"roadmap":[{"id":"targeted-therapy-roadmap","kind":"roadmap","name":"Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall","route":"/roadmaps/targeted-therapy-roadmap/"}]}}