{"entity":{"id":"lux-lung-3","kind":"trial","name":"LUX-Lung 3","aka":[],"tldr":"Showed that the second-generation EGFR pill afatinib beats chemotherapy for lung cancers driven by an EGFR mutation, and that the benefit is largest for the two common mutations.","summary":"LUX-Lung 3 screened 1,269 patients and randomised 345 with EGFR-mutant stage IIIB or IV lung adenocarcinoma 2:1 to afatinib 40 mg daily or to cisplatin with pemetrexed for up to six cycles, stratified by mutation type (exon 19 deletion, L858R, or other) and race.\n\nMedian progression-free survival by independent review was 11.1 months with afatinib against 6.9 months with chemotherapy (hazard ratio 0.58, 95 percent confidence interval 0.43 to 0.78, p=0.001). Among the 308 patients with an exon 19 deletion or L858R, it was 13.6 against 6.9 months (hazard ratio 0.47, 0.34 to 0.65, p=0.001). Diarrhoea, rash or acne and stomatitis were the characteristic afatinib toxicities; patient-reported cough, breathlessness and pain were better controlled with afatinib.\n\nAfatinib is a covalent pan-ErbB inhibitor, and the later pooled analysis of LUX-Lung 2, 3 and 6 is the main evidence for treating the uncommon EGFR mutations G719X, L861Q and S768I, for which it holds a distinct FDA indication, granted in 2018, that osimertinib does not.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00949650","url":"https://clinicaltrials.gov/study/NCT00949650"},{"label":"LUX-Lung 3 (Journal of Clinical Oncology 2013)","url":"https://doi.org/10.1200/JCO.2012.44.2806"}],"tags":[],"related":[],"cancers":["egfr-mutant-nsclc","lung-adenocarcinoma"],"sections":[],"technologies":["kinase-inhibitors","cytotoxic-chemotherapy","platinum"],"targets":["egfr"],"drugs":["afatinib","cisplatin","pemetrexed"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":["egfr-exon19-l858r","egfr-mutation-subtypes","tki-term"],"trials":["flaura"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00949650","phase":"3","setting":"Untreated stage IIIB or IV lung adenocarcinoma with an EGFR mutation: afatinib 40 mg daily versus up to six cycles of cisplatin with pemetrexed, with progression-free survival by independent review as the primary endpoint","sponsor":"Boehringer Ingelheim","result":"Median progression-free survival 11.1 against 6.9 months (hazard ratio 0.58); 13.6 against 6.9 months in exon 19 deletion or L858R disease.","yearReported":2013,"enrolled":345,"enrolledBasis":"randomised","enrolledNote":"1,269 patients were screened for EGFR mutations and 345 mutation-positive patients were randomised; the registry figure counts the randomised population.","outcomes":[{"endpoint":"Progression-free survival (independent review)","primary":true,"unit":"months","arms":[{"name":"Afatinib","value":11.1},{"name":"Cisplatin and pemetrexed","value":6.9}],"hr":0.58,"ci":[0.43,0.78],"p":"0.001","source":"https://doi.org/10.1200/JCO.2012.44.2806"},{"endpoint":"Progression-free survival, exon 19 deletion or L858R","unit":"months","arms":[{"name":"Afatinib","value":13.6},{"name":"Cisplatin and pemetrexed","value":6.9}],"hr":0.47,"ci":[0.34,0.65],"p":"0.001","source":"https://doi.org/10.1200/JCO.2012.44.2806"}],"replication":"LUX-Lung 6 reproduced the result in an Asian population with gemcitabine and cisplatin as the comparator; FLAURA later made osimertinib the first-line standard for the common mutations."},"route":"/trials/lux-lung-3/","neighbours":{"cancer":[{"id":"lung-adenocarcinoma","kind":"cancer","name":"Adenocarcinoma of the lung","route":"/cancers/lung-adenocarcinoma/"},{"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/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"},{"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":"afatinib","kind":"drug","name":"Afatinib","route":"/drugs/afatinib/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"}],"company":[{"id":"boehringer-ingelheim","kind":"company","name":"Boehringer Ingelheim","route":"/companies/boehringer-ingelheim/"}],"term":[{"id":"egfr-exon19-l858r","kind":"term","name":"EGFR exon 19 deletion & L858R","route":"/terms/egfr-exon19-l858r/"},{"id":"egfr-mutation-subtypes","kind":"term","name":"EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M)","route":"/terms/egfr-mutation-subtypes/"},{"id":"tki-term","kind":"term","name":"Tyrosine kinase inhibitor (TKI)","route":"/terms/tki-term/"}],"trial":[{"id":"nct01774721","kind":"trial","name":"ARCHER 1050","route":"/trials/nct01774721/"},{"id":"flaura","kind":"trial","name":"FLAURA","route":"/trials/flaura/"}]}}