{"entity":{"id":"paper-archer-1050-lancet-oncol-2017","kind":"paper","name":"Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial","aka":[],"tldr":"The primary report of ARCHER 1050: dacomitinib held untreated EGFR-mutant lung cancer for a median of 14.7 months against 9.2 months on gefitinib, at the cost of more rash and diarrhoea.","summary":"International, multicentre, randomised, open-label phase 3 trial at 71 academic centres in seven countries or regions in adults with newly diagnosed advanced non-small-cell lung cancer and one EGFR mutation (exon 19 deletion or Leu858Arg). Patients were randomised 1:1 to oral dacomitinib 45 mg a day or gefitinib 250 mg a day, stratified by race and EGFR mutation type. The primary endpoint was progression-free survival by masked independent review in the intention-to-treat population.\n\nBetween May 2013 and March 2015, 452 patients were randomised (227 dacomitinib, 225 gefitinib). Median progression-free survival was 14.7 months (95% CI 11.1 to 16.6) with dacomitinib and 9.2 months (95% CI 9.1 to 11.0) with gefitinib (hazard ratio 0.59, 95% CI 0.47 to 0.74). The most common grade 3 to 4 adverse events on dacomitinib were dermatitis acneiform (14 percent) and diarrhoea (8 percent). Funded by SFJ Pharmaceuticals Group and Pfizer.","asOf":"2026-09-24","links":[{"label":"The Lancet Oncology 2017","url":"https://doi.org/10.1016/S1470-2045(17)30608-3"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/28958502/"},{"label":"ClinicalTrials.gov NCT01774721","url":"https://clinicaltrials.gov/study/NCT01774721"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":["dacomitinib","gefitinib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":["nct01774721"],"people":["wu-yi-long","tony-mok"],"bottlenecks":[],"keyPapers":[],"journals":["lancet-oncology"],"dependsOn":[],"notes":[],"journal":"The Lancet Oncology","year":2017,"doi":"10.1016/S1470-2045(17)30608-3","pmid":"28958502","authors":"Wu YL, Cheng Y, Zhou X, et al.","paperType":"rct","findings":["Median progression-free survival 14.7 vs 9.2 months by masked independent review; hazard ratio 0.59 (95% CI 0.47 to 0.74).","452 patients randomised between May 2013 and March 2015; median follow-up for progression-free survival 22.1 months.","Grade 3 to 4 dermatitis acneiform in 14% and diarrhoea in 8% on dacomitinib."],"whatItMeans":"ARCHER 1050 supported dacomitinib's 2018 US first-line approval and was the first head-to-head win of a second-generation EGFR inhibitor over a first-generation one on progression-free survival. FLAURA, reported the same year, made osimertinib the usual first choice, so dacomitinib is now rarely used.","caveats":["Open-label; patients with brain metastases were excluded, so the result does not speak to the commonest site of EGFR-mutant relapse.","Overall survival was reported separately (Mok 2018).","Dose reductions were needed in two thirds of dacomitinib patients according to the US label."],"changedPractice":true,"participants":452},"route":"/key-papers/paper-archer-1050-lancet-oncol-2017/","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/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"drug":[{"id":"dacomitinib","kind":"drug","name":"Dacomitinib","route":"/drugs/dacomitinib/"},{"id":"gefitinib","kind":"drug","name":"Gefitinib","route":"/drugs/gefitinib/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"trial":[{"id":"nct01774721","kind":"trial","name":"ARCHER 1050","route":"/trials/nct01774721/"}],"person":[{"id":"tony-mok","kind":"person","name":"Tony S. K. Mok","route":"/people/tony-mok/"},{"id":"wu-yi-long","kind":"person","name":"Yi-Long Wu","route":"/people/wu-yi-long/"}],"journal":[{"id":"lancet-oncology","kind":"journal","name":"The Lancet Oncology","route":"/journals/lancet-oncology/"}]}}