{"entity":{"id":"nct01774721","kind":"trial","name":"ARCHER 1050","aka":["A7471050","ARCHER1050","ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC","ARCHER 1050"],"tldr":"ARCHER 1050 showed that dacomitinib, a second-generation EGFR pill, kept untreated EGFR-mutant lung cancer under control longer than gefitinib, and a later analysis reported longer survival, though rash and diarrhoea were harsher and patients with brain metastases were excluded.","summary":"ARCHER 1050 was an open-label, randomised phase 3 trial at 71 centres in seven countries or regions that compared dacomitinib with gefitinib in 452 patients with newly diagnosed advanced non-small-cell lung cancer carrying an EGFR exon 19 deletion or L858R mutation. Patients received dacomitinib 45 mg once daily (227) or gefitinib 250 mg once daily (225). Randomisation was stratified by race and EGFR mutation type, patients with brain metastases were excluded, and the primary endpoint was progression-free survival by masked independent review.\n\nMedian progression-free survival was 14.7 months with dacomitinib against 9.2 months with gefitinib (hazard ratio 0.59, 95% CI 0.47 to 0.74; The Lancet Oncology 2017). By independent review 74.9 percent of patients responded on dacomitinib against 71.6 percent on gefitinib, a difference that was not statistically significant, and responses lasted a median of 14.8 against 8.3 months (registry results and US label). A separate mature analysis reported median overall survival of 34.1 months against 26.8 months (hazard ratio 0.76, 95% CI 0.58 to 0.99; Journal of Clinical Oncology 2018). The US label notes that overall survival was not formally tested, because the response rate comparison earlier in the prespecified testing order was not significant. Grade 3 or 4 dermatitis acneiform (14 percent) and diarrhoea (8 percent) were more common on dacomitinib.\n\nThe trial supported the 2018 US first-line approval of dacomitinib. Mok and colleagues described it as the first second-generation EGFR inhibitor to show an overall survival gain over a standard EGFR inhibitor in a phase 3 trial. FLAURA later made osimertinib the usual first-line EGFR inhibitor and displaced dacomitinib.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01774721","url":"https://clinicaltrials.gov/study/NCT01774721"},{"label":"The Lancet Oncology 2017","url":"https://doi.org/10.1016/S1470-2045(17)30608-3"},{"label":"Journal of Clinical Oncology 2018 (overall survival)","url":"https://doi.org/10.1200/JCO.2018.78.7994"},{"label":"Vizimpro label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4ab27d2f-e385-4e9c-b324-fa69c10b855a"},{"label":"ARCHER 1050 (Lancet Oncology 2017)","url":"https://doi.org/10.1016/S1470-2045(17)30608-3"},{"label":"NICE TA595: dacomitinib for untreated EGFR mutation-positive non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta595"}],"tags":[],"related":["flaura"],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":["dacomitinib","gefitinib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["egfr-exon19-l858r","tki-term","brain-metastases"],"trials":["flaura","lux-lung-3"],"people":["wu-yi-long","tony-mok"],"bottlenecks":[],"keyPapers":["paper-archer-1050-lancet-oncol-2017","paper-archer-1050-os-jco-2018"],"journals":[],"dependsOn":[],"notes":["ARCHER 1050 enrolled 452 adults with newly diagnosed advanced non-small-cell lung cancer and a single EGFR mutation (exon 19 deletion or L858R) at 71 centres in seven countries or special administrative regions between May 2013 and March 2015, and randomised them 1:1 to dacomitinib 45 mg daily or gefitinib 250 mg daily in 28-day cycles until progression. Median progression-free survival by masked independent review was 14.7 months (95 percent confidence interval 11.1 to 16.6) against 9.2 months (9.1 to 11.0), hazard ratio 0.59 (0.47 to 0.74). The trial excluded patients with brain metastases, which is the main reason dacomitinib did not displace osimertinib (Lancet Oncology 2017). NICE TA595 (14 August 2019) recommends dacomitinib for untreated EGFR mutation-positive disease in England."],"nct":"NCT01774721","phase":"3","setting":"Untreated advanced non-small-cell lung cancer with an EGFR exon 19 deletion or L858R mutation: dacomitinib versus gefitinib","sponsor":"Pfizer","result":"Median progression-free survival 14.7 vs 9.2 months (hazard ratio 0.59, masked independent review); median overall survival 34.1 vs 26.8 months (hazard ratio 0.76) in a separate mature analysis.","started":"2013-05-09","startedType":"actual","yearReported":2017,"enrolled":452,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (masked independent review)","primary":true,"unit":"months","arms":[{"name":"Dacomitinib","n":227,"value":14.7},{"name":"Gefitinib","n":225,"value":9.2}],"hr":0.59,"ci":[0.47,0.74],"source":"https://doi.org/10.1016/S1470-2045(17)30608-3"},{"endpoint":"Overall survival (mature analysis)","unit":"months","arms":[{"name":"Dacomitinib","n":227,"value":34.1},{"name":"Gefitinib","n":225,"value":26.8}],"hr":0.76,"ci":[0.582,0.993],"p":"0.044","source":"https://doi.org/10.1200/JCO.2018.78.7994"},{"endpoint":"Objective response rate (independent radiologic review)","unit":"%","arms":[{"name":"Dacomitinib","n":227,"value":74.9},{"name":"Gefitinib","n":225,"value":71.6}],"source":"https://clinicaltrials.gov/study/NCT01774721?tab=results"},{"endpoint":"Duration of response (independent radiologic review)","unit":"months","arms":[{"name":"Dacomitinib","value":14.8,"note":"Responders only"},{"name":"Gefitinib","value":8.3,"note":"Responders only"}],"source":"https://clinicaltrials.gov/study/NCT01774721?tab=results"}],"replication":"No other trial compared dacomitinib with gefitinib first line; FLAURA compared osimertinib with gefitinib or erlotinib and became the usual first-line standard."},"route":"/trials/nct01774721/","neighbours":{"trial":[{"id":"flaura","kind":"trial","name":"FLAURA","route":"/trials/flaura/"},{"id":"lux-lung-3","kind":"trial","name":"LUX-Lung 3","route":"/trials/lux-lung-3/"}],"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/"}],"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/"}],"term":[{"id":"brain-metastases","kind":"term","name":"Brain metastases (intracranial disease)","route":"/terms/brain-metastases/"},{"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":"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/"}],"paper":[{"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","route":"/key-papers/paper-archer-1050-lancet-oncol-2017/"},{"id":"paper-archer-1050-os-jco-2018","kind":"paper","name":"Improvement in overall survival in a randomized study that compared dacomitinib with gefitinib in patients with advanced non-small-cell lung cancer and EGFR-activating mutations","route":"/key-papers/paper-archer-1050-os-jco-2018/"}]}}