{"entity":{"id":"alta","kind":"trial","name":"ALTA","aka":["ALK in Lung Cancer Trial of AP26113","AP26113-13-201"],"tldr":"ALTA tested two doses of brigatinib in ALK-positive lung cancer that had progressed on crizotinib; the higher dose, started after a lower-dose first week, gave more responses and longer control, including in the brain.","summary":"ALTA (ALK in Lung Cancer Trial of AP26113) was a randomised phase 2 trial of brigatinib in ALK-positive non-small-cell lung cancer that had progressed on crizotinib. It randomised 222 patients 1:1 to brigatinib 90 mg once daily (arm A, 112 patients, 109 treated) or 180 mg once daily after a 7-day lead-in at 90 mg (arm B, 110 patients), stratified by brain metastases and best response to crizotinib. At baseline 69 percent had brain metastases and 74 percent had received chemotherapy. The primary endpoint was investigator-assessed confirmed objective response rate; there was no arm without brigatinib.\n\nAt a median follow-up of 8.0 months the confirmed response rate was 45 percent in arm A and 54 percent in arm B, and median progression-free survival was 9.2 and 12.9 months. Among patients with measurable brain metastases, independent review found intracranial responses in 11 of 26 (42 percent) and 12 of 18 (67 percent). Common adverse events were nausea, diarrhoea, headache and cough, mostly grade 1 or 2. A subset of pulmonary adverse events with early onset (median day 2) occurred in 14 of 219 treated patients (grade 3 or higher in 3 percent) and none occurred after escalation to 180 mg in arm B (Journal of Clinical Oncology 2017).\n\nThe authors concluded that 180 mg with the lead-in was consistently more effective than 90 mg with acceptable safety. The trial supported the 2017 US approval of brigatinib after crizotinib; ALTA-1L then tested it against crizotinib in untreated disease.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02094573","url":"https://clinicaltrials.gov/study/NCT02094573"},{"label":"Journal of Clinical Oncology 2017","url":"https://doi.org/10.1200/JCO.2016.71.5904"},{"label":"Journal of Clinical Oncology 2018 (brain metastases, exploratory)","url":"https://doi.org/10.1200/JCO.2017.77.5841"}],"tags":[],"related":["alta-1l"],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["brigatinib"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":["brain-metastases"],"trials":[],"people":["kim-dong-wan","ross-camidge"],"bottlenecks":[],"keyPapers":["paper-alta-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02094573","phase":"2","setting":"ALK-positive advanced non-small-cell lung cancer that progressed on crizotinib: two brigatinib dose regimens, randomised, no control arm","sponsor":"Ariad Pharmaceuticals","result":"Confirmed objective response rate 45% (90 mg) and 54% (180 mg after a 7-day 90 mg lead-in); median progression-free survival 9.2 and 12.9 months (investigator-assessed, 8.0-month median follow-up).","yearReported":2017,"enrolled":222,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed objective response rate (investigator)","primary":true,"unit":"%","arms":[{"name":"Brigatinib 90 mg","n":112,"value":45,"note":"97.5% CI 34 to 56; 112 randomised, 109 treated"},{"name":"Brigatinib 180 mg (7-day 90 mg lead-in)","n":110,"value":54,"note":"97.5% CI 43 to 65"}],"source":"https://doi.org/10.1200/JCO.2016.71.5904"},{"endpoint":"Progression-free survival (investigator)","unit":"months","arms":[{"name":"Brigatinib 90 mg","n":112,"value":9.2},{"name":"Brigatinib 180 mg (7-day 90 mg lead-in)","n":110,"value":12.9}],"source":"https://doi.org/10.1200/JCO.2016.71.5904"},{"endpoint":"Intracranial objective response rate (independent review, measurable brain metastases)","unit":"%","arms":[{"name":"Brigatinib 90 mg","n":26,"value":42,"note":"11 of 26"},{"name":"Brigatinib 180 mg (7-day 90 mg lead-in)","n":18,"value":67,"note":"12 of 18"}],"source":"https://doi.org/10.1200/JCO.2016.71.5904"}]},"route":"/trials/alta/","neighbours":{"trial":[{"id":"alta-1l","kind":"trial","name":"ALTA-1L","route":"/trials/alta-1l/"}],"cancer":[{"id":"alk-positive-nsclc","kind":"cancer","name":"ALK-positive non-small-cell lung cancer","route":"/cancers/alk-positive-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":"alk","kind":"target","name":"ALK","route":"/targets/alk/"}],"drug":[{"id":"brigatinib","kind":"drug","name":"Brigatinib","route":"/drugs/brigatinib/"}],"company":[{"id":"takeda","kind":"company","name":"Takeda","route":"/companies/takeda/"}],"term":[{"id":"brain-metastases","kind":"term","name":"Brain metastases (intracranial disease)","route":"/terms/brain-metastases/"}],"person":[{"id":"ross-camidge","kind":"person","name":"D. Ross Camidge","route":"/people/ross-camidge/"},{"id":"kim-dong-wan","kind":"person","name":"Dong-Wan Kim","route":"/people/kim-dong-wan/"}],"paper":[{"id":"paper-alta-jco-2017","kind":"paper","name":"Brigatinib in patients with crizotinib-refractory ALK-positive non-small-cell lung cancer: a randomized, multicenter phase II trial (ALTA)","route":"/key-papers/paper-alta-jco-2017/"}]}}