{"entity":{"id":"nct01828112","kind":"trial","name":"LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib","aka":[],"tldr":"A phase 3 trial of Ceritinib, Pemetrexed and Docetaxel in Non-small-cell lung cancer, run by Novartis Pharmaceuticals, completed.","summary":"LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib is a phase 3 interventional study registered as NCT01828112 by Novartis Pharmaceuticals, with 231 participants recorded, started 2013-06-28 and reaching its primary completion in 2016-01-26. Interventions recorded: Ceritinib, Pemetrexed, Docetaxel. Conditions recorded: Non-Small Cell Lung Cancer.\n\nLinked to the drug Ceritinib because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01828112","url":"https://clinicaltrials.gov/study/NCT01828112"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ceritinib","pemetrexed","docetaxel"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01828112","phase":"3","setting":"A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib","sponsor":"Novartis Pharmaceuticals","started":"2013-06-28","startedType":"actual","yearReported":2017,"enrolled":231,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC)","primary":true,"unit":"months","arms":[{"name":"Ceritinib","n":115,"value":5.4,"note":"95% CI 4.1 to 6.9; Figures from the ClinicalTrials.gov results section (first posted 2017-07-27), not from a publication"},{"name":"Chemotherapy","n":116,"value":1.6,"note":"95% CI 1.4 to 2.8"}],"hr":0.49,"ci":[0.36,0.67],"p":"<0.001","source":"https://clinicaltrials.gov/study/NCT01828112?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Ceritinib","n":115,"value":17.7,"note":"95% CI 14.2 to 23.7; Figures from the ClinicalTrials.gov results section (first posted 2017-07-27), not from a publication"},{"name":"Chemotherapy","n":116,"value":20.1,"note":"95% CI 11.9 to 31.2"}],"source":"https://clinicaltrials.gov/study/NCT01828112?tab=results"},{"endpoint":"Overall Response Rate (ORR) Per BIRC","unit":"%","arms":[{"name":"Ceritinib","n":115,"value":40.9,"note":"95% CI 31.8 to 50.4; Figures from the ClinicalTrials.gov results section (first posted 2017-07-27), not from a publication"},{"name":"Chemotherapy","n":116,"value":6.9,"note":"95% CI 3.0 to 13.1"}],"source":"https://clinicaltrials.gov/study/NCT01828112?tab=results"}]},"route":"/trials/nct01828112/","neighbours":{"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/"}],"drug":[{"id":"ceritinib","kind":"drug","name":"Ceritinib","route":"/drugs/ceritinib/"},{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}]}}