{"entity":{"id":"alter-0303","kind":"trial","name":"ALTER 0303","aka":[],"tldr":"The trial that showed anlotinib helps patients with lung cancer live longer after other treatments have failed, the basis of one of China's most used cancer pills.","summary":"439 patients randomised 2:1. Median overall survival 9.6 versus 6.3 months (hazard ratio 0.68) and progression-free survival 5.4 versus 1.4 months; published in JAMA Oncology 2018. NMPA approval May 2018. Anlotinib went on to approvals in sarcoma, small cell lung cancer and thyroid cancer and to dozens of combination trials with domestic PD-1 antibodies.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT02388919","url":"https://clinicaltrials.gov/study/NCT02388919"},{"label":"JAMA Oncol 2018","url":"https://doi.org/10.1001/jamaoncol.2018.3039"}],"tags":["china"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":[],"drugs":["anlotinib"],"companies":["sino-biopharm"],"institutions":["shanghai-chest-hospital"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-alter-0303-jama-oncol-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02388919","phase":"2/3","setting":"Advanced NSCLC after at least two lines of therapy, China: anlotinib vs placebo","sponsor":"Chia Tai Tianqing (Sino Biopharm)","result":"OS 9.6 vs 6.3 months, HR 0.68.","started":"2015-02-26","startedType":"actual","yearReported":2018,"enrolled":439,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Anlotinib","n":294,"value":9.6},{"name":"Placebo","n":145,"value":6.3}],"hr":0.68,"source":"https://doi.org/10.1001/jamaoncol.2018.3039"}]},"route":"/trials/alter-0303/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"anlotinib","kind":"drug","name":"Anlotinib","route":"/drugs/anlotinib/"}],"company":[{"id":"sino-biopharm","kind":"company","name":"Sino Biopharmaceutical (Chia Tai Tianqing)","route":"/companies/sino-biopharm/"}],"institution":[{"id":"shanghai-chest-hospital","kind":"institution","name":"Shanghai Chest Hospital","route":"/institutions/shanghai-chest-hospital/"}],"paper":[{"id":"paper-alter-0303-jama-oncol-2018","kind":"paper","name":"Effect of Anlotinib as a Third-Line or Further Treatment on Overall Survival of Patients With Advanced Non-Small Cell Lung Cancer: The ALTER 0303 Phase 3 Randomized Clinical Trial","route":"/key-papers/paper-alter-0303-jama-oncol-2018/"}]}}