{"entity":{"id":"notable-trial","kind":"trial","name":"NOTABLE (nimotuzumab, KRAS wild-type pancreatic cancer)","aka":[],"tldr":"In the minority of pancreatic cancers without a KRAS mutation, adding the EGFR antibody nimotuzumab to gemcitabine helped people live longer, and China approved it in 2023.","summary":"NOTABLE randomised patients in China with KRAS wild-type locally advanced or metastatic pancreatic cancer to nimotuzumab or placebo with gemcitabine. Overall survival, the primary endpoint, was longer with nimotuzumab, with the benefit concentrated in patients who had not had biliary obstruction. On this trial China's regulator approved nimotuzumab for KRAS wild-type pancreatic cancer in 2023, the first EGFR-directed approval in the disease since erlotinib.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02395016","url":"https://clinicaltrials.gov/study/NCT02395016"},{"label":"Qin et al., Journal of Clinical Oncology 2023: nimotuzumab plus gemcitabine for K-Ras wild-type pancreatic cancer (NOTABLE)","url":"https://doi.org/10.1200/JCO.22.02630"}],"tags":[],"related":[],"cancers":["pancreatic","kras-wild-type-pdac"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["egfr","kras"],"drugs":["nimotuzumab","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-qin-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02395016","phase":"3","setting":"Locally advanced or metastatic KRAS wild-type pancreatic cancer: nimotuzumab plus gemcitabine versus placebo plus gemcitabine","sponsor":"Biotech Pharmaceutical (China)","result":"Overall survival improved with nimotuzumab plus gemcitabine in KRAS wild-type disease.","started":"2015-04","startedType":"actual","yearReported":2023,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nimotuzumab + gemcitabine","n":41,"value":10.9,"note":"Restricted mean survival time 18.05 vs 11.14 months, ratio 0.62 (95% CI 0.40-0.97), p = 0.036; 82 eligible KRAS wild-type patients in the full analysis set"},{"name":"Placebo + gemcitabine","n":41,"value":8.5}],"p":"0.036","source":"https://doi.org/10.1200/JCO.22.02630"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Nimotuzumab + gemcitabine","value":4.2},{"name":"Placebo + gemcitabine","value":3.6}],"hr":0.6,"ci":[0.37,0.99],"p":"0.04","source":"https://doi.org/10.1200/JCO.22.02630"}]},"route":"/trials/notable-trial/","neighbours":{"cancer":[{"id":"kras-wild-type-pdac","kind":"cancer","name":"KRAS wild-type pancreatic ductal adenocarcinoma","route":"/cancers/kras-wild-type-pdac/"},{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"}],"drug":[{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"nimotuzumab","kind":"drug","name":"Nimotuzumab","route":"/drugs/nimotuzumab/"}],"paper":[{"id":"paper-qin-j-clin-oncol","kind":"paper","name":"Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer","route":"/key-papers/paper-qin-j-clin-oncol/"}]}}