{"entity":{"id":"revel","kind":"trial","name":"REVEL","aka":[],"tldr":"Adding an antibody against the VEGF receptor to second-line chemotherapy added about six weeks of life: enough for a licence, not enough for NICE.","summary":"Ramucirumab is a human IgG1 antibody against the extracellular domain of VEGFR-2. REVEL screened 1,825 patients between December 2010 and January 2013 and randomised 1,253 with stage IV squamous or non-squamous disease progressing on or after first-line platinum chemotherapy to docetaxel 75 mg/m2 with ramucirumab 10 mg/kg (628) or with placebo (625), stratified by sex, region, performance status and previous maintenance therapy.\n\nMedian overall survival was 10.5 months against 9.1 months (hazard ratio 0.86, 95 percent confidence interval 0.75 to 0.98, p=0.023) and median progression-free survival 4.5 against 3.0 months (0.76, 0.68 to 0.86). Squamous histology was included, which was unusual for an anti-angiogenic drug after the pulmonary haemorrhage seen with bevacizumab in squamous disease.\n\nThe FDA approved the combination in 2014. NICE TA403 (24 August 2016) does not recommend ramucirumab with docetaxel, so it is not funded in England, and the six-week median gain is why. Ramucirumab reappeared in lung cancer in the Lung-MAP substudy S1800A, where it was combined with pembrolizumab after progression on immunotherapy.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01168973","url":"https://clinicaltrials.gov/study/NCT01168973"},{"label":"REVEL (Lancet 2014)","url":"https://doi.org/10.1016/S0140-6736(14)60845-X"},{"label":"NICE TA403: ramucirumab for previously treated non-small-cell lung cancer (not recommended)","url":"https://www.nice.org.uk/guidance/ta403"}],"tags":[],"related":[],"cancers":["nsclc","lung-squamous-cell-carcinoma","lung-adenocarcinoma"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody","cytotoxic-chemotherapy"],"targets":["vegf"],"drugs":["ramucirumab","docetaxel"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":["lume-lung-1","lung-map-s1800a"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01168973","phase":"3","setting":"Stage IV squamous or non-squamous non-small-cell lung cancer progressing during or after first-line platinum chemotherapy: docetaxel 75 mg/m2 with ramucirumab 10 mg/kg or placebo on day 1 of a 21-day cycle, with overall survival as the primary endpoint","sponsor":"Eli Lilly","result":"Median overall survival 10.5 against 9.1 months (hazard ratio 0.86, p=0.023); progression-free survival 4.5 against 3.0 months.","yearReported":2014,"enrolled":1253,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Ramucirumab with docetaxel","n":628,"value":10.5},{"name":"Placebo with docetaxel","n":625,"value":9.1}],"hr":0.86,"ci":[0.75,0.98],"p":"0.023","source":"https://doi.org/10.1016/S0140-6736(14)60845-X"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Ramucirumab with docetaxel","n":628,"value":4.5},{"name":"Placebo with docetaxel","n":625,"value":3}],"hr":0.76,"ci":[0.68,0.86],"source":"https://doi.org/10.1016/S0140-6736(14)60845-X"}]},"route":"/trials/revel/","neighbours":{"cancer":[{"id":"lung-adenocarcinoma","kind":"cancer","name":"Adenocarcinoma of the lung","route":"/cancers/lung-adenocarcinoma/"},{"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/"},{"id":"lung-squamous-cell-carcinoma","kind":"cancer","name":"Squamous cell carcinoma of the lung","route":"/cancers/lung-squamous-cell-carcinoma/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"drug":[{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"ramucirumab","kind":"drug","name":"Ramucirumab","route":"/drugs/ramucirumab/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}],"trial":[{"id":"lume-lung-1","kind":"trial","name":"LUME-Lung 1","route":"/trials/lume-lung-1/"},{"id":"lung-map-s1800a","kind":"trial","name":"Lung-MAP S1800A: ramucirumab plus pembrolizumab","route":"/trials/lung-map-s1800a/"}]}}