{"entity":{"id":"checkmate-227","kind":"trial","name":"CheckMate 227","aka":[],"tldr":"CheckMate 227 showed that a chemotherapy-free pair of immunotherapy drugs, nivolumab and ipilimumab, helped people with advanced lung cancer live longer than chemotherapy alone, which made it a first-line option for tumours with any PD-L1 expression.","summary":"CheckMate 227 was a large open-label phase 3 programme in previously untreated advanced non-small-cell lung cancer without EGFR or ALK alterations. Part 1 randomised patients by PD-L1 status to nivolumab plus low-dose ipilimumab, nivolumab alone or nivolumab plus chemotherapy (PD-L1 of 1 percent or more), or to nivolumab plus ipilimumab or nivolumab plus chemotherapy (PD-L1 below 1 percent), each against platinum doublet chemotherapy. The co-primary endpoints were progression-free survival in tumours with high mutational burden and overall survival in PD-L1-positive tumours.\n\nNivolumab plus ipilimumab lengthened overall survival compared with chemotherapy in patients whose tumours expressed PD-L1 at 1 percent or more, and the benefit also appeared in the PD-L1-negative group. The tumour mutational burden endpoint did not translate into an overall survival difference. The combination was approved in the United States in May 2020 for PD-L1-positive disease, and the long-term follow-up has shown a tail of durable survivors in both PD-L1 groups.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02477826","url":"https://clinicaltrials.gov/study/NCT02477826"}],"tags":["subtype-trials"],"related":[],"cancers":["pdl1-high-nsclc","nsclc","lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["matthew-hellmann"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02477826","phase":"3","setting":"Untreated stage IV or recurrent non-small-cell lung cancer without EGFR or ALK alterations: nivolumab plus ipilimumab, nivolumab plus chemotherapy or nivolumab alone against platinum chemotherapy, analysed by PD-L1 expression","sponsor":"Bristol Myers Squibb","result":"Nivolumab plus ipilimumab improved overall survival over chemotherapy in PD-L1-positive advanced non-small-cell lung cancer; approved in the United States in May 2020.","yearReported":2019,"enrolled":2747,"outcomes":[]},"route":"/trials/checkmate-227/","neighbours":{"cancer":[{"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":"pdl1-high-nsclc","kind":"cancer","name":"PD-L1-high non-small-cell lung cancer without a driver mutation","route":"/cancers/pdl1-high-nsclc/"}],"drug":[{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"person":[{"id":"matthew-hellmann","kind":"person","name":"Matthew D. Hellmann","route":"/people/matthew-hellmann/"}]}}