# CheckMate 227

Source: https://onco.cc/trials/checkmate-227/  
OnCo record `checkmate-227` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

Nivolumab 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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: 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
- Enrolled: 2747
- 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.

## Sources

- ClinicalTrials.gov NCT02477826: https://clinicaltrials.gov/study/NCT02477826

## Connected records

- cancers: [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [PD-L1-high non-small-cell lung cancer without a driver mutation](https://onco.cc/cancers/pdl1-high-nsclc/)
- drugs: [Ipilimumab](https://onco.cc/drugs/ipilimumab/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- people: [Matthew D. Hellmann](https://onco.cc/people/matthew-hellmann/)

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