# CheckMate 057: nivolumab beats docetaxel after chemotherapy in non-squamous lung cancer

Source: https://onco.cc/key-papers/paper-checkmate-057-nejm-2015/  
OnCo record `paper-checkmate-057-nejm-2015` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

After platinum chemotherapy had failed, the PD-1 antibody nivolumab prolonged life compared with docetaxel in non-squamous lung cancer with far fewer severe side effects, and the benefit was largest in tumours expressing PD-L1.

## Summary

CheckMate 057 randomised 582 patients with non-squamous non-small-cell lung cancer that had progressed during or after platinum-based chemotherapy to nivolumab or docetaxel. Nivolumab improved overall survival, the primary endpoint, with a higher response rate, longer duration of response and a fraction of the severe toxicity of docetaxel. Unlike its squamous counterpart CheckMate 017, the benefit depended on PD-L1 expression, with little difference in PD-L1-negative tumours, which fuelled the debate about PD-L1 as a biomarker.

## Fields

- Kind: Key paper
- Last checked: 2026-09-08
- Journal: New England Journal of Medicine
- Year: 2015
- DOI: 10.1056/NEJMoa1507643
- Authors: Borghaei H, Paz-Ares L, Horn L, et al.
- Findings: 582 patients with previously treated non-squamous NSCLC; nivolumab vs docetaxel.; Median overall survival 12.2 vs 9.4 months, hazard ratio 0.73.; Response rate 19% vs 12%; median duration of response 17.2 vs 5.6 months.; Grade 3 or 4 treatment-related adverse events 10% vs 54%.; Survival benefit increased with PD-L1 expression and was not evident in PD-L1-negative tumours.
- What it means: With CheckMate 017 in squamous disease, this trial ended docetaxel's reign as the default second-line treatment for lung cancer and established PD-1 blockade as standard after chemotherapy. Its PD-L1 finding shaped how later first-line trials were designed and how the biomarker is used in the clinic.
- Caveats: Open-label design.; Early crossing of the survival curves suggested some patients fared worse on nivolumab in the first months.; PD-L1 was assessed retrospectively on archival tissue.

## Sources

- Full text (DOI): https://doi.org/10.1056/NEJMoa1507643
- ClinicalTrials.gov NCT01673867: https://clinicaltrials.gov/study/NCT01673867

## Connected records

- key papers: [CheckMate 017: nivolumab beats docetaxel in squamous lung cancer after chemotherapy](https://onco.cc/key-papers/paper-checkmate-017-nejm-2015/), [KEYNOTE-010 (Herbst 2016): pembrolizumab versus docetaxel in previously treated PD-L1-positive lung cancer](https://onco.cc/key-papers/paper-keynote-010-lancet-2016/), [KEYNOTE-024: pembrolizumab alone beats chemotherapy in PD-L1-high lung cancer](https://onco.cc/key-papers/paper-keynote-024-nejm-2016/)
- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- targets: [PD-1](https://onco.cc/targets/pd1/), [PD-L1](https://onco.cc/targets/pdl1/)
- drugs: [Docetaxel](https://onco.cc/drugs/docetaxel/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- terms: [Objective response rate (ORR)](https://onco.cc/terms/orr/), [Overall survival (OS)](https://onco.cc/terms/os/)
- roadmaps: [Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch](https://onco.cc/roadmaps/lung-cancer-evidence-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/paper-checkmate-057-nejm-2015.json