# CheckMate 017: nivolumab beats docetaxel in squamous lung cancer after chemotherapy

Source: https://onco.cc/key-papers/paper-checkmate-017-nejm-2015/  
OnCo record `paper-checkmate-017-nejm-2015` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In squamous non-small-cell lung cancer that had progressed after platinum chemotherapy, the PD-1 antibody nivolumab prolonged life compared with docetaxel with far fewer severe side effects, regardless of PD-L1 status.

## Summary

CheckMate 017 randomised 272 patients with advanced squamous non-small-cell lung cancer that had progressed during or after first-line platinum chemotherapy to nivolumab or docetaxel. Nivolumab improved overall survival, the primary endpoint, as well as response rate and progression-free survival, with a fraction of the grade 3 or 4 toxicity of docetaxel. Unlike its non-squamous companion trial CheckMate 057, the benefit did not depend on PD-L1 expression, which led to nivolumab's approval in squamous disease without a biomarker requirement.

## Fields

- Kind: Key paper
- Last checked: 2026-09-08
- Journal: New England Journal of Medicine
- Year: 2015
- DOI: 10.1056/NEJMoa1504627
- Authors: Brahmer J, Reckamp KL, Baas P, et al.
- Findings: 272 patients with previously treated squamous NSCLC; nivolumab vs docetaxel.; Median overall survival 9.2 vs 6.0 months, hazard ratio 0.59; one-year survival 42% vs 24%.; Response rate 20% vs 9%; median progression-free survival 3.5 vs 2.8 months, hazard ratio 0.62.; Grade 3 or 4 treatment-related adverse events 7% vs 55%; benefit was independent of PD-L1 expression.
- What it means: With CheckMate 057 this trial ended docetaxel's role as the default second-line treatment in lung cancer and gave the first phase 3 proof that PD-1 blockade extends life in a common carcinoma. Its PD-L1-independent benefit in squamous disease still shapes how the biomarker is used.
- Caveats: Open-label design.; Second-line setting; first-line immunotherapy has since changed who reaches this point.; Squamous histology only.

## Sources

- Full text (DOI): https://doi.org/10.1056/NEJMoa1504627
- ClinicalTrials.gov NCT01642004: https://clinicaltrials.gov/study/NCT01642004

## Connected records

- key papers: [CheckMate 057: nivolumab beats docetaxel after chemotherapy in non-squamous lung cancer](https://onco.cc/key-papers/paper-checkmate-057-nejm-2015/)
- 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/)
- people: [Julie R. Brahmer](https://onco.cc/people/julie-brahmer/)
- 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/)
- ideas: [Confirm ultra-low-dose immunotherapy so it can be afforded where most patients live](https://onco.cc/ideas/idea-tr1-low-dose-immunotherapy-for-lmic/), [Give subcutaneous immunotherapy in community clinics and at home](https://onco.cc/ideas/idea-cost-subcutaneous-community/), [Make six-weekly immunotherapy the default schedule](https://onco.cc/ideas/idea-cost-extended-interval-default/), [Restore weight-based dosing and vial sharing for immunotherapy in the label](https://onco.cc/ideas/idea-reg-weight-based-io-dosing-label/)

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