Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer
Open accessAbstract
BACKGROUND: Patients with advanced squamous-cell non-small-cell lung cancer (NSCLC) who have disease progression during or after first-line chemotherapy have limited treatment options. This randomized, open-label, international, phase 3 study evaluated the efficacy and safety of nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, as compared with docetaxel in this patient population. METHODS: We randomly assigned 272 patients to receive nivolumab, at a dose of 3 mg per kilogram of body weight every 2 weeks, or docetaxel, at a dose of 75 mg per square meter of body-surface area every 3 weeks. The primary end point was overall survival. RESULTS: The median overall survival was 9.2 months (95% confidence interval [CI], 7.3 to 13.3) with nivolumab versus 6.0 months (95% CI, 5.1 to 7.3) with docetaxel. The risk of death was 41% lower with nivolumab than with docetaxel (hazard ratio, 0.59; 95% CI, 0.44 to 0.79; P<0.001). At 1 year, the overall survival rate was 42% (95% CI, 34 to 50) with nivolumab versus 24% (95% CI, 17 to 31) with docetaxel. The response rate was 20% with nivolumab versus 9% with docetaxel (P=0.008). The median progression-free survival was 3.5 months with nivolumab versus 2.8 months with docetaxel (hazard ratio for death or disease progression, 0.62; 95% CI, 0.47 to 0.81; P<0.001). The expression of the PD-1 ligand (PD-L1) was neither prognostic nor predictive of benefit. Treatment-related adverse events of grade 3 or 4 were reported in 7% of the patients in the nivolumab group as compared with 55% of those in the docetaxel group. CONCLUSIONS: Among patients with advanced, previously treated squamous-cell NSCLC, overall survival, response rate, and progression-free survival were significantly better with nivolumab than with docetaxel, regardless of PD-L1 expression level. (Funded by Bristol-Myers Squibb; CheckMate 017 ClinicalTrials.gov number, NCT01642004.).
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Nivolumab has significantly improved outcomes in patients with metastatic non-small cell lung cancer (NSCLC).
“Nivolumab has significantly improved outcomes in patients with metastatic non-small cell lung cancer (NSCLC); however, reliable prognostic biomarkers remain an unmet need.”
From SUVmax-IPI as a New Prognostic Index in Metastatic Non-Small Cell Lung Cancer Patients Receiving Nivolumab (2025) · cites this paper as [3]
The Conclusions (p. 1) report significantly better survival, response rate, and progression-free survival with nivolumab than with docetaxel. But the study was limited to patients with advanced, previously treated squamous-cell NSCLC; the claim does not retain those qualifiers and reads as applying to metastatic NSCLC more broadly. (LLM, conf=0.86)
Experimental — accuracy not yet measuredImmune checkpoint inhibitors targeting PD-1/PD-L1 have changed the treatment landscape for advanced non-small-cell lung cancer.
“The development of immune checkpoint inhibitors (ICI) targeting the PD-1/PD-L1 interaction has transformed the therapeutic landscape of patients with advanced non-small cell lung cancer (NSCLC) [1][2][3][4][5][6] .”
From Intestinal Akkermansia muciniphila predicts clinical response to PD-1 blockade in patients with advanced non-small-cell lung cancer (2022) · cites this paper as [2]
In previously treated advanced NSCLC, PD-1/PD-L1 blockade improved overall survival compared with standard chemotherapy.
“Landmark trials performed on previously treated patients with advanced NSCLC demonstrated superior overall survival (OS) with PD-1/PD-L1 blockade compared to standard chemotherapy [1][2][3] .”
From Intestinal Akkermansia muciniphila predicts clinical response to PD-1 blockade in patients with advanced non-small-cell lung cancer (2022) · cites this paper as [2]
PD-L1 expression on tumor cells was not correlated with treatment efficacy in patients with squamous cell carcinoma, non-small cell lung cancer and Merkel cell carcinoma.
“Although PD-L1 expression on tumor cells was correlated with treatment efficacy in melanoma patients (67, 108), it was not in patients with squamous cell carcinoma, non-small cell lung cancer and Merkel cell carcinoma (70, 72, 74).”
From Anti-PD-1 and Anti-CTLA-4 Therapies in Cancer: Mechanisms of Action, Efficacy, and Limitations (2018) · cites this paper as [72]
In CheckMate 017, median OS was 9.2 months with nivolumab versus 6.0 months with docetaxel, with a 41% reduction in risk of death (HR 0.59, 95% CI 0.44-0.49, P<0.001).
“At the data cut-off, median OS was 9.2 months (95% CI: 7.3-13.3months) on nivolumab compared with 6.0 months (95% CI: 5.1-7.3months) on docetaxel, with a 41% reduction in the risk of death in the nivolumab arm (HR 0.59, 95% CI: 0.44-0.49;P < 0.001).”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [98]
In CheckMate 017, PD-L1 expression was neither prognostic nor predictive of clinical benefit in a retrospective analysis using various cut points.
“The expression of PD-L1 was neither prognostic nor predictive of clinical benefit in a retrospective analysis using various cut points in this study.”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [98]
In CheckMate 017, nivolumab 3 mg/kg every 2 weeks improved survival by 3.2 months compared with docetaxel in previously treated SCC.
“A phase III trial (CheckMate 017) in patients previously treated for SCC compared 3 mg/kg of nivolumab given every 2 weeks with docetaxel, showing an improvement of 3.2 months [97,98]”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [98]
Nivolumab was better tolerated than docetaxel, with 85% versus 69% receiving at least 90% of planned dose intensity and treatment discontinuation rates of 10% versus 3%.
“In the phase III trial, nivolumab was better tolerated than docetaxel, with 85% of nivolumab patients receiving at least 90% of their planned dose intensity, compared with 69% of docetaxel patients, together with a treatment discontinuation rate of 10% versus 3% of the patients treated with nivolumab and docetaxel, respectively.”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [98]
A phase II trial of single-agent nivolumab in patients with SCC who had received at least two prior regimens had an overall response rate of 14.5% (17 of 117; 95% CI, 8.7 to 22.2).
“The primary end point was overall response rate, which occurred in 17 (14.5%) of 117 patients (95% CI 8.7 to 22.2).”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [98]
In that phase II nivolumab trial, median time to response was 3.3 months, and median duration of response had not been reached at publication.
“Median time to response was 3.3 months; median duration of response had not been reached at the time of publication.”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [98]
In that phase II nivolumab trial, adverse effects included dyspnea, fatigue, pneumonitis, diarrhea, musculoskeletal pain, and severe immune-mediated adverse effects, and 59% of patients experienced serious adverse events.
“Adverse effects included dyspnea, fatigue, pneumonitis, diarrhea, musculoskeletal pain, and severe immune-mediated adverse effects98,99; 59% of patients experienced serious adverse events.100”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [98]
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- Authors
- Brahmer, J., Reckamp, K. L., Baas, P., Crinò, L., Eberhardt, W. E. E., Poddubskaya, E., Antonia, S., Pluzanski, A., Vokes, E. E., Holgado, E., Waterhouse, D., Ready, N., Gainor, J., Arén Frontera, O., Havel, L., Steins, M., Garassino, M. C., Aerts, J. G., Domine, M., Paz-Ares, L., Reck, M., Baudelet, C., Harbison, C. T., Lestini, B., & Spigel, D. R.
- Affiliations
- City Of Hope National Medical Center (US)
- The Netherlands Cancer Institute (NL)
- University of Perugia (IT)
- Ruhrlandklinik (DE)
- Russian Cancer Research Center NN Blokhin (RU)
- Moffitt Cancer Center (US)
- University of Chicago (US)
- Oncology Hematology Care (US)
- Duke Medical Center (US)
- Massachusetts General Hospital (US)
- Fakultní nemocnice Bulovka (CZ)
- University Hospital Heidelberg (DE)
- Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
- Amphia Ziekenhuis (NL)
- Hospital Universitario Virgen del Rocío (ES)
- LungenClinic Grosshansdorf (DE)
- Bristol-Myers Squibb (United States) (US)
- Tennessee Oncology (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-07-09
- Volume
- 373
- Issue
- 2
- Pages
- 123-135
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4681400
- OpenAlex
- W2156353875
- Cited by
- 8,447
- References
- 22
- Citations by year
- 2026: 204 · 2025: 332 · 2024: 525 · 2023: 627 · 2022: 718 · 2021: 928 · 2020: 1065 · 2019: 969 · 2018: 1066 · 2017: 1001 · 2016: 803 · 2015: 184 · 2014: 6 · 2013: 2
- FWCI
- 444.63
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Funders
- National Cancer Institute (P30CA076292)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- nivolumab, docetaxel, squamous cell non-small cell lung cancer, PD-1 inhibitors, immune checkpoint inhibitors, overall survival, progression-free survival, PD-L1 expression, treatment-related adverse events, second-line therapy, previously treated patients, response rate, treatment safety and efficacy comparison, immunotherapy versus chemotherapy
- MeSH terms
- Docetaxel, Nivolumab, Adult, Aged, Antibodies, Monoclonal, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Female, Humans, Immunoglobulin G, Lung Neoplasms, Male, Middle Aged, Survival Analysis, Taxoids, B7-H1 Antigen, Programmed Cell Death 1 Receptor
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