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Nivolumab
Source: Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 15, 2025 · Captured 2026-09-09.
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Evidence (nivolumab):
In two phase III clinical trials, one conducted in patients with advanced platinum-pretreated squamous NSCLC and the other trial conducted in patients with nonsquamous NSCLC, nivolumab demonstrated a significant improvement in OS compared with the previous standard treatment of docetaxel chemotherapy.[62,63][Level of evidence A1] In addition, the rates of grade 3 and 4 treatment-related toxicity in both trials were significantly lower with nivolumab than with docetaxel. Of note, all patients enrolled in phase III studies of nivolumab had an ECOG performance status of 0 or 1; patients with autoimmune disease, symptomatic interstitial lung disease, or those receiving systemic immunosuppression were excluded from enrollment.
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A randomized, open-label, phase III trial randomly assigned 272 patients with advanced squamous cell NSCLC who had received one regimen of platinum-containing chemotherapy to receive either nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks), administered until disease progression.[62] The primary end point of this study was OS.
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A randomized, open-label, phase III trial randomly assigned 272 patients with advanced squamous cell NSCLC who had received one regimen of platinum-containing chemotherapy to receive either nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks), administered until disease progression.[62] The primary end point of this study was OS.
Nivolumab demonstrated a significant improvement in median OS compared with docetaxel (9.2 months vs. 6 months; P < .001). In addition, the response rate (20% vs. 9%; P = .008) and median PFS (3.5 months vs. 2.8 months; P < .001) favored nivolumab.
A randomized, open-label, phase III trial randomly assigned 272 patients with advanced squamous cell NSCLC who had received one regimen of platinum-containing chemotherapy to receive either nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks), administered until disease progression.[62] The primary end point of this study was OS.
Rates of treatment-related toxicity were significantly lower with nivolumab than with docetaxel (all grades, 58% for nivolumab vs. 86% for docetaxel; grades 3–4, 7% for nivolumab vs. 55% for docetaxel).
A randomized, open-label, phase III trial included 582 patients with advanced nonsquamous NSCLC who had received one regimen of platinum-containing chemotherapy. Patients were randomly assigned to receive either nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks), administered until disease progression.[63] Previous maintenance chemotherapy after first-line platinum-doublet was allowed; patients with EGFR variants or ALK translocations were allowed to have received an additional regimen of therapy with a TKI. The primary end point of this study was OS.
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A randomized, open-label, phase III trial included 582 patients with advanced nonsquamous NSCLC who had received one regimen of platinum-containing chemotherapy. Patients were randomly assigned to receive either nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks), administered until disease progression.[63] Previous maintenance chemotherapy after first-line platinum-doublet was allowed; patients with EGFR variants or ALK translocations were allowed to have received an additional regimen of therapy with a TKI. The primary end point of this study was OS.
Patients who received nivolumab had a significant improvement in median OS compared with patients who received docetaxel (12.2 months vs. 9.4 months; HR, 0.73; 96% CI, 0.59–0.89; P = .002). In this study, the response rate (19% vs. 12%; P = .02) but not median PFS (2.3 months for nivolumab vs. 4.2 months for docetaxel) favored nivolumab. The median DOR in patients was 17.2 months for nivolumab and 5.6 months for docetaxel.
A randomized, open-label, phase III trial included 582 patients with advanced nonsquamous NSCLC who had received one regimen of platinum-containing chemotherapy. Patients were randomly assigned to receive either nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks), administered until disease progression.[63] Previous maintenance chemotherapy after first-line platinum-doublet was allowed; patients with EGFR variants or ALK translocations were allowed to have received an additional regimen of therapy with a TKI. The primary end point of this study was OS.
Rates of treatment-related toxicity were significantly lower with nivolumab than with docetaxel (all grades, 69% for nivolumab vs. 88% for docetaxel; grades 3–4, 10% for nivolumab vs. 54% for docetaxel).
Both of these trials demonstrated long-term clinical benefit at the 2-year outcomes. The OS rates for nivolumab at 2 years compared with docetaxel in squamous NSCLC were 23% (95% CI, 16%–30%) versus 8% (95% CI, 4%–13%), and OS rates in nonsquamous NSCLC were 29% (95% CI, 24%–34%) versus 16% (95% CI, 12%–20%).[65] Ongoing responses at 2 years were observed in 10 (37%) confirmed responders with squamous NSCLC and 19 (34%) of 56 responders with nonsquamous NSCLC. No patient treated with docetaxel in either study had an ongoing response.
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Nivolumab is now considered a standard second-line therapy for patients with metastatic NSCLC with progression during or after first-line platinum-based chemotherapy and is associated with improved survival and lower rates of toxicity than docetaxel. However, clinical trials of nivolumab to date have not enrolled patients with a history of autoimmune disease, interstitial lung disease, or an ECOG performance status higher than 1. Patients with active autoimmune conditions cannot be treated with nivolumab. Closely monitoring all patients for autoimmune toxicities from treatment is required. Specific algorithms for the management of autoimmune toxicity are included in the FDA label for nivolumab.
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Preserved source evidence · Not medical advice