The Nivolumab versus Docetaxel trial compared the effectiveness and safety of nivolumab, a PD-1 inhibitor, with docetaxel in patients with advanced squamous-cell non-small-cell lung cancer (NSCLC) who had disease progression after first-line chemotherapy. The study enrolled 272 patients, randomly assigned to receive either nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m² every 3 weeks). The primary endpoint was overall survival (OS), with nivolumab showing significantly longer OS (9.2 months vs. 6.0 months) and a 41% lower risk of death. At one year, OS rates were 42% for nivolumab versus 24% for docetaxel. Nivolumab also showed a higher response rate (20% vs. 9%) and longer progression-free survival (3.5 months vs. 2.8 months). PD-L1 expression was not prognostic or predictive of treatment benefit. Nivolumab had fewer severe adverse events (7% grade 3/4 vs. 55% for docetaxel), with fatigue, decreased appetite, and asthenia being the most common. Docetaxel was associated with more hematologic and infectious toxicities. Nivolumab showed consistent benefits across subgroups, except for older patients and those in the rest-of-the-world region. The study concluded that nivolumab was superior to docetaxel in OS, response rate, and progression-free survival, regardless of PD-L1 expression. The results led to the FDA approval of nivolumab for second-line treatment of metastatic squamous-cell NSCLC. The trial was funded by Bristol-Myers Squibb.The Nivolumab versus Docetaxel trial compared the effectiveness and safety of nivolumab, a PD-1 inhibitor, with docetaxel in patients with advanced squamous-cell non-small-cell lung cancer (NSCLC) who had disease progression after first-line chemotherapy. The study enrolled 272 patients, randomly assigned to receive either nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m² every 3 weeks). The primary endpoint was overall survival (OS), with nivolumab showing significantly longer OS (9.2 months vs. 6.0 months) and a 41% lower risk of death. At one year, OS rates were 42% for nivolumab versus 24% for docetaxel. Nivolumab also showed a higher response rate (20% vs. 9%) and longer progression-free survival (3.5 months vs. 2.8 months). PD-L1 expression was not prognostic or predictive of treatment benefit. Nivolumab had fewer severe adverse events (7% grade 3/4 vs. 55% for docetaxel), with fatigue, decreased appetite, and asthenia being the most common. Docetaxel was associated with more hematologic and infectious toxicities. Nivolumab showed consistent benefits across subgroups, except for older patients and those in the rest-of-the-world region. The study concluded that nivolumab was superior to docetaxel in OS, response rate, and progression-free survival, regardless of PD-L1 expression. The results led to the FDA approval of nivolumab for second-line treatment of metastatic squamous-cell NSCLC. The trial was funded by Bristol-Myers Squibb.