A phase II study of nab-paclitaxel and carboplatin chemotherapy plus necitumumab in the first-line treatment of patients with stage IV squamous non-small cell lung cancer

Objectives: Necitumumab is a second-generation, recombinant, human IgG1-type monoclonal antibody directed against EGFR approved for adult patients with metastatic squamous non-small cell lung cancer (NSCLC) in combination with gemcitabine and cisplatin. This study assessed the efficacy and safety of albumin-bound paclitaxel (nab-paclitaxel) and carboplatin in combination with necitumumab as first-line therapy in patients with stage IV squamous NSCLC. Materials and methods: The treatment regimen comprised triplet induction with necitumumab (800 mg) with nab-paclitaxel (100 mg/m(2)) and carboplatin (AUC 6 mg*min/mL) for 4 cycles, followed by doublet maintenance with necitumumab and nab-paclitaxel with a 3-weekly schedule until progressive disease or unacceptable toxicity. The primary endpoint of the study was objective response rate (ORR). Results: Fifty-four patients were enrolled. Median age was 65 years (range, 47-80 years). The majority of the patients were male (n = 42 [77.8%]) with an ECOG PS of 1 (n = 42 [77.8%]). The ORR was 51% (n = 26/54), and the disease control rate was 78.4% (n = 40/54). Median overall survival (OS) was 15.5 months (95% confidence interval [CI]: 10.18-not calculable), and the OS rate at 12 months was 50.4% (95% CI: 29.0-68.4). Median progression-free survival was 5.6 months (95% CI: 4.24-7.69)]. The most frequently reported treatment-emergent adverse events were anemia (57.4%), fatigue (55.6%), neutrophil count decreased (55.6%), hypomagnesemia (44.4%), and rash (38.9%). Conclusion: Necitumumab/nab-paclitaxel/carboplatin first-line therapy produced favorable efficacy outcomes with manageable toxicity in patients with stage IV squamous NSCLC. The safety profile was fairly comparable with previous necitumumab combination studies in lung cancer.