An Open-Label, Randomized, Controlled Phase II Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab versus Paclitaxel-Carboplatin Alone in First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer

Abstract Background Addition of necitumumab to gemcitabine-cisplatin significantly improved overall survival (OS) in patients with Stage IV squamous non-small cell lung cancer (NSCLC), in the phase III SQUIRE trial. Paclitaxel-carboplatin was selected as an alternative standard of care in this phase II study. Patients and Methods Patients were randomized (stratified by Eastern Cooperative Oncology Group performance status and sex) 2:1 to ≤six 3-week cycles (Q3W) of paclitaxel and carboplatin with/without necitumumab. Chemotherapy was paclitaxel 200 mg/m on Day 1 Q3W and carboplatin AUC 6 on Day 1 Q3W. Necitumumab 800 mg, on Days 1 and 8, was continued until disease progression or intolerable toxicity occurred. The primary end point was objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. ClinicalTrails.gov , NCT01769391. Results 167 patients were randomized to the necitumumab-containing arm (n=110) or the chemotherapy-only arm (n=57). Addition of necitumumab to chemotherapy resulted in ORR 48.9% versus 40.0%. Median progression-free survival and OS were 5.4 versus 5.6 months (hazard ratio [HR]=1.0) and 13.2 versus 11.2 months (HR=0.83; P =.379) in each treatment arm, respectively. Disease control rate was 87.2% versus 84.0%. Grade ≥3 adverse events typically associated with EGFR monoclonal antibodies showing a >2% increase were hypomagnesemia (5.7% versus 0) and rash (2.8% versus 0). Any grade thromboembolic events occurred in