Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC

CK-301-301 is a Phase 3, open-label, multicenter, randomized, active-controlled study of the safety and efficacy of IV administered cosibelimab 1200 mg Q3W in combination with platinum/pemetrexed chemotherapy versus chemotherapy alone in subjects with NSCLC who have not previously received systemic therapy for advanced disease and in whom epidermal growth factor receptor-directed therapy or anaplastic lymphoma kinase-directed therapy was not indicated. Subjects were randomized 2:1 to receive cosibelimab 1200 mg in combination with pemetrexed and platinum therapy, or pemetrexed and platinum therapy alone. Subjects were stratified by smoking status (never versus former/current), cisplatin vs carboplatin, and PD-L1 status (Tumor Proportion Score \[TPS\] \< 1% vs 1-49% vs ≥ 50%) prior to randomization. Subjects with unevaluable PD-L1 status were included with the TPS \< 1% group.