CheckMate 331: An open-label, randomized phase III trial of nivolumab versus chemotherapy in patients (pts) with relapsed small cell lung cancer (SCLC) after first-line platinum-based chemotherapy (PT-DC).

Abstract

TPS8578 Background: Overall survival (OS) remains poor in pts with advanced SCLC, and treatment options are limited for pts who relapse after first-line PT-DC. Nivolumab, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor, has demonstrated superior survival and favorable safety over docetaxel in two phase III trials in previously treated advanced non-small cell lung cancer (NSCLC). These results led to the approval of nivolumab in the US for previously treated metastatic NSCLC and in the EU for previously treated squamous (SQ) NSCLC. In a phase I/II trial (CheckMate 032) in pts with advanced/metastatic solid tumors, nivolumab monotherapy showed antitumor activity with durable tumor responses in pts with SCLC whose disease progressed after ≥ 1 prior therapy. In this study, responses were observed regardless of programmed death ligand-1 (PD-L1) expression or platinum sensitivity/resistance. Adverse event profiles of nivolumab were manageable and favorable compared to safety profiles of historical topotecan or amrubicin data. These encouraging data have led to a phase III trial, CheckMate 331, designed to evaluate nivolumab monotherapy versus chemotherapy in pts with relapsed SCLC. Methods: Adult pts with limited or extensive disease SCLC, disease progression or recurrence after first-line PT-DC or chemoradiation therapy, and ECOG performance status 0–1 are eligible. Pts with symptomatic and active brain metastases are ineligible. The primary endpoint is OS. Secondary endpoints include progression-free survival and objective response rate. An estimated 480 pts will be enrolled and randomized 1:1 to nivolumab or chemotherapy (topotecan in the US or EU, and topotecan or amrubicin in Japan). Clinical trial information: NCT02481830.