Phase III Study of Selpercatinib Versus Chemotherapy ± pembrolizumab in Untreated <i>RET</i> Positive Non-Small-Cell Lung Cancer
Benjamin Solomon, Cai Cun Zhou, Alexander Drilon, Keunchil Park, Jürgen Wolf, Yasir Y. Elamin, Hannah M. Davis, Victoria Soldatenkova, Andreas Sashegyi, Aimee Bence Lin, Boris K. Lin, Herbert H. Loong, Silvia Novello, Edurne Arriola, M. Pérol, Kōichi Goto, Fernando C. Santini
Abstract
Selpercatinib, a novel, highly selective and potent, inhibitor of RET, demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pretreated and treatment-naive RET fusion-positive non-small-cell lung cancer patients in a Phase I/II clinical trial. LIBRETTO-431 (NCT04194944) is a randomized, global, multicenter, open-label, Phase III trial, evaluating selpercatinib versus carboplatin or cisplatin and pemetrexed chemotherapy with or without pembrolizumab in treatment-naive patients with locally advanced/metastatic RET fusion-positive nonsquamous non-small-cell lung cancer. The primary end point is progression-free survival by independent review. Key secondary end points include overall survival, response rate, duration of response and progression-free survival. Clinical trial registration: NCT04194944 (ClinicalTrials.gov)