1. Phase III study of selpercatinib vs chemotherapy plus /- pembrolizumab in untreated RET positive non-small-cell lung cancer
- Author
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Solomon, BJ, Zhou, CC, Drilon, A, Park, K, Wolf, J, Elamin, Y, Davis, HM, Soldatenkova, V, Sashegyi, A, Lin, AB, Lin, BK, Loong, HH, Novello, S, Arriola, E, Perol, M, Goto, K, Santini, FC, Solomon, BJ, Zhou, CC, Drilon, A, Park, K, Wolf, J, Elamin, Y, Davis, HM, Soldatenkova, V, Sashegyi, A, Lin, AB, Lin, BK, Loong, HH, Novello, S, Arriola, E, Perol, M, Goto, K, and Santini, FC
- 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).
- Published
- 2021