Open AccessPhase III study of selpercatinib versus chemotherapy ± pembrolizumab in untreated RET positive non-small-cell lung cancer
Author(s) -
Benjamin Solomon,
C. 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. F. Loong,
Silvia Novello,
Edurne Arriola,
M. Pérol,
Kōichi Goto,
Fernando C. Santini
Publication year - 2021
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2020-0935
Subject(s) - medicine , pemetrexed , carboplatin , pembrolizumab , oncology , lung cancer , clinical endpoint , chemotherapy , cisplatin , phases of clinical research , clinical trial , progression free survival , cancer , immunotherapy
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)