LIBRETTO-432, a Phase III Study of Adjuvant Selpercatinib or Placebo in Stage IB-IIIA RET Fusion-Positive Non-Small-Cell Lung Cancer
Year: 2022
Type: article
Abstract: Selpercatinib, a first-in-class, highly selective and potent central nervous system-active RET kinase inhibitor demonstrated clinically meaningful activity with manageable toxicity in pretreated and treatment-naive advanced/metastatic RET fusion-positive non-small-cell lung cancer (NSCLC). LIBRETTO-432 is a global, randomized, double-blind, phase III trial evaluating selpercatinib versus placebo in stage IB-IIIA, RET fusion-positive NSCLC, previously treated with definitive surgery or radiation; participants must have undergone available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, per investigator's discretion. The primary end point is investigator-assessed event-free survival (EFS) in the primary analysis population (stage II-IIIA RET fusion-positive NSCLC). Key secondary end points include EFS in the overall population, overall survival, and time to distant disease recurrence in the central nervous system.
Source: Future Oncology
Institutions: National Cancer Center Hospital East, University of California, Los Angeles, Guangdong Academy of Medical Sciences, Guangdong Provincial People's Hospital, Sarah Cannon, Hospital Universitario 12 De Octubre, National Taiwan University, National Taiwan University Hospital, Université Paris-Saclay, Institut Gustave Roussy, Eli Lilly (United States), Memorial Sloan Kettering Cancer Center, Cornell University, Weill Cornell Medicine
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funder: Eli Lilly and Company
OpenAlex ID: W4292745296