Eli Lilly and Company has launched the LIBRETTO-431 Phase III clinical trial (NCT04194944) to examine selpercatinib (LOXO-292) for treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC) patients.
A total of 400 patients with advanced or metastatic RET fusion-positive NSCLC will be enrolled for the randomised Phase III LIBRETTO-431 trial.
Participants in the trial will be randomised 1:1 to receive either selpercatinib or platinum-based carboplatin or cisplatin and pemetrexed therapy with or without pembrolizumab as an initial treatment for their advanced or metastatic RET fusion-positive NSCLC.
The primary endpoint of the study is progression-free survival (PFS) and secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DoR), and intracranial ORR.
Crossover is allowed at progression for patients who are randomised to the control arm.
Lilly Oncology president Anne White said: “This is an important milestone in the journey to further demonstrate the benefit of selpercatinib and the potential for people living with advanced or metastatic RET fusion-positive non-small cell lung cancer in the first-line setting against the current standard of care.
“Launching a trial of this size underscores the importance of now including RET fusions in the paradigm of genomic testing in lung cancer.”
Selpercatinib, which has received breakthrough designations in RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers, is an oral investigational new medicine.
The drug is currently in clinical development to treat patients with cancers that harbour abnormalities in the rearranged during transfection (RET) kinase.
It can inhibit native RET signalling, as well as anticipated acquired resistance mechanisms.
In September this year, Lilly’s data from the LIBRETTO-001 clinical trial of selpercatinib showed positive response in NSCLC patients.