Eli Lilly has kicked off the first ever randomised Phase III study in treatment-naïve RET fusion-positive non-small cell lung cancer.

The LIBRETTO-431 clinical trial is assessing selpercatinib, also known as LOXO-292, for treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC) patients.

The trial aims to enroll around 400 participants, who will be randomised to receive either selpercatinib or platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab as initial treatment.

"This trial endeavors to generate outcome data that place patients with RET fusions alongside those with EGFR mutations and ALK fusions, as driver-positive populations that should be treated with targeted therapies in the first-line setting, rather than chemoimmunotherapy,” said Professor Ben Solomon, principal investigator at the Peter MacCallum Cancer Centre in Melbourne Australia.

Selpercatinib is a highly selective and potent, oral investigational new medicine in clinical development for the treatment of patients with cancers that harbour abnormalities in the rearranged during transfection (RET) kinase, the firm noted.

RET fusions and mutations occur across multiple tumor types with varying frequency. Selpercatinib was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms.

Lilly picked up rights to the drug earlier this year when it bought Loxo Oncology for $8 billion.