NCT04194944

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Selpercatinib	Administered orally
DRUG	Carboplatin	Administered IV
DRUG	Cisplatin	Administered IV
DRUG	Pemetrexed	Administered IV
DRUG	Pembrolizumab	Administered IV

Timeline

• Start date: 2020-02-17
• Primary completion: 2023-05-01
• Completion: 2030-06-01
• First posted: 2019-12-11
• Last updated: 2025-10-21
• Results posted: 2024-06-20

Locations

196 sites across 26 countries: Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Mexico, Netherlands, Poland, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study