CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 261 enrolled
Drug / intervention
Selpercatinib +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04194944
NCT04194944Phase 3Active

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

Eli Lilly and Company·interventional·Posted Dec 11, 2019·Updated Oct 21, 2025

In Brief

A Phase 3 clinical trial evaluating Selpercatinib, Carboplatin, and 3 other interventions for Non-Small Cell Lung Cancer. Active but no longer recruiting, targeting 261 participants across 196 sites in 26 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, 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
CollaboratorsLoxo Oncology, Inc.

Timeline

Phase 3Active
20202021202220232024202520262027202820292030
First PostedDec 11, 2019
Enrollment StartFeb 17, 2020
Primary CompletionMay 1, 2023
Study CompletionJun 1, 2030
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.6 years ago

Interventions

Selpercatinibdrug

Administered orally

Carboplatindrug

Administered IV

Cisplatindrug

Administered IV

Pemetrexeddrug

Administered IV

Pembrolizumabdrug

Administered IV