OncRef

Clinical Trial: NCT04194944

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Eli Lilly and Company
Information Provided By:Eli Lilly and Company
Last Update Posted:2026-10-21

Study Overview

Brief 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.

Official Title

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

Conditions

Non-Small Cell Lung Cancer

Intervention / Treatment

  • Drug: Selpercatinib
  • Drug: Carboplatin
  • Drug: Cisplatin
  • Drug: Pemetrexed
  • Drug: Pembrolizumab

Other Study ID Numbers

  • 17479
  • J2G-MC-JZJC
  • 2019-001979-36
  • 2019

Start Date (Actual)

2020-02-17

Primary Completion Date (Actual)

2023-05-01

Study Completion Date (Estimated)

2030-06

Enrollment (Actual)

261

Study Type

Interventional

Phase

Phase 3