OncRef

Clinical Trial: NCT04819100

A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Eli Lilly and Company
Information Provided By:Eli Lilly and Company
Last Update Posted:2026-03-04

Study Overview

Brief Summary

The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.

Official Title

LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention / Treatment

  • Drug: Selpercatinib
  • Drug: Placebo

Other Study ID Numbers

  • 18126
  • J2G-MC-JZJX
  • 2020-005191-35
  • 2023-506784-33-00
  • 2023

Start Date (Actual)

2021-12-20

Primary Completion Date (Actual)

2026-01-12

Study Completion Date (Estimated)

2028-05

Enrollment (Estimated)

152

Study Type

Interventional

Phase

Phase 3