Status: Active Trial | Marker: ALK, NTRK, ROS1
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
Study Number
NCT04194944
Indication
Histologically or cytologically confirmed Stage IIIB-IIIC or Stage IV NSCLC that is not suitable for radical surgery or radiation therapy (Lim et al. 2018). The histology of the tumor must be predominantly nonsquamous. Squamous cell and/or mixed small cell/nonsmall cell histology is not permitted.
Primary Objective
To determine the confirmed ORR as assessed by BICR of repotrectinib in each subject population expansion cohort of solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
In- and exclusion Criteria
Must have a RET gene fusion in tumor using PCR or NGS. Results in blood using NGS are also acceptable.

  • The RET gene fusion result should be generated from a laboratory with CLIA,ISO/IEC, CAP, or other similar certification that clearly denotes the presence of a RET alteration. Blood results must be determined on a platform that meets these standards and is also Lilly approved.
  • In all cases, the presence of the RET fusion must be confirmed upon review of the pathology report by Lilly or designee prior to enrollment.
Study Design
Phase II, multicentric, randomized
Responsibilities
Eli Lilly and Company, Indianapolis, Indiana, USA 46285 San Diego, CA 92121
Trial Centre
University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010

lungenkrebs@uk-koeln.de

Principal investigator
Prof. Dr. Jürgen Wolf

Letzte Änderung: 1. October 2020