* LIBRETTO-432-JZJX
Research type
Research Study
Full title
LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive ocoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC
IRAS ID
295834
Contact name
Siow Ming-Lee
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2020-005191-35
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
10 years, 10 months, 1 days
Research summary
Non-small cell lung cancer (NSCLC) is the most common type of cancer and the most common cause of cancer deaths worldwide, with an estimated 2.3 million new cases and 1.8 million deaths in 2020. Some patients have specific changes to genes in their tumours that drive the growth of the tumour. One of these changes is RET fusion. The change to the RET gene causes the body to make an abnormal RET protein, which can lead to uncontrolled cell growth and cancer.
Selpercatinib works by blocking the action of the abnormal RET proteins and may slow or stop the growth of the cancer. It may also help to shrink the cancer. The first in man trial, LIBRETTO-001 was initiated in 2017 to assess the safety, pharmacokinetic, and anti-tumour activity of selpercatinib in participants with RET-altered solid tumours. Data from this study was used to support the approval of selpercatinib by the FDA and EMA in 2020, including RET fusion-positive metastatic NSCLC.The study LIBRETTO-432 is a global, multicentre, randomized (1:1), double-blind, Phase 3 study comparing the efficacy and safety of selpercatinib to placebo in participants with RET fusion-positive Stage IB-IIIA NSCLC following completion of therapies with a curative intent, e.g., definitive locoregional treatment (such as surgery or radiotherapy) and applicable adjuvant chemotherapy. Trial participants must be 18 years of age, have histologically confirmed Stage IB, II, or IIIA NSCLC, have an activating RET gene fusion in tumour and have received definitive locoregional therapy with curative intent (surgery or radiotherapy). Study participants will receive either selpercatinib or placebo twice daily in a continuous 28-day cycles. Approximately 170 patients will be enrolled globally including approximately 5 trial participants from the UK. The maximum treatment duration will be 3 years.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0153
Date of REC Opinion
8 Jul 2021
REC opinion
Further Information Favourable Opinion