Pneumologie 2025; 79(S 01): S53
DOI: 10.1055/s-0045-1804652
Abstracts
B1 – Pneumologische Onkologie

LIBRETTO-432 Trial in Progress: A Phase 3 study of adjuvant selpercatinib or placebo in Stage IB-IIIA Ret fusion-positive (RET+) NSCLC

J Goldman
1   David Geffen School of Medicine, University of California Los Angeles
,
J Sands
2   Dana-Farber Cancer Institute
,
A Hallqvist
3   Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg
,
H Kim
4   Yonsei University Severance Hospital; Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine
,
G Li
5   Chengdu Institute of Respiratory Health, Branch of National Clinical Research Center for Respiratory Disease, The Third People's Hospital of Chengdu, Affiliated Hospital of Southwest Jiaotong University
,
L Wu
6   Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
,
W Su
7   Eli Lilly and Company
,
T Bayt
7   Eli Lilly and Company
,
X Yang
8   Guangdong General Hospital & Guangdong Lung Cancer Institute
,
M Hochmair
9   Department of Respiratory and Critical Care Medicine; Karl Landsteiner Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf
,
C Grohé
10   Ev. Lungenklinik; Klinik für Pneumologie
› Author Affiliations
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    Around 30% of NSCLC patients (pts) present with stage IB-IIIA disease. Recent Phase III trial data suggest the potential for benefit for pts treated with targeted therapies in the adjuvant setting for stage IB-IIIA (ADAURA and ALINA). RET, an oncogenic driver in NSCLC is a promising target. Selpercatinib, a potent RET inhibitor, demonstrated longer PFS than platinum-based chemotherapy as 1L treatment in pts with RET+advanced NSCLC (Zhou et al. NEJM 2023). LIBRETTO-432 is a Phase 3, global trial evaluating efficacy and safety of adjuvant selpercatinib v Placebo in RET+Stage IB-IIIA NSCLC (NCT04819100).

    Pts (n≈170) will be randomized (1:1) to selpercatinib BID [160mg≥50kg; 120mg<50kg], or Placebo, in continuous 28-day cycles for 3y. Stratification factors include disease stage (IB/II/IIIA) and prior definitive therapy (surgery/radiation+/- neo-adjuvant therapy). Treatment will continue until disease recurrence/progression, unacceptable toxicity. Crossover is allowed for Placebo pts who experience disease recurrence/progression. Eligible pts include:≥18y; histologically confirmed Stage IB/II/IIIA NSCLC; RET+tumor; have undergone prior definitive locoregional therapy with curative intent. Maximum time from therapy completion to randomization is 26w. Key exclusions are other oncogenic drivers; SCLC; and disease recurrence/progression post definitive therapy. Primary endpoint is investigator-assessed event-free survival (IAEFS) in the primary analysis population (pts with Stage II-IIIA). EFS is time from randomization until locoregional disease recurrence with histopathological confirmation, metastatic disease recurrence, or death. Gated secondary endpoints include IAEFS in the overall population (including Stage 1B pts) and OS in both primary analysis and overall populations. Recruitment is ongoing, with enrollment across ~170 sites and 30 countries. Results from this trial will further inform the value of RET inhibition and genomic testing for adjuvant NSCLC pts.


     

    Publication History

    Article published online:
    18 March 2025

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