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

Titre officiel

LIBRETTO-431: A Multicentre, 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

Sommaire:

Cette étude a pour but de vérifier si le médicament à l’étude, le selpercatinib, comparativement à un traitement standard, est efficace et sûr chez les participants atteints d’un cancer du poumon non à petites cellules (CPNPC) non squameux positif pour la fusion RET (réarrangement pendant la transfection) s’étant propagé à d’autres parties du corps. Les participants qui se voient attribuer le traitement standard et qui l’interrompent à la suite d’une progression de la maladie ont la possibilité de passer au selpercatinib.

Description de l'essai

Primary Outcome:

• Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (with Pembrolizumab)
• PFS by BICR (with or without Pembrolizumab)

• Disease Control Rate (DCR) by BICR (with Pembrolizumab)
• DCR by BICR (with or without Pembrolizumab)
• PFS2 (with Pembrolizumab)
• PFS2 (with or without Pembrolizumab)
• Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) by BICR (with Pembrolizumab)
• ORR: Percentage of Participants with CR or PR by BICR (with or without Pembrolizumab)
• Duration of Response (DoR) by BICR (with Pembrolizumab)
• DOR by BICR (with or without Pembrolizumab)
• Overall Survival (OS) (with Pembrolizumab)
• OS (with or without Pembrolizumab)
• Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST (Response Evaluation Criteria in Solid Tumours) 1.1 by BICR (with Pembrolizumab)
• Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab)
• Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab)
• Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab)
• Time to Deterioration of Pulmonary Symptoms (with Pembrolizumab)
• Time to Deterioration of Pulmonary Symptoms (with or without Pembrolizumab)
• The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement)
• Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab)
• Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab)
• Intracranial ORR: Percentage of Participants with Intracranial CR or PR per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) by BICR (with Pembrolizumab)
• Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab)
• Intracranial DOR per RANO-BM by BICR (with Pembrolizumab)
• Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab)

Voir cet essai sur ClinicalTrials.gov