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:

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to 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)
Secondary Outcome:
  • 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 by BICR (with Pembrolizumab)
  • Intracranial ORR: Percentage of Participants with Intracranial CR or PR by BICR (with or without Pembrolizumab)
  • Intracranial DOR by BICR (with Pembrolizumab)
  • Intracranial DOR 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)

Voir cet essai sur ClinicalTrials.gov

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