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

Official Title

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

Summary:

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.

Trial Description

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)

View this trial on ClinicalTrials.gov