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LIBRETTO-431: A Multicenter, 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

Trial Profile

LIBRETTO-431: A Multicenter, 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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Feb 2025

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At a glance

  • Drugs Selpercatinib (Primary) ; Carboplatin; Cisplatin; Pembrolizumab; Pemetrexed
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms LIBRETTO-431
  • Sponsors Eli Lilly and Company; Eli Lilly Japan

Most Recent Events

  • 30 Jan 2025 Planned End Date changed from 18 Jun 2026 to 1 Jun 2026.
  • 01 Dec 2024 Results evaluating the cost-effectiveness of selpercatinib versus chemotherapy and pembrolizumab in the first-line treatment of RET fusion-positive NSCLC from the perspective of the United States (US) payer by developing a partitioned survival model using data from this trial published in the International Journal of Clinical Pharmacy
  • 04 Jun 2024 Results (cut-off date: May 01, 2023)Health-related quality of life (HRQoL) and symptoms in patients with RET fusion-positive advanced non-small-cell lung cancer, presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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