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A Randomized, Phase 3 Trial With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo for Patients With Early Stage NSCLC After Resection and Completion of Standard Adjuvant Therapy (PEARLS)

Trial Profile

A Randomized, Phase 3 Trial With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo for Patients With Early Stage NSCLC After Resection and Completion of Standard Adjuvant Therapy (PEARLS)

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

Latest Information Update: 11 Apr 2024

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At a glance

  • Drugs Pembrolizumab (Primary) ; Carboplatin; Cisplatin; Gemcitabine; Paclitaxel; Vinorelbine
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms EORTC-1416-LCG/ETOP-8-15; KEYNOTE-091; PEARLS
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 17 Nov 2023 Planned End Date changed from 2 Feb 2024 to 2 Feb 2027.
    • 16 Oct 2023 According to a Merck Sharp & Dohme media release, the European Commission (EC) has approved KEYTRUDA, Mercks anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy based on this trial.
    • 15 Sep 2023 According to a Merck Sharp & Dohme media release, the trial was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP).
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