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A Phase II Study of the BRAF Inhibitor Dabrafenib as a Single Agent and in Combination With the MEK Inhibitor Trametinib in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer

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Trial Profile

A Phase II Study of the BRAF Inhibitor Dabrafenib as a Single Agent and in Combination With the MEK Inhibitor Trametinib in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Jul 2022

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At a glance

  • Drugs Dabrafenib (Primary) ; Trametinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Therapeutic Use
  • Sponsors GlaxoSmithKline; GSK; Novartis Pharma A.G.; Novartis Pharmaceuticals

    • Most Recent Events

    • 22 Jun 2022 According to a Food and Drug Administration media release, the Food and Drug Administration granted accelerated approval to dabrafenib in combination with trametinib for the treatment of adult and pediatric patients greater than equal to 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
    • 26 Aug 2021 Results published in the Journal of Thoracic Oncology
    • 02 Jul 2021 Results (n=1076) of pooled analysis charactering the incidence, patterns and management of pyrexia in patients receiving dabrafenib plus trametinib in clinical trials (NCT01336634, NCT01682083, NCT01584648, NCT01597908) published in the European Journal of Cancer

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