Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC

Trial Profile

Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Nov 2016

At a glance

  • Drugs Cetuximab (Primary) ; Cisplatin; Vinorelbine
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms FLEX
  • Most Recent Events

    • 18 Sep 2012 Merck voluntarily withdraws its application in the EU, seeking approval for first-line treatment of EGFR-expressing NSCLC in combination with standard, cisplatin-based chemotherapy.
    • 06 Jun 2012 New source identified and integrated (German Clinical Trials Register DRKS00003821).
    • 31 Mar 2012 Merck voluntarily withdraws its application with the US FDA seeking approval for first-line treatment of EGFR-expressing NSCLC in combination with standard, cisplatin-based chemotherapy.
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