A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer

Trial Profile

A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Sep 2017

At a glance

  • Drugs Ceritinib (Primary) ; Carboplatin; Cisplatin; Pemetrexed
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ASCEND 4
  • Sponsors Novartis
  • Most Recent Events

    • 15 Sep 2017 The study has been competed in Denmark.
    • 24 Aug 2017 Planned End Date changed from 1 Jun 2018 to 22 Jul 2019.
    • 29 Jun 2017 According to a Novartis media release, based on the data from this trial, the European Commission approved expanding the use of Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. Approval is is applicable to all 28 European Union member states plus Iceland, Lichtenstein, and Norway.
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