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: 02 Aug 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

    • 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.
    • 26 May 2017 According to a Novartis media release, based on the data from this trial, US Food and Drug Administration (FDA) approved the expanded use of Zykadia(ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.
    • 19 May 2017 According to a Novartis media release, based on the data from this trial the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinion and recommended approval of 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. The CHMP recommendation will now be reviewed by the European Commission.
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