Phase 1/2 Study Of PF-06463922 (an Alk/ros1 Tyrosine Kinase Inhibitor) In Patients With Advanced Non-small Cell Lung Cancer Harboring Specific Molecular Alterations

Trial Profile

Phase 1/2 Study Of PF-06463922 (an Alk/ros1 Tyrosine Kinase Inhibitor) In Patients With Advanced Non-small Cell Lung Cancer Harboring Specific Molecular Alterations

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 18 Feb 2018

At a glance

  • Drugs Lorlatinib (Primary) ; Crizotinib; Midazolam
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Pfizer
  • Most Recent Events

    • 12 Feb 2018 Planned End Date changed from 19 Feb 2019 to 1 Feb 2019.
    • 12 Feb 2018 According to a Pfizer media release, European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency have also accepted marketing applications for the use of lorlatinib. The submissions were based on Phase 2 data from this trial.
    • 12 Feb 2018 According to a Pfizer media release, the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the company's New Drug Application (NDA) of lorlatinib for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC). The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2018. The submission was based on Phase 2 data from this trial.
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