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Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-LUNG01)

DS1062-A-U301: PHASE 3 RANDOMIZED STUDY OF DS-1062A VERSUS DOCETAXEL IN PREVIOUSLY TREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITHOUT ACTIONABLE GENOMIC ALTERATIONS (TROPION-LUNG01)

  • Clinical Trial Information

    Trial Contact: Britton, David ; Thomas, Andrea L

    Trial Phone: 321.841.2684 ; 321.841.8284

  • IRB No: W20203580

    Protocol Abbrev: TRIO DS1062-A-U301

    Principal Investigator: Tirrell Tremayne Johnson, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: TROPION-LUNG01

    Treatment: DS-1062a vs Docetaxel

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT04656652

  • Objective

    This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.

  • Key Eligibility

    Adults ≥18 years (if the legal age of consent is >18 years old, then follow local regulatory requirements)

    Life expectancy ≥3 months

    Has pathologically documented NSCLC that:
    -Has stage IIIB, IIIC, or stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition)

    -Has documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK)

    -Has no known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto oncogene B-raf (BRAF), or other actionable driver oncogenes with approved therapies (actionable genomic alteration)