Phase 2 Multicenter Randomized Study of DS-1062a in Advanced or Metastatic NSCLC w/ Actionable Genomic Alterations and Previously Treated with Kinase Inhibitor Therapy and Platinum-based Chemotherapy w/ or w/o Prior Immunotherapy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Non-small Cell Lung Cancer (nsclc)
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Has pathologically documented NSCLC that: a. Is advanced or metastatic. b. Has documented positive test results for actionable genomic alterations. 2) Has documentation of radiological disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC. 3) Willing and able to undergo a mandatory tumor biopsy for the measurement of TROP2 expression levels by immunohistochemistry (IHC) and for assessment of other biomarkers. 4) Subject must meet the following prior therapy requirements for advanced or metastatic NSCLC: a. Has received at least 1 regimen of a kinase inhibitor, and b. At least 1 regimen of platinum-based chemotherapy with or without prior immunotherapy, either in combination or sequentially. c. Has had up to 3 prior lines of therapy. 5) Archival tumor tissue from initial diagnosis is required, to the extent that archival tumor tissue is available, for measurement of TROP2 expression levels or other biomarkers.

You may not be eligible for this study if the following are true:

  • 1) Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. 2) Has leptomeningeal carcinomatosis. 3) Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.


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