A Phase II Study of Patritumab Deruxtecan  in People with Non-Small Cell Lung Cancer with an EGFR Mutation

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Full Title

HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects with Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug patritumab deruxtecan in patients with non-small cell lung cancer (NSCLC) that contains an EGFR mutation and continued to grow despite prior treatment. Researchers have found that NSCLCs with an EGFR mutation commonly express the HER3 protein, one of several proteins that may cause cancer cells to grow. Patritumab deruxtecan brings chemotherapy inside HER3-positive cancer cells and kills them. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic NSCLC that came back or continued to grow despite prior chemotherapy and a targeted therapy, such as osimertinib.
  • Patients should recover from the serious side effects of prior treatment before receiving patritumab deruxtecan.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Helena Yu at 646-608-3912.

Protocol

21-185

Phase

II

Investigator

Co-Investigators