A Phase II Study of Trastuzumab Deruxtecan in Patients with Advanced HER2-Positive or HER2-Mutant Non-Small Cell Lung Cancer

Full Title

A Phase 2, Multicenter, Open-Label, 2-Cohort Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2 Antibody Drug Conjugate (ADC), for HER2-Over-Expressing or -Mutated, Unresectable and/or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Purpose

Trastuzumab is an antibody that inhibits a protein called HER2 which is found in large amounts on some cancers, such as breast cancer. In this study, researchers are evaluating the safety and effectiveness of trastuzumab attached to the anticancer drug deruxtecan in patients with advanced non-small cell lung cancer (NSCLC) that produces too much of the HER2 protein or has mutations in the HER2 gene. Trastuzumab binds to cancer cells with HER2 overexpression or mutations so deruxtecan can be delivered directly into the cancer cell to kill it from within.

Trastuzumab deruxtecan 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 non-squamous NSCLC that cannot be successfully treated using standard therapies.
  • Patients’ tumors must overproduce HER2 or have a HER2 mutation.
  • Patients may not have previously received trastuzumab or T-DM1.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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. Bob T. Li at 646-888-4201.

Protocol

18-528

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators