A Phase I Study of Patritumab Deruxtecan in Combination with Osimertinib in People with Advanced Non-Small Cell Lung Cancer with an EGFR Mutation

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Full Title

A Phase 1 Open-Label Study of Patritumab Deruxtecan (U3-1402) in Combination with Osimertinib in Subjects with Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC)

Purpose

Patritumab deruxtecan (U3-1402) is an investigational drug that attaches to cancer cells that produce a protein called HER3 and kills them. Researchers think that patritumab deruxtecan, given in combination with a drug called osimertinib, may be an effective treatment for people with advanced non-small cell lung cancer (NSCLC) with an EGFR mutation and which produces HER3.

Osimertinib is a standard treatment for metastatic NSCLC that has an EGFR gene mutation. Over time, some people develop resistance to osimertinib, and combining osimertinib with other anticancer medications may prevent or delay the development of this resistance. In this study, researchers want to find the highest dose of patritumab deruxtecan that can be given in combination with osimertinib in patients with advanced NSCLC.

Eligibility

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

  • Patients must have locally advanced or metastatic NSCLC containing an EGFR mutation (exon 19 deletion or L858R) and experienced continued cancer growth during or after initial treatment with osimertinib.
  • Patients may not have received any medical treatment other than osimertinib for advanced lung cancer.
  • 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 and to inquire about eligibility for this study, please contact Dr. Helena Yu at 646-608-3912.

Protocol

21-132

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators