A Pilot Study of Dacomitinib in Patients with Metastatic EGFR-Mutant Lung Cancer Previously Treated with Osimertinib

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A Pilot Study of Dacomitinib for Patients with Metastatic EGFR Mutant Lung Cancers with Disease Progression on Osimertinib

Purpose

Patients with non-small cell lung cancer (NSCLC) that contains a mutation in the EGFR gene typically receive EGFR inhibitors (such as erlotinib), but the cancer often becomes resistant to those drugs. Osimertinib is a newer EGFR inhibitor used to treat NSCLC that has become resistant to other EGFR inhibitors. However, in some patients osimertinib may stop working, and the cancer begins to grow again.

The purpose of this study is to see if the drug dacomitinib is effective against metastatic EGFR-mutant NSCLC that has continued to grow despite osimertinib treatment. There are no approved targeted treatment options for patients whose disease has gotten worse after treatment with osimertinib. Dacomitinib is approved by the U.S. Food and Drug Administration for the initial treatment of patients with metastatic NSCLC that has certain EGFR mutations. It is taken orally (by mouth).

Eligibility

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

  • Patients must have metastatic EGFR-mutant NSCLC that has continued to grow despite first-line treatment with osimertinib.
  • Patients may not have previously received gefitinib, afatinib, or erlotinib.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • 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 646-888-4274.

Protocol

18-341

Phase

Pilot

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators