A Phase I Study of Dacomitinib and Osimertinib for Patients with Advanced EGFR-Mutant Lung Cancer

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Phase 1 Study of Combination Dacomitinib and Osimertinib for Patients with Metastatic EGFR Mutant Lung Cancers

Purpose

Patients with non-small cell lung cancer (NSCLC) that contains a mutation in the EGFR gene typically receive EGFR inhibitors, but the cancer often becomes resistant to those drugs. One of the ways cancers become resistant to this treatment is by developing additional EGFR mutations that make certain EGFR inhibitors ineffective, particularly older drugs such as erlotinib.

Osimertinib and dacomitinib are newer EGFR inhibitors each approved as initial treatment for NSCLC that has certain EGFR mutations. Researchers want to know if giving osimertinib and dacomitinib together may be more effective than using either one alone. The rationale is that these drugs, when used in combination, may be able to prevent certain mutations from forming that make the cancer resistant to treatment. The purpose of this study is to find the highest doses of dacomitinib and osimertinib that can be given together safely in patients with metastatic NSCLC who have not yet received EGFR inhibitor therapy. Both drugs are 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 EGFR-mutant NSCLC that has not previously been treated with an EGFR inhibitor.
  • 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 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Helena Yu at 646-888-4274.

Protocol

18-411

Phase

I

Investigator

Co-Investigators