A Phase I Study of Ramucirumab or Necitumumab plus Osimertinib in Patients with Persistent Non-Small Cell Lung Cancer

Full Title

An Open-Label, Multicenter, Phase 1 Study with Expansion Cohorts of Ramucirumab or Necitumumab in Combination with Osimertinib in Patients with Advanced T790M-Positive EGFR-Mutant Non-Small Cell Lung Cancer after Progression on First-Line EGFR TKI Therapy

Purpose

Patients with non-small cell lung cancer (NSCLC) that contains an EGFR mutation typically receive EGFR inhibitors (such as erlotinib), but the cancer often becomes resistant to those drugs. In many patients, the resistance to EGFR inhibitors like erlotinib is due to an acquired mutation called EGFR T790M. Osimertinib is a newer EGFR inhibitor used to treat patients with NSCLC that has become resistant to other EGFR inhibitors and who have the EGFR T790M mutation.

In this study, researchers are evaluating different doses of two other drugs, ramucirumab and necitumumab, when given in combination with osimertinib in patients with T790M-positive EGFR-mutant NSCLC that has progressed after prior therapy with an EGFR inhibitor. Necitumumab is used to treat advanced squamous cell lung cancer; it also works by blocking EGFR. Ramucirumab inhibits the growth of the blood vessels that tumors need to grow and spread by blocking the activity of a protein called VEGFR2. It is approved to treat NSCLC when given in combination with chemotherapy.

In this study, patients will receive either ramucirumab plus osimertinib or necitumumab plus osimertinib. Ramucirumab and necitumumab are given intravenously (by vein), and osimertinib 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 locally advanced or metastatic NSCLC that has progressed despite EGFR inhibitor therapy (though not osimertinib or a monoclonal antibody).
  • Patients' tumors must be positive for the T790M EGFR mutation.
  • 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 and to inquire about eligibility for this study, please contact Dr. Helena Yu at 646-888-4274.

Protocol

16-876

Phase

I

Investigator

Co-Investigators