A Phase IB/II Study of ERAS-007 plus Osimertinib in People with Non-Small Cell Lung Cancer

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Full Title

Phase 1b/2, Open-Label, Multicenter Study of ERAS-007 in Combination with Other Anti-Cancer Therapies in Patients with Advanced Non-Small-Cell Lung Cancer (HERKULES-2)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug ERAS-007 given with osimertinib in people with advanced non-small cell lung cancer (NSCLC) that contains an EGFR gene mutation.

Osimertinib is a standard treatment for NSCLC with an EGFR mutation, but sometimes the cancer continues to grow. Researchers believe a protein called ERK may be responsible for the resistance that NSCLC develops to osimertinib. ERAS-007 works by blocking ERK; it is hoped that giving it in combination with osimertinib may be more effective against cancer than osimertinib alone.

People in this study will take osimertinib every day and ERAS-007 either once or twice a day. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have NSCLC that has spread beyond the lungs and contains an EGFR mutation.
  • Patients may not have previously received medications that inhibit the ERK, RAS, RAF, or MEK proteins.
  • At least 3 weeks must pass between the completion of prior treatment and receipt of the study therapy. People taking osimertinib, however, can continue taking it.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Helena Yu at 646-608-3912.

Protocol

21-492

Phase

I/II

Investigator

Co-Investigators