A Phase I Study of RO5126766 for Patients with Advanced KRAS-Mutant Lung Cancer

Full Title

A Phase 1 Trial of RO5126766 (CH5126766) in Patients with Advanced KRAS-Mutant Lung Adenocarcinomas

Purpose

The purpose of this study is to find the highest dose of the investigational drug RO5126766 that can be given safely in patients with advanced non-small cell lung cancer (NSCLC) that continues to grow despite prior immunotherapy and contains a mutation called KRAS.

RO5126766 blocks two types of proteins in the body: RAF and MEK. In people with KRAS-mutant lung cancer, RAF and MEK make their cancer cells grow faster than normal, healthy cells. There are drugs that block either RAF or MEK alone, but RO5126766 blocks both of these proteins at the same time. Researchers think that this “double hit” will cause mutated cancer cells to die.

RO5126766 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 advanced KRAS-mutated NSCLC that continues to grow despite prior treatment that included anti-PD-1 or PD-L1 immunotherapy as well as chemotherapy.
  • At least 3 weeks must pass since the completion of chemotherapy and 2 weeks since the completion of any radiation therapy and entry into the study.
  • Patients may not have previously received RAF or MEK inhibiting drugs.
  • 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 about this study and to inquire about eligibility, please contact Dr. Gregory Riely at 646-888-4199.

Protocol

18-285

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators