A Phase 3 Study of Olomorasib Plus Immunotherapy in People With Stage 2 or 3 Non-Small Cell Lung Cancer

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Full Title

A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination with Standard of Care Immunotherapy in Participants with Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer (SUNRAY-02)

Purpose

Researchers are assessing immunotherapy with or without olomorasib in people with non-small cell lung cancer (NSCLC). The people in this study have NSCLC that has already been treated with definitive therapy.

In addition, their cancers have a mutation (change) in the G12C location of the KRAS gene. Olomorasib may help slow or stop the growth of cancers with KRAS G12C mutations. It is taken orally (by mouth).

If your NSCLC was able to be surgically removed and you completed chemotherapy, you will be randomly assigned to get one of these treatments:

  • Pembrolizumab immunotherapy plus olomorasib
  • Pembrolizumab plus placebo (inactive drug)

If your NSCLC was treated with chemotherapy and radiation, you will be randomly assigned to get one of these treatments:

  • Durvalumab immunotherapy plus olomorasib
  • Durvalumab plus placebo

Who Can Join

To join this study, there are a few conditions. You must:

  • Have stage 2 or 3 NSCLC that was already treated with chemotherapy and either surgery or radiation therapy.
  • Have lung cancer with a KRAS G12C mutation.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Jamie Chaft’s office at 646-608-3761.

Protocol

25-167

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06890598