A Phase 1/2 Study of VS-6766 plus Adagrasib for People with Non-Small Cell Lung Cancer

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Full Title

A Phase 1/2 Study of Avutometinib in Combination with Adagrasib in Patients with KRAS G12C mutant Non-Small Cell Lung Cancer (NSCLC) (RAMP 204)

Purpose

The purpose of this study is to find the highest doses of the medications VS-6766 and adagrasib that can be given together in people with inoperable or metastatic non-small cell lung cancer (NSCLC) that contains a KRAS G12C gene mutation and got worse despite prior treatments. NSCLC sometimes progresses after treatment because the cancer develops new gene mutations.

Adagrasib blocks the KRAS G12C mutated protein, causing cancer cells to die. It may work better when given with VS-6766, which inhibits two other proteins that tell cancer cells to grow. Both drugs are taken orally (by mouth).

Who Can Join

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

  • Participants must have inoperable or metastatic NSCLC that contains a KRAS G12C gene mutation and has continued to grow despite at least one but no more than three prior regimens of standard treatments.
  • Patients must have received previous treatment with a KRAS G12C inhibitor.
  • At least 2 weeks must pass between the completion of previous treatments and receipt of the study therapy.
  • 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.

Contact

For more information about this study and to ask about eligibility, please contact Dr. Kathryn Arbour at 646-608-3792.

Protocol

22-417

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05375994