Study on Avutometinib (VS-6766) and Adagrasib for Patients with KRAS G12C Non-Small Cell Lung Cancer

Sponsor: Verastem, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05375994

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment combining Avutometinib (VS-6766) and Adagrasib for patients with KRAS G12C Non-Small Cell Lung Cancer (NSCLC) who have previously been treated with a G12C inhibitor but their cancer has progressed.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if the combination of Avutometinib (VS-6766) and Adagrasib is safe and can help control cancer in patients with KRAS G12C Non-Small Cell Lung Cancer (NSCLC) who have already tried a G12C inhibitor and experienced disease progression. This study is being conducted at multiple centers and involves patients who meet specific criteria.

Description

This study is a Phase 1/2 trial, meaning it is in the early stages of testing a new treatment. It is not randomized, so all participants will receive the same treatment. The study is open-label, which means both the researchers and participants know what treatment is being given. The goal is to assess how safe and tolerable the combination of Avutometinib (VS-6766) and Adagrasib is, and to see if it can effectively treat KRAS G12C mutant Non-Small Cell Lung Cancer (NSCLC) in patients who have previously been treated with a G12C inhibitor and whose cancer has progressed. Participants will be closely monitored for any side effects and their response to the treatment will be evaluated.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC).
  • Have a known KRAS G12C mutation.
  • Must have previously been treated with a KRAS G12C inhibitor and experienced cancer progression.
  • Must have received at least one, but no more than three, prior treatments for advanced NSCLC.
  • Have measurable cancer according to specific medical criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function as determined by medical tests.
  • Have recovered from any side effects of previous treatments.
  • Agree to use a highly effective method of contraception during the study.

Exclusion Criteria

  • Have received chemotherapy, targeted therapies, radiotherapy, immunotherapy, or investigational treatments within 14 days before starting the study treatment (or longer for certain treatments).
  • Have a history of another cancer, unless it was treated and cured.
  • Have had major surgery within the past 4 weeks (except for minor procedures like placing a vascular access device).
  • Have taken certain medications that affect liver enzymes or breast cancer resistance protein within 14 days before starting the study treatment.
  • Have brain metastases that require treatment with steroids or other interventions within the past 2 weeks.
  • Have had a COVID-19 infection within 28 days before starting the study treatment.
  • Have active hepatitis B, hepatitis C, or HIV infections.
  • Have an active skin disorder that required treatment within the past year.
  • Have a history of muscle breakdown (rhabdomyolysis) or lung disease (interstitial lung disease).
  • Have current eye disorders.
  • Have current heart disease or severe lung disease (obstructive pulmonary disease).
  • Are unable to swallow pills.

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