CompletedPhase 1 / Phase 2NCT05375994
Official study title

Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients

Study summary

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedavutometinib (VS-6766) and adagrasib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 2, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Verastem, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Verastem, Inc.
Interventions being studied
Drug: avutometinib (VS-6766) and adagrasib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Male or female subjects ≥ 18 years of age
  • Histologic or cytologic evidence of NSCLC
  • Known KRAS G12C mutation
  • The subject must have received prior therapy with a KRAS G12C inhibitor and experienced progression
  • Must have received appropriate treatment with at least one prior systemic regimen, but no more than 3 prior regimens, for Stage 3B-C or 4 NSCLC
  • Measurable disease according to RECIST 1.1
  • An Eastern Cooperative Group (ECOG) performance status ≤ 1
  • Adequate organ function
  • Adequate recovery from toxicities related to prior treatments
  • Agreement to use highly effective method of contraceptive
Reasons someone may not be able to joinExclusion criteria
  • Prior chemotherapy, targeted therapies, radiotherapy, immunotherapy or treatment with an investigational agent within 14 days of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C and chest radiation; within 6 months prior to Cycle 1 Day 1 for chest radiation \> 30Gy)
  • History of prior malignancy, with the exception of curatively treated malignancies
  • Major surgery within 4 weeks (excluding placement of vascular access)
  • Exposure to strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy
  • Exposure to strong inhibitors of breast cancer resistance protein (BCRP) within 14 days prior to the first dose and during the course of therapy
  • Symptomatic brain metastases requiring steroids or other local interventions within the 2 weeks prior to initiation of therapy
  • Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
  • Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active
  • Active skin disorder that has required systemic therapy within the past 1 year
  • History of rhabdomyolysis or interstitial lung disease
  • Concurrent ocular disorders
  • Concurrent heart disease or severe obstructive pulmonary disease
  • Subjects with the inability to swallow oral medications

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UCSF Thoracic OncologySan Francisco, California
  • University of Colorado Hospital Anschutz Cancer PavllionAurora, Colorado
  • Mayo Clinic Cancer CenterJacksonville, Florida
  • Mayo Clinic Cancer CenterRochester, Minnesota
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • University of North Carolina at Chapel HillChapel Hill, North Carolina
  • Virginia Cancer Specialists, NEXT OncologyFairfax, Virginia
  • Medical College WisconsinMilwaukee, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 2, 2026. Always confirm current availability with the study team.

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