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Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients

NCT05074810 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2026-01-12

No results posted yet for this study

Summary

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with sotorasib with or without defactinib in patients with KRAS G12C Non-Small Cell Lung Cancer (NSCLC) in patients who have been exposed to prior G12C inhibitor and those who have not been exposed to prior G12C inhibitor.

Conditions

  • Non Small Cell Lung Cancer
  • KRAS Activating Mutation

Interventions

DRUG

avutometinib and sotorasib

The RP2D of avutometinib + sotorasib determined in Part A will be used in Part B dose expansion

DRUG

avutometinib and sotorasib and defactinib

The RP2D of avutometinib + sotorasib + defactinib determined in Part A will be used in Part B dose expansion

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Verastem, Inc.

    lead INDUSTRY

Principal Investigators

  • MD Verastem · Verastem, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2026-06-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074810 on ClinicalTrials.gov