ACTIVE_NOT_RECRUITING

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

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Conditions

Non Small Cell Lung CancerKRAS Activating MutationNSCLCKRAS G12C

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2 Study of Avutometinib (VS-6766) in Combination With Sotorasib With or Without Defactinib in Patients With KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC)

Quick Facts

Study Start:2022-04-12
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05074810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female patients ≥ 18 years of age
  2. * Histologic or cytologic evidence of NSCLC
  3. * Known KRAS G12C mutation
  4. * Either exposed or not exposed to a KRAS inhibitor to be included in Part A (avutometinib + sotorasib + defactinib) and not exposed to KRAS inhibitor to be included in Part B (avutometinib + sotorasib + defactinib), Cohort 1
  5. * Received at least 1 dose of a G12C inhibitor to be included in Part B, Cohort 2 (avutometinib + sotorasib + defactinib)
  6. * Must have received appropriate treatment with at least one prior systemic regimen, but no more than 2 prior regimens, for Stage 3B-C or 4 NSCLC
  7. * Measurable disease according to RECIST 1.1
  8. * An Eastern Cooperative Group (ECOG) performance status ≤ 1
  9. * Adequate organ function
  10. * Adequate recovery from toxicities related to prior treatments
  11. * Agreement to use highly effective method of contraceptive
  1. * Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
  2. * History of prior malignancy, with the exception of curatively treated malignancies
  3. * Major surgery within 4 weeks, minor surgery within 2 weeks (excluding placement of vascular access)
  4. * History of treatment with a direct and specific inhibitor of MEK
  5. * Exposure to strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy
  6. * Symptomatic brain metastases requiring steroids or other local interventions.
  7. * Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
  8. * Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active
  9. * Active skin disorder that has required systemic therapy within the past year
  10. * History of rhabdomyolysis
  11. * Concurrent ocular disorders
  12. * Concurrent heart disease or severe obstructive pulmonary disease
  13. * Inability to swallow oral medications
  14. * Female patients that are pregnant or breastfeeding
  15. * Previously treated with sotorasib and were dose reduced due to toxicity

Contacts and Locations

Principal Investigator

MD Verastem
STUDY_DIRECTOR
Verastem, Inc.

Study Locations (Sites)

Rocky Mountain Cancer Center, LLP
Boulder, Colorado, 80303
United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United States
MedStar Washington Hospital Center, MedStar Georgetown Cancer Institute,
Washington D.C., District of Columbia, 20010
United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
United States
Maryland Oncology & Hematology, P.A.
Rockville, Maryland, 20850
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Minnesota Oncology Hematology, P.A
Woodbury, Minnesota, 55125
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Ohio State University Brain and Spine Hospital
Columbus, Ohio, 43210
United States
Consultants in Medical Oncology & Hematology
Broomall, Pennsylvania, 19008
United States
Alliance Cancer Specialists,
Horsham, Pennsylvania, 19044
United States
Texas Oncology
Austin, Texas, 78731
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, 76104
United States
Texas Oncology
Longview, Texas, 75601
United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States
Northwest Cancer Specialists
Vancouver, Washington, 98684
United States

Collaborators and Investigators

Sponsor: Verastem, Inc.

  • MD Verastem, STUDY_DIRECTOR, Verastem, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-12
Study Completion Date2027-04

Study Record Updates

Study Start Date2022-04-12
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • NSCLC
  • KRAS G12C

Additional Relevant MeSH Terms

  • Non Small Cell Lung Cancer
  • KRAS Activating Mutation