Study Of VS-6766 + Adagrasib In KRAS G12C NSCLC Patients

Overview

About this study

The purpose of this study is to assess the safety and effectiveness of Avutometinib combined with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion 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.

Exclusion 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/25/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Yanyan Lou, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Kaushal Parikh, M.B.B.S.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions