Actively Recruiting
Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases
Led by Ryan Gentzler, MD · Updated on 2026-04-08
30
Participants Needed
3
Research Sites
185 weeks
Total Duration
On this page
Sponsors
R
Ryan Gentzler, MD
Lead Sponsor
M
Mirati Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single arm phase 2 trial is to evaluate the efficacy of SRS plus adagrasib for the treatment of brain metastases for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). A total of 30 patients will be enrolled on this study.
CONDITIONS
Official Title
Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization
- Be 18 years or older at consent
- Have an ECOG Performance Status of 0 or 1 within 28 days before registration
- Confirmed stage IV NSCLC or metastatic recurrence after earlier stage treatment
- Known KRAS G12C mutation confirmed by local tissue or ctDNA testing
- Have at least one untreated enhancing brain metastasis measuring at least 2 mm and no single metastasis larger than 3 cm
- Patients with surgically resected brain metastases may participate if additional brain metastases suitable for SRS exist
- Patients with progression of previously treated CNS metastases are eligible if solid lesion component has enlarged without radionecrosis concerns
- Patients who received SRS within 4 weeks before registration are eligible with prior baseline brain MRI
- Symptomatic brain metastases allowed if no cerebral herniation or symptomatic leptomeningeal disease, no seizures in past 14 days, and stable or improving neurologic symptoms on low-dose steroids
- CNS lesions must be treated with SRS within 3 weeks before treatment start or be suitable for SRS
- No contraindications to SRS; patients on anticoagulation must be able to hold medication for SRS
- May be treatment-naive or have received up to 2 prior systemic therapy lines
- Adequate organ function as defined by specific laboratory values within 28 days before registration
- Females of childbearing potential must have negative pregnancy test within 7 days before treatment
- Willingness to use contraception or abstain from heterosexual activity if sexually active and of childbearing potential
- HIV-infected patients on effective therapy with undetectable viral load within 6 months
- Patients with chronic hepatitis B or cured hepatitis C under specific viral load criteria
- Ability to understand and comply with study procedures for entire study duration
You will not qualify if you...
- Prior treatment with a KRAS G12C tyrosine kinase inhibitor
- Active infection requiring systemic therapy except for controlled HIV or hepatitis infections
- Uncontrolled or significant recent illness
- Prolonged QTc interval over 480 milliseconds or congenital Long QT Syndrome
- Currently receiving radiation to any extracranial lesion for prophylaxis or pain control
- Need for medications that strongly affect CYP3A enzyme and cannot be changed before study start
- Treatment with any investigational drug within 28 days before registration
- Pregnant or breastfeeding
- Prior or concurrent malignancy that might interfere with safety or efficacy assessments as judged by physician
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
2
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
3
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
R
Ryan Gentzler, MD, MS
CONTACT
A
Amber Ryba
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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