Adagrasib and Radiation for Lung Cancer with Brain Metastases
This study is for people with non-small cell lung cancer (NSCLC) that has spread to the brain and has a specific genetic change called KRAS G12C. It is testing a combination of two treatments: adagrasib (a drug taken by mouth) and stereotactic radiosurgery (SRS), a type of focused radiation. The goal is to see how well this combination controls the cancer in the brain. Researchers will measure this control after 3 months. You may be able to join if you are 18 or older and meet certain health criteria. The study plans to enroll 30 patients.
- Study design
- This is a single-arm Phase 2 study, meaning all 30 participants will receive the same treatment combination. There is no comparison group.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, intracranial disease control, will be measured at 3 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06248606
Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases
Recruiting
PHASE2Ages 18+InterventionalTreatmentRyan Gentzler, MDInvestigator-initiated
~30 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:AdagrasibStereotactic Radiosurgery
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intracranial disease control rate (DCR)
Measured over 3 months
Conditions
Where it's being run
3 sites across 2 statesVirginia2
Ohio1
Study leadership
- Ryan Gentzler, MD, MS · PRINCIPAL_INVESTIGATOR · University of Virginia
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must have at least 1 untreated enhancing intracranial lesion, per local radiology interpretation, measuring at least 2mm. NOTE: intracranial lesions do not need to be measurable by RECIST 1.1 criteria to be eligible.
Must have no single metastasis measuring larger than 3 cm.
Patients with surgically resected brain metastases are eligible provided there are additional brain metastases amenable to SRS
Patients with progression of previously radiated or surgically resected CNS metastases are eligible if solid component of lesion has enlarged and there is no concern for radionecrosis based on investigator discretion.
Patients who received SRS within 4 weeks prior to registration are eligible provided baseline brain MRI prior to SRS treatment is within 4 weeks of study registration and SRS treatment meets requirements in #7 below.
Symptomatic brain metastases are permitted if the following criteria are met:
No evidence of cerebral herniation or symptomatic leptomeningeal disease
No seizures within past 14 days; antiepileptic medications are permitted
Patients on steroids must have stable or improving neurologic symptoms that have not worsened during a steroid taper. Must be receiving the equivalent of dexamethasone 8 mg total daily dose or less at the time of registration. 7. CNS lesions have already been treated with SRS (within 3 weeks prior to Cycle 1 Day 1) or are amenable to SRS as determined by radiation oncologist and/or neurosurgeon. SRS treatment must use GammaKnife or linear accelerator-based treatments with nominal x-ray energy of 6MV or greater. 8. No contraindications to SRS. Patients on anticoagulation must be able to hold anticoagulation for SRS treatment based on investigator discretion. 9. Patients may be treatment-naïve OR have received up to 2 prior lines of systemic therapy. Treatment with systemic therapy for Stage I-III disease \> 12 months prior to development of metastases do not count as a line of therapy. Treatment with platinum-doublet chemotherapy and checkpoint inhibitor immunotherapy (PD-1, PD-L1, CTLA-4, etc.) either in combination or sequentially counts as one line of therapy. 10. Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.
Hemoglobin (Hgb): ≥ 8.0 g/dL in the absence of transfusions within 7 days prior to testing.
Calculated creatinine clearance: ≥ 60 mL/min
Bilirubin: ≤ 1.5 mg/dL
Aspartate aminotransferase (AST): ≤ 3.0 × ULN
Alanine aminotransferase (ALT): ≤ 3.0 × ULN 11. Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment initiation. 12. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception. Males able to father a child who are sexually active with female of childbearing potential must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception. 13. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial. Testing is not required at screening unless mandated by local policy. 14. Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Testing is not required at screening unless mandated by local policy. 15. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
What this trial measures
- Intracranial disease control rate (DCR)3 months
Intracranial disease control rate (DCR) \[complete response (CR) + partial response (PR) + stable disease (SD)\] per RECIST 1.1 for intracranial lesions at 3 months