Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ryan Gentzler, MD
Study ID
NCT06248606
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adagrasib — DRUG
    Adagrasib 600mg orally
  • Stereotactic Radiosurgery — RADIATION
    Delivered as per standard of care

Study Details

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.

Key Dates

Start date
Aug 6, 2024
Status verified
Apr 2026
Primary completion
Feb 25, 2027
Completion
Feb 25, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adagrasib + SRS (Stereotactic Radiosurgery)
    All patients will receive oral adagrasib 600mg twice daily for every cycle and SRS which will be administered as standard of care. SRS will occur between 4 weeks prior to and up to 3 weeks after initiation of adagrasib. Patients may have received SRS prior to study enrollment. Cycle 1 Day 1 will begin on the first day of adagrasib dosing. Adagrasib should be held the day before and the day of SRS. There is no maximum duration of treatment.

Primary Outcome Measure

Intracranial disease control rate (DCR) [ Time Frame: 3 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Sarah Jewell
[email protected]
614-366-7421
Joshua Palmer, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Health SystemCharlottesvilleVirginia22908
Gracie Hockenberry, RN
[email protected]
Ryan Gentzler, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
Nicole Knight
[email protected]
804-828-5773
Mariza Daras, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Ohio State University Comprehensive Cancer Center· Columbus, OHUniversity of Virginia Health System· Charlottesville, VAVirginia Commonwealth University· Richmond, VA

Related Studies