Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRyan Gentzler, MD
About this trial
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.
Eligibility criteria
Qualifiers
Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
Confirmation of stage IV non-small cell lung cancer (NSCLC) per AJCC, 8th edition, or metastatic recurrence after treatment for earlier stage disease.
Disqualifiers
Prior treatment with KRAS G12C tyrosine kinase inhibitor.
Active infection requiring systemic therapy with the exception of #13 and #14 above.
Uncontrolled, significant intercurrent or recent illness.
Prolonged QTc interval > 480 milliseconds or history of congenital Long QT Syndrome
Trial design
Treatments tested in this trial
- Adagrasib
- Stereotactic Radiosurgery
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Ryan Gentzler, MD
Lead sponsor
Hoosier Cancer Research Network
Sponsor institution
Mirati Therapeutics Inc.
Collaborator
University of Virginia
Collaborator
Source ClinicalTrials.gov