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

ConditionsNon Small Cell Lung CancerNSCLCKRAS G12C
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Adagrasib

    Drug

    Adagrasib 600mg orally

  • Stereotactic Radiosurgery

    Radiation

    Delivered as per standard of care

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Adagrasib + SRS (Stereotactic Radiosurgery)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Intracranial disease control rate (DCR)

Intracranial disease control rate (DCR) \[complete response (CR) + partial response (PR) + stable disease (SD)\] per RECIST 1.1 for intracranial lesions at 3 months

Time frame
3 months

Secondary outcomes

1

Adverse events

Safety and tolerability will be assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).

Time frame
52 months
2

Intracranial overall response rate (ORR)

Intracranial overall response rate (icORR) will be measured by RECIST 1.1 criteria including only intracranial lesions. icORR is defined as the proportion of patients who have a partial or complete response (PR or CR) to therapy for intracranial lesions.

Time frame
52 months
3

Overall response rate (ORR)

ORR will be measured by RECIST 1.1. ORR is defined as the proportion of patients who have a partial or complete response to therapy for all disease (systemic and intracranial lesions).

Time frame
52 months
4

Progression free survival (PFS)

PFS is defined as time from the day of study treatment initiation until evidence of disease progression at any location per RECIST v1.1, or death from any cause.

Time frame
52 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ryan Gentzler, MD

Lead sponsor

Hoosier Cancer Research Network

Sponsor institution

Mirati Therapeutics Inc.

Collaborator

University of Virginia

Collaborator

Source ClinicalTrials.gov
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