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KRAS G12C Inhibitor

Adagrasib + SRS for Lung Cancer with Brain Metastases

Phase 2

Recruiting

Led By Ryan Gentzler, MD, MS

Research Sponsored by Ryan Gentzler, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmation of stage IV non-small cell lung cancer (NSCLC) per AJCC, 8th edition, or metastatic recurrence after treatment for earlier stage disease.

Presence of brain metastases that meet specific criteria as detailed in the protocol.

Must not have

Prior treatment with KRAS G12C tyrosine kinase inhibitor.

Prolonged QTc interval > 480 milliseconds or history of congenital Long QT Syndrome.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test the effectiveness of a combination treatment of SRS and adagrasib for patients with a specific type of lung cancer that has spread to the brain. 30 patients will participate in

Who is the study for?

This trial is for adults over 18 with stage IV non-small cell lung cancer (NSCLC) that has spread to the brain and have a specific mutation called KRAS G12C. They should be relatively healthy, able to perform daily activities with ease or minor difficulty, and have not treated their brain metastases yet. Up to 10 untreated brain tumors are allowed, but none larger than 3 cm.

What is being tested?

The study tests how well Adagrasib combined with Stereotactic Radiosurgery (SRS), which is a precise form of radiation therapy, works in treating NSCLC patients whose cancer has spread to the brain. All participants will receive this combination treatment.

What are the potential side effects?

Adagrasib may cause side effects like diarrhea, nausea, vomiting, fatigue and liver problems. SRS can lead to headaches, swelling around the treatment area in the brain causing neurological symptoms depending on location.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is at stage IV or has returned and spread after treatment.

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My cancer has spread to my brain, meeting specific study criteria.

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My cancer has a KRAS G12C mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a KRAS G12C inhibitor before.

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I have a long QT interval or a history of Long QT Syndrome.

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I must continue taking a medication that strongly affects liver enzyme CYP3A and cannot switch it.

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I am currently undergoing radiation therapy for pain management or prevention.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intracranial disease control rate (DCR)

Secondary study objectives

Adverse events

Intracranial overall response rate (ORR)

Intracranial progression free survival (PFS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adagrasib + SRS (Stereotactic Radiosurgery)Experimental Treatment2 Interventions

All patients will receive oral adagrasib 600mg twice daily for every cycle and SRS which will be administered as standard of care. Initiation of adagrasib and treatment with SRS will occur within 3 weeks of each other, in whichever order. 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adagrasib

2023

Completed Phase 1

~20

Stereotactic Radiosurgery

2021

Completed Phase 2

~440