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Checkpoint Inhibitor

SRS Timing With Immune Checkpoint Inhibition in Patients With Untreated Brain Metastases From Non-small Cell Lung Cancer (STICk-IM-NSCLC Trial)

Phase 2

Waitlist Available

Led By Jeffrey Clarke, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization through study completion, an average of 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how the timing of precise brain radiation and immune-boosting therapy affects patients with lung cancer that has spread to the brain.

Eligible Conditions

Non-Small Cell Lung Cancer
Brain Tumor

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization through study completion, an average of 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization through study completion, an average of 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization through study completion, an average of 3 years 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 progression free-survival

Secondary study objectives

Assess neurocognitive outcome in each arm by the Controlled Oral Word Association test

Assess neurocognitive outcome in each arm by the Hopkins Verbal Learning Test - Revised

Assess neurocognitive outcome in each arm by the Trail Making Test Parts A and B

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Immediate SRS followed by IOExperimental Treatment2 Interventions

Participants will receive SRS followed by physician's choice of standard of care immunotherapy, given at the FDA-approved dose within 14 days of SRS.

Group II: Immediate IO followed by SRSExperimental Treatment2 Interventions

Participants will receive physician's choice of immunotherapy, given at the FDA-approved dose followed by SRS, if deemed appropriate, at the time of intracranial progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiosurgery

2021

Completed Phase 2

~440

Immunotherapy

2016

Completed Phase 4

~1530