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Checkpoint Inhibitor

Stereotactic Radiosurgery for 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

STICk-IM-NSCLC Trial Summary

This trial is testing whether giving stereotactic radiosurgery at the same time as immune checkpoint inhibitor therapy is better than giving immune checkpoint inhibitor therapy alone in patients with non-small cell lung cancer that has spread to the brain.

Eligible Conditions

Non-Small Cell Lung Cancer
Brain Tumor

STICk-IM-NSCLC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intracranial progression free-survival

Secondary outcome measures

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

STICk-IM-NSCLC 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

2016

Completed Phase 2

~460

Immunotherapy

2016

Completed Phase 4

~1270

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,356 Previous Clinical Trials

3,418,994 Total Patients Enrolled

Jeffrey Clarke, MDPrincipal InvestigatorDuke Health

4 Previous Clinical Trials

109 Total Patients Enrolled

Scott Floyd, MD PhDPrincipal InvestigatorDuke Health

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study subjects are included in this research project?

"The information available on clinicaltrials.gov suggests that this study is still enrolling patients. This research was originally posted on September 1st, 2020 and was last updated June 6th, 2020. The trial is looking for 80 individuals at a single site."

Answered by AI

Are there any risks associated with Stereotactic Radiosurgery?

"Stereotactic Radiosurgery received a score of 2 from our analysts. This is due to the fact that, while there is data supporting its safety, none of the current clinical trials support efficacy claims."

Answered by AI

Are recruitment efforts for this clinical trial ongoing?

"That is correct, the trial listed on clinicaltrials.gov appears to be ongoing with the most recent update being on 6/6/2022. This study was originally posted on 9/1/2022 and is currently looking for 80 individuals at 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SRS Timing With Immune Checkpoint Inhibition in Patients With Untreated Brain Metastases From Non-small Cell Lung Cancer

2023. "SRS Timing With Immune Checkpoint Inhibition in Patients With Untreated Brain Metastases From Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04650490.