Stereotactic Radiosurgery for Carcinoma, Non-Small-Cell Lung

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma, Non-Small-Cell Lung+5 More
Stereotactic Radiosurgery - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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
  • Carcinoma, Non-Small-Cell Lung
  • Brain
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: from randomization through study completion, an average of 3 years

1 year
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
Assess quality of life in each arm by the Functional Assessment of Cancer Therapy - Brain questionnaire
Year 3
Intracranial progression free-survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Immediate IO followed by SRS
1 of 2
Immediate SRS followed by IO
1 of 2

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Stereotactic Radiosurgery · No Placebo Group · Phase 2

Immediate IO followed by SRSExperimental Group · 2 Interventions: Stereotactic Radiosurgery, Immunotherapy · Intervention Types: Radiation, Drug
Immediate SRS followed by IOExperimental Group · 2 Interventions: Stereotactic Radiosurgery, Immunotherapy · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2012
Completed Phase 2
~320
Immunotherapy
2016
Completed Phase 4
~1020

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization through study completion, an average of 3 years

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,159 Previous Clinical Trials
3,188,498 Total Patients Enrolled
16 Trials studying Carcinoma, Non-Small-Cell Lung
592 Patients Enrolled for Carcinoma, Non-Small-Cell Lung
Jeffrey Clarke, MDPrincipal InvestigatorDuke Health
4 Previous Clinical Trials
102 Total Patients Enrolled
3 Trials studying Carcinoma, Non-Small-Cell Lung
99 Patients Enrolled for Carcinoma, Non-Small-Cell Lung
Scott Floyd, MD PhDPrincipal InvestigatorDuke Health
1 Previous Clinical Trials
20 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have adenocarcinoma of the lung.
Patient must have an MRI of the brain within 4 weeks (28 days) of signing the study consent.
You are female and/or male of childbearing potential.
Patient must be planned for immunotherapy treatment as their next systemic therapy, including monotherapy or in combination with chemotherapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.