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PD-1 Inhibitor
Cemiplimab for Brain Metastasis from Lung Cancer
Phase 2
Recruiting
Led By Arya Amini
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 30 days prior to day 1 of protocol therapy)
Eastern Cooperative Oncology Group (ECOG) =< 1
Must not have
Has had prior chemotherapy or targeted small molecule therapy within 3 weeks prior to administration of the study drug or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent;
Unable or unwilling to undergo an intracranial MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a drug to help treat non-small cell lung cancer that has spread to the brain. It may delay the need for radiation and help the body's immune system attack the cancer.
Who is the study for?
This trial is for adults with non-small cell lung cancer (NSCLC) that has spread to the brain, and who have high levels of a protein called PD-L1. Participants must not have used immune checkpoint inhibitors before but can have had one cycle of chemotherapy. They should be in good physical condition (ECOG <= 1), able to understand English, and willing to use birth control. People are excluded if they've had certain other treatments or conditions, including specific gene mutations or severe autoimmune diseases.
What is being tested?
The trial is testing cemiplimab's effectiveness on untreated brain metastases from NSCLC without using upfront stereotactic radiosurgery or whole-brain radiation therapy. Cemiplimab is an immunotherapy drug designed to help the immune system fight cancer by interfering with tumor growth and spread.
What are the potential side effects?
Potential side effects of cemiplimab may include fatigue, skin reactions, joint pain, digestive issues like diarrhea or constipation, as well as possible inflammation-related symptoms affecting organs such as lungs or liver.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine clearance, is good.
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I am fully active and can carry on all pre-disease activities without restriction.
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My lung cancer is confirmed to be non-small cell type.
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I have never been treated with drugs targeting PD-1 or PD-L1.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had chemotherapy or targeted therapy in the last 3 weeks and have recovered from any side effects.
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I cannot or do not want to have a brain MRI.
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I had brain surgery more than 2 weeks ago, except for a biopsy.
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I have more than 10 brain metastases.
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I have had whole brain radiation before.
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I have cancer cells in the fluid around my brain and spinal cord.
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I am taking more than 4mg of dexamethasone daily or needed this dose for 3 days in a row within a week before starting treatment.
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My cancer does not have EGFR, ALK, or ROS1 mutations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Central nervous system (CNS) control rate
Secondary study objectives
Cumulative rate of best responses
Extracranial progression free survival
Incidence of adverse events
+5 moreAwards & 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: Treatment (Cemiplimab)Experimental Treatment5 Interventions
Patients receive cemiplimab IV and undergo blood sample collection while on study. Patients undergo MRI, CT scan and PET scan throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Cemiplimab
2015
Completed Phase 3
~1470
Computed Tomography
2017
Completed Phase 2
~2740
Positron Emission Tomography
2011
Completed Phase 2
~2200
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,971 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,546 Total Patients Enrolled
Arya AminiPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
284 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or targeted therapy in the last 3 weeks and have recovered from any side effects.Your liver enzyme levels are not more than 1.5 times the upper limit of normal.I cannot or do not want to have a brain MRI.I may have had one round of chemo for my current condition or had platinum-based chemo over 21 days ago.My kidney function, measured by creatinine clearance, is good.I had brain surgery more than 2 weeks ago, except for a biopsy.I have more than 10 brain metastases.I have another cancer, but it's either being treated, stable, or cured except for certain skin cancers or in situ cervical cancer.I am fully active and can carry on all pre-disease activities without restriction.I do not have severe autoimmune diseases except for stable hypothyroidism, vitiligo, or resolved childhood asthma.I haven't taken any monoclonal antibody treatments in the last 4 weeks or recovered from their side effects.I have had whole brain radiation before.I have cancer cells in the fluid around my brain and spinal cord.I am 18 years old or older.My lung cancer is confirmed to be non-small cell type.My bilirubin levels are within normal range, or I have Gilbert's disease.I am taking more than 4mg of dexamethasone daily or needed this dose for 3 days in a row within a week before starting treatment.I have a brain lesion near critical areas but it's treated and I meet other criteria.My cancer does not have EGFR, ALK, or ROS1 mutations.I have never been treated with drugs targeting PD-1 or PD-L1.My lung cancer does not have EGFR, ALK, or ROS mutations that can be treated with targeted therapy.I have up to 10 small brain lesions that don't affect my nervous system.Your liver function test results must show that your alanine aminotransferase (ALT) levels are no more than three times the upper limit of normal.My condition is in an advanced stage.You are not using corticosteroids to manage symptoms from your brain metastases, according to your doctor.Your PD-L1 level is 50% or higher.I am a woman who can have children and have a recent negative pregnancy test.I am capable of having children and have not been surgically sterilized.I have at least one untreated brain tumor between 5-15 mm, confirmed by a recent MRI.I have been off PD-1 or PD-L1 inhibitors for at least a year.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Cemiplimab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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