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Checkpoint Inhibitor
Immunotherapy + Radiation for Advanced Lung Cancer (COSINR Trial)
Phase 1
Waitlist Available
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have measurable disease based on RECIST 1.1 including at least two metastatic lesions that meet criteria for SBRT radiation.
Have a performance status of 0 or 1 on the ECOG Performance Scale.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
COSINR Trial Summary
This trial is designed to study whether nivolumab/ipilimumab plus either sequential or concurrent stereotactic body radiotherapy (SBRT) is safe for patients with stage IV non-small cell lung cancer.
Who is the study for?
This trial is for adults over 18 with stage IV non-small cell lung cancer (NSCLC) who have good organ function and performance status. They must not be pregnant, agree to use birth control, and can't have had certain prior treatments like chemotherapy or immunotherapy for NSCLC. Patients with specific genetic mutations in their tumors must have tried targeted therapies first.Check my eligibility
What is being tested?
The study tests the safety of combining nivolumab/ipilimumab immunotherapy with stereotactic body radiotherapy (SBRT), either sequentially or at the same time. It aims to find a safe radiation dose and assess how these treatments affect the immune system within tumors across different locations in the body.See study design
What are the potential side effects?
Possible side effects include severe reactions related to SBRT and immunotherapy such as inflammation of organs, skin issues, hormonal imbalances, fatigue, digestive problems, potential worsening of autoimmune diseases, and increased risk of infections.
COSINR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread, and I have at least two tumors that can be measured and treated with targeted radiation.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lung cancer is at stage IV.
Select...
I am 18 years old or older.
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My cancer has worsened or I couldn't tolerate treatment despite having specific genetic changes.
COSINR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of serious adverse events
Secondary outcome measures
Measure of peripheral blood cell T cell levels
Number of adverse events of grade 3-4 or higher
Quantification of T cell receptor
+5 moreCOSINR Trial Design
2Treatment groups
Experimental Treatment
Group I: Sequential ArmExperimental Treatment3 Interventions
Patients will be randomized to either the Sequential Arm or the Concurrent Arm. Patients in the Sequential Arm will complete SBRT to 2-4 sites and then begin treatment with nivolumab/ipilimumab between 1-7 days after completion of SBRT.
Group II: Concurrent ArmExperimental Treatment3 Interventions
Patients will be randomized to either the Sequential Arm or the Concurrent Arm. Patients in the Concurrent Arm will begin treatment with nivolumab/ipilimumab first and must complete planned SBRT to 2-4 sites within 2 weeks (prior to second dose of nivolumab).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670
Stereotactic body radiation therapy
2017
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,001 Previous Clinical Trials
817,652 Total Patients Enrolled
Steven Chmura, MD, PhDStudy ChairUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been in a clinical trial for a new treatment or device in the last 4 weeks.You are allergic to nivolumab or ipilimumab.I have had radiation therapy within the last 2 weeks.I have another cancer besides skin or in situ cervical cancer that needs treatment.I have an autoimmune disease treated within the last 2 years.My cancer has spread, and I have at least two tumors that can be measured and treated with targeted radiation.I am willing to have repeat biopsies of my cancer before and after radiation.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with anti-PD1/PD-L1 or anti-CTLA4 therapy before.I have an active tuberculosis infection.I have brain metastases but am not on high doses of steroids.I have had lung inflammation treated with steroids or currently have it.I have taken a pregnancy test within 24 hours before my first dose of study medication and it was negative.I am using two birth control methods or am not having sex to avoid pregnancy during and 120 days after the study.I agree to use birth control during and for 4 months after the study.I have been diagnosed with interstitial lung disease.I am currently being treated for an infection.I do not have active Hepatitis B or C.I have not received a live vaccine in the last 30 days.My lung cancer is at stage IV.I am 18 years old or older.My cancer has worsened or I couldn't tolerate treatment despite having specific genetic changes.My recent tests show my organs are functioning well.I had chemotherapy for lung cancer, but not recent platinum-based treatment.I have an immune system disorder or am taking more than 10mg of prednisone daily.I've had radiation therapy before in the area where SBRT is planned.
Research Study Groups:
This trial has the following groups:- Group 1: Sequential Arm
- Group 2: Concurrent Arm
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been accepted into the scope of this research project?
"Affirmative. As per the clinicaltrials.gov data, this medical trial is currently enrolling patients. The study was first listed on September 7th 2017 and was updated most recently on February 8th 2022, with 80 participants sought from a single location."
Answered by AI
How reliable is Stereotactic body radiation therapy in terms of mitigating risks to patients?
"There has been little research on the safety of Stereotactic body radiation therapy, thus we assign it a score of 1."
Answered by AI
What other investigations have been led examining the efficacy of Stereotactic body radiation therapy?
"Currently, there are 764 experiments dedicated to exploring Stereotactic body radiation therapy; 86 of these trials have reached the advanced Phase 3 stage. While Pittsburgh, Pennsylvania is a major hub for research into this treatment option, 42751 other medical sites around the globe are conducting tests related to it."
Answered by AI
Is this clinical study accepting new participants?
"Affirmative. The clinical trial's information hosted on clinicaltrials.gov verifies that the study is still searching for patients, with a commencement date of September 7th 2017 and an update posted on February 8th 2022. 80 participants are needed from 1 site."
Answered by AI
What disease states are generally addressed by Stereotactic body radiation therapy?
"Stereotactic body radiation therapy is often used to supplement anti-angiogenic treatment, but can also be beneficial in treating issues such as maligant neoplasms, extensively spread melanoma and squamous cell carcinoma."
Answered by AI
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