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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.

Must not have

Has received radiation therapy within 2 weeks of study drug administration.

Has active autoimmune disease that has required systemic treatment in the past 2 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy within the last 2 weeks.

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I have an autoimmune disease treated within the last 2 years.

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I have been treated with anti-PD1/PD-L1 or anti-CTLA4 therapy before.

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I have an active tuberculosis infection.

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I have had lung inflammation treated with steroids or currently have it.

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I have been diagnosed with interstitial lung disease.

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I am currently being treated for an infection.

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I do not have active Hepatitis B or C.

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I have an immune system disorder or am taking more than 10mg of prednisone daily.

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I've had radiation therapy before in the area where SBRT is planned.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Number of serious adverse events

Secondary study objectives

Measure of peripheral blood cell T cell levels

Number of adverse events of grade 3-4 or higher

Quantification of T cell receptor

+5 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: 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

2015

Completed Phase 3

~4010

Stereotactic body radiation therapy

2017

Completed Phase 1

~30