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Checkpoint Inhibitor

Combination Therapy for Non-Small Cell Lung Cancer

Phase 2
Recruiting
Led By Christopher G Azzoli, MD
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients
Pathologically confirmed NSCLC
Must not have
No prior history of thoracic radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from beginning of study treatment to approximately day 49-63 on study.
Awards & highlights

Summary

This trial will test a combination of therapies for stage IB-III non-small cell lung cancer. If successful, it could become a new standard of care for this disease.

Who is the study for?
This trial is for adults over 18 with operable stage IB-IIIB non-small cell lung cancer (NSCLC) who can undergo surgery. They must have good organ function, be able to tolerate lung resection, and not be pregnant or nursing. Participants need an ECOG Performance Status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.Check my eligibility
What is being tested?
The study tests a combination of pre-operative treatments: ipilimumab + nivolumab immunotherapies with low-dose stereotactic body radiation therapy (SBRT). It aims to see how well the cancer responds before surgery. The main goal is to measure the pathologic response after treatment.See study design
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs, skin rash, endocrine disorders like thyroid dysfunction, fatigue, gastrointestinal issues like diarrhea or colitis, and potential complications from radiation therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am postmenopausal or not pregnant if premenopausal.
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My lung cancer diagnosis was confirmed through a lab test.
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My lung cancer is at a stage where surgery can completely remove it.
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I am fully active or can carry out light work.
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My lungs are strong enough for surgery.
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I am older than 18 years.
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I understand the details of the clinical trial and can consent to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never had radiation therapy to the chest area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from beginning of study treatment to approximately day 49-63 on study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from beginning of study treatment to approximately day 49-63 on study. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients with a Pathologic Response
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Trial Design

1Treatment groups
Experimental Treatment
Group I: Protocol TherapyExperimental Treatment3 Interventions
Ipilimumab: 1mg/kg IV day 1. Nivolumab: 3mg/kg IV days 1, 15, 29. SBRT delivered as 1-2 fractions to the gross primary tumor and nodal disease following day 1 infusion and completed by day 3 (7Gy x 1; 4Gy x 2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2610
Nivolumab
2014
Completed Phase 3
~4740
SBRT
2014
Completed Phase 2
~1060

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
459 Previous Clinical Trials
559,332 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,724 Total Patients Enrolled
Christopher G Azzoli, MDPrincipal InvestigatorBrown University

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04933903 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Protocol Therapy
Non-Small Cell Lung Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04933903 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04933903 — Phase 2
~7 spots leftby Jul 2025
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