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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
ECOG Performance Status 0-1
Male patients must agree to use an adequate method of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from beginning of study treatment to approximately day 49-63 on study.
Awards & highlights
No Placebo-Only Group

Study 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 fully active or can carry out light work.
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I agree to use birth control during the study.
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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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My lung cancer diagnosis was confirmed through a lab test.
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My organs and bone marrow are working well.
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My lung cancer is at a stage where surgery can completely remove it.
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I have been checked by a lung surgeon before signing up.
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I understand the details of the clinical trial and can consent to participate.
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I am postmenopausal or not pregnant if premenopausal.

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]

Awards & 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: 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
~2690
Nivolumab
2014
Completed Phase 3
~4800
SBRT
2014
Completed Phase 2
~1020

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
450 Previous Clinical Trials
558,084 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,625 Previous Clinical Trials
4,119,003 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being asked to participate in this clinical trial?

"That is correct. As of February 22nd, 2022, this clinical trial was still recruiting patients that had first been posted about on October 5th, 2021. They are seeking 25 individuals from 1 medical location."

Answered by AI

What is the history of Ipilimumab in research?

"Ipilimumab is being researched in 796 clinical trials, 86 of which are currently active. The many Phase 3 studies for Ipilimumab primarily take place in Pittsburgh, Pennsylvania; however, there are 43300 locations running these sorts of trials."

Answered by AI

What are the conditions Ipilimumab is used to treat?

"Treatments that can be administered using Ipilimumab include anti-angiogenic therapy, malignant neoplasms, and unresectable melanoma."

Answered by AI

Are volunteers still being sought for this experiment?

"Based on the information available on clinicaltrials.gov, it appears that this study is still recruiting patients. The trial was first posted on 10/5/2021 and was last updated on 2/22/2022. They are looking for a total of 25 participants from 1 site."

Answered by AI

Could you explain the possible risks associated with Ipilimumab?

"While there is data supporting Ipilimumab's safety, it garnered a score of 2 because there is no evidence backing its efficacy."

Answered by AI
~7 spots leftby Feb 2025