An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease



Status:Not yet recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:September 14, 2019
End Date:March 14, 2024
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:ClinicalTrials@bms.com
Phone:please email:

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A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection

The purpose of this study is to determine if nivolumab added to the standard of care therapy
(SOC) given after surgery is more effective than SOC alone in prolonging disease free
survival in NSCLC participants with minimal residual disease detected after surgery.


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria prior to Surgery:

- Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is
considered resectable

- Must be deemed eligible for complete resection and must agree to undergo standard of
care surgery for complete resection of NSCLC

- Treatment naive (no previous systemic treatment)

Inclusion Criteria prior to Treatment Randomization:

- Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC

- Must have adequately recovered from surgery at the time of randomization

- Minimal residual disease (MRD) positive results as detected by ctDNA

Exclusion Criteria prior to Surgery:

- Participants with known EGFR mutations which are sensitive to available targeted
inhibitor therapy (Prior to treatment randomization in select sites)

- Active, known or suspected autoimmune disease

- Participants with a condition requiring systemic treatment with either corticosteroids
(> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14
days of randomization

Exclusion Criteria prior to Treatment Randomization:

- Must continue to meet Exclusion Criteria prior to Surgery

- Must have no evidence of metastatic disease after surgery

- Received a live/attenuated vaccine within 30 days of first treatment

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
6
sites
Lexington, Kentucky 40536
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Lexington, KY
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Charleston, South Carolina 29425
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Charleston, SC
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Gauting, 82131
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Gauting,
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Jacksonville, Florida 32256
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Jacksonville, FL
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Louisville, Kentucky 40202
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Louisville, KY
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Tyler, Texas 75702
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Tyler, TX
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