A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety of patients in Asia with Non-Small Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third line treatment.

Official Title
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An Open Label, Safety Study of Participants With Non-Small Cell Lung Cancer Receiving Second-Line Nivolumab Monotherapy in Asia

Conditions
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Lung Cancer, Non-Small Cell Lung Cancer

Intervention / Treatment
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* Biological: Nivolumab


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Advanced metastatic stage IIIB/IV NSCLC (Nonsquamous and squamous) 1 to 2 prior systemic therapies Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1 Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment Exclusion Criteria: Women with a positive pregnancy test at enrollment or prior to administration of study medication Participants with active central nervous system metastases Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period Participants with carcinomatous meningitis Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monotherapy<br>Nivolumab administered every two weeks | Biological: Nivolumab<br>* Intravenous infusion administered over 30 minutes at 240 mg<br>* Other names: BMS-936558;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of high grade treatment-related select adverse events in non-hepatitis B virus (HBV) infected participants | Measured by number of incidences | Approximately 2 years | 
| Severity of high grade treatment-related select adverse events in non-HBV infected participants | Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4) | Approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of high grade treatment-related select adverse events in HBV infected participants | Measured by number of incidences | Approximately 2 years | 
| Severity of high grade treatment-related select adverse events in HBV infected participants | Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4) | Approximately 2 years | 
| Laboratory test abnormalities | Measured by laboratory test parameters | Approximately 2 years | 
| Incidence of adverse events in all treated patients | Measured by number of incidences | Approximately 2 years | 
| Severity of adverse events in all treated patients | Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4) | Approximately 2 years |