For Healthcare Professionals

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

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About the study

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
  2. Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
  4. Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Subjects with untreated Central nervous system (CNS) metastases are excluded
  2. Subjects with an active, known or suspected autoimmune disease are excluded
  3. Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection

Other protocol defined inclusion/exclusion criteria apply


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Non-Small Cell Lung Cancer

Age (in years)

18+

Phase

Phase 3

Participants needed

2748

Est. Completion Date

Aug 30, 2024

Treatment type

Interventional


Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT02477826

Study number

CA209227

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