Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18 - 75
Trial acronym
CheckMate 227
Clinical summary
Summary
The purpose of this study is to show that Nivolumab or Nivolumab plus ipilimumab, improves progression free survival and/or overall survival compared with chemotherapy in subjects advanced lung cancer. **Patients must have programmed death-ligand 1 (PD-L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period**
Conditions
This trial is treating people with Non-Small Cell Lung Cancer
Eligibility
Inclusion
- Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
- Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
- Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
Exclusion
- Subjects with untreated Central nervous system (CNS) metastases are excluded
- Subjects with an active, known or suspected autoimmune disease are excluded
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Bristol-Myers Squibb (BMS)
Scientific Title
An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
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