Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 21.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: LLT Classification code 10025048 Term: Lung cancer non-small cell recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy - Subjects must have PD-L1 IHC testing, with results, performed by the central lab during the screening period - ECOG Performance Status of ==65 years) yes F.1.3.1 Number of subjects for this age range 575
Exclusion criteria
Exclusion criteria: - Subjects with untreated 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to show that nivolumab or nivolumab plus ipilimumab or nivolumab plus chemotherapy, improves progression free survival and/or overall survival compared with chemotherapy in subjects with advanced lung cancer. See also section 1.4 of the protocol;Secondary Objective: - To compare the objective response rate (ORR) assessment, overall survival and/or progression free survival of nivolumab monotherapy and/or nivolumab in combination with ipilimumab and/or nivolumab in combination with platinum-doublet chemotherapy to platinum-doublet chemotherapy in subjects with advanced lung cancer. See also section 1.4 of the protocol;Primary end point(s): In Part 1 the co-primary objectives will be measured by OS and PFS assessed by BICR. In Part 2 the primary endpoint is OS. The definitions for OS and PFS are described in Section 8.3.1 of the protocol.;Timepoint(s) of evaluation of this end point: PFS Time Frame: 25 months from randomization of the first subject OS Time Frame: 40 months from randomization of the first subject (25 months for part 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - OS and PFS are also used to evaluate secondary objectives in Part 1 and Part 2. - ORR (see definition in section 8.3.2. of the protocol) -Time to Response and Duration of Response are secondary endpoints to support ORR endpoint (see definition in section 8.3.2. of the protocol);Timepoint(s) of evaluation of this end point: - Same timepoints as for OS and PFS | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed