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An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

Primary Purpose

Stage IV or Recurrent Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Gemcitabine
Cisplatin
Carboplatin
Paclitaxel
Pemetrexed
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV or Recurrent Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
  • Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
  • PD-L1+ on immunohistochemistry testing performed by central lab
  • Men and women, ages ≥ 18 years of age

Exclusion Criteria:

  • Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy
  • Known anaplastic lymphoma kinase (ALK) translocations
  • Untreated central nervous system (CNS) metastases
  • Previous malignancies
  • Active, known or suspected autoimmune disease

Sites / Locations

  • Southern Cancer Center, Inc.
  • Banner MD Anderson Cancer Center
  • Local Institution - 0034
  • Local Institution - 0016
  • University Of Colorado Hosp
  • Local Institution - 0020
  • Local Institution - 0030
  • Local Institution - 0033
  • H. Lee Moffitt Cancer Center
  • Local Institution - 0010
  • Northwest Georgia Oncology Center, P.C.
  • Local Institution - 0037
  • Local Institution - 0014
  • Crescent City Research Consortium, LLC
  • Local Institution - 0024
  • Local Institution - 0036
  • Local Institution - 0070
  • Roswell Park Cancer Institute
  • Local Institution - 0009
  • Local Institution - 0005
  • University Of North Carolina At Chapel Hill
  • Local Institution - 0003
  • Local Institution - 0012
  • Local Institution - 0027
  • Oregon Health & Science University
  • Local Institution - 0007
  • Local Institution - 0054
  • Local Institution - 0002
  • Local Institution - 0018
  • Local Institution - 0011
  • Local Institution - 0038
  • Local Institution - 0008
  • Local Institution - 0006
  • Local Institution - 0023
  • Cancer Centers of South Texas
  • Local Institution - 0029
  • Local Institution - 0051
  • Local Institution - 0049
  • Local Institution - 0052
  • Local Institution - 0048
  • Local Institution - 0050
  • Local Institution - 0090
  • Local Institution - 0091
  • Local Institution - 0071
  • Local Institution - 0072
  • Local Institution - 0104
  • Local Institution - 0088
  • Local Institution - 0087
  • Local Institution - 0044
  • Local Institution - 0055
  • Local Institution - 0056
  • Local Institution - 0062
  • Local Institution - 0134
  • Local Institution - 0133
  • Local Institution - 0135
  • Local Institution - 0086
  • Local Institution - 0115
  • Local Institution - 0113
  • Local Institution - 0110
  • Local Institution - 0109
  • Local Institution - 0059
  • Local Institution - 0061
  • Local Institution - 0058
  • Local Institution - 0060
  • Local Institution - 0120
  • Local Institution - 0119
  • Local Institution - 0118
  • Local Institution - 0123
  • Local Institution - 0105
  • Local Institution - 0102
  • Local Institution - 0167
  • Local Institution - 0100
  • Local Institution - 0140
  • Local Institution - 0074
  • Local Institution - 0065
  • Local Institution - 0064
  • Local Institution - 0063
  • Local Institution - 0066
  • Local Institution - 0092
  • Local Institution - 0073
  • Local Institution - 0075
  • Local Institution - 0126
  • Local Institution - 0116
  • Local Institution - 0094
  • Local Institution - 0084
  • Local Institution - 0079
  • Local Institution - 0143
  • Local Institution - 0142
  • Local Institution - 0083
  • Local Institution - 0082
  • Local Institution - 0161
  • Local Institution - 0146
  • Local Institution - 0148
  • Local Institution - 0153
  • Local Institution - 0144
  • Local Institution - 0151
  • Local Institution - 0166
  • Local Institution - 0147
  • Local Institution - 0145
  • Local Institution - 0152
  • Local Institution - 0150
  • Local Institution - 0149
  • Local Institution - 0154
  • Local Institution - 0159
  • Local Institution - 0162
  • Local Institution - 0165
  • Local Institution - 0160
  • Local Institution - 0158
  • Local Institution - 0155
  • Local Institution - 0164
  • Local Institution - 0163
  • Local Institution - 0117
  • Local Institution - 0122
  • Local Institution - 0124
  • Local Institution - 0045
  • Local Institution - 0057
  • Local Institution - 0046
  • Local Institution - 0114
  • Local Institution - 0131
  • Local Institution - 0139
  • Local Institution - 0089
  • Local Institution - 0093
  • Local Institution - 0068
  • Local Institution - 0067
  • Local Institution - 0069
  • Local Institution - 0040
  • Local Institution - 0041
  • Local Institution - 0047
  • Local Institution - 0042
  • Local Institution - 0039
  • Local Institution - 0043
  • Local Institution - 0127
  • Local Institution - 0125
  • Local Institution - 0076
  • Local Institution - 0077
  • Local Institution - 0078
  • Local Institution - 0157
  • Local Institution - 0130
  • Local Institution - 0098
  • Local Institution - 0097
  • Local Institution - 0053

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Nivolumab subjects

Arm B: Investigator's Choice Chemotherapy

Arm Description

Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure

Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first Squamous subjects: Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle Non-Squamous subjects: Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle Optional crossover: Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure

Outcomes

Primary Outcome Measures

Progression-Free Survival in Participants With PD-L1 Expression >= 5%
Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.

Secondary Outcome Measures

Progression-Free Survival in All Randomized Participants
Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
Overall Survival in Participants With PD-L1 Expression >= 5%
Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
Overall Survival in All Randomized Participants
Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.
Disease-related Symptom Improvement Rate by Week 12
The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.

Full Information

First Posted
January 19, 2014
Last Updated
February 2, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02041533
Brief Title
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Official Title
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2014 (Actual)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV or Recurrent Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
541 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Nivolumab subjects
Arm Type
Experimental
Arm Description
Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure
Arm Title
Arm B: Investigator's Choice Chemotherapy
Arm Type
Active Comparator
Arm Description
Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first Squamous subjects: Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle Non-Squamous subjects: Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle Optional crossover: Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, MDX-1106
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Primary Outcome Measure Information:
Title
Progression-Free Survival in Participants With PD-L1 Expression >= 5%
Description
Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
Time Frame
From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Secondary Outcome Measure Information:
Title
Progression-Free Survival in All Randomized Participants
Description
Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
Time Frame
From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Title
Overall Survival in Participants With PD-L1 Expression >= 5%
Description
Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
Time Frame
From date of randomization to date of death (up to approximately 89 months)
Title
Overall Survival in All Randomized Participants
Description
Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
Time Frame
From date of randomization to date of death (up to approximately 89 months)
Title
Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
Description
ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.
Time Frame
From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)
Title
Disease-related Symptom Improvement Rate by Week 12
Description
The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.
Time Frame
From date of randomization to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1 Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria PD-L1+ on immunohistochemistry testing performed by central lab Men and women, ages ≥ 18 years of age Exclusion Criteria: Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy Known anaplastic lymphoma kinase (ALK) translocations Untreated central nervous system (CNS) metastases Previous malignancies Active, known or suspected autoimmune disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Southern Cancer Center, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Local Institution - 0034
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Local Institution - 0016
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5826
Country
United States
Facility Name
University Of Colorado Hosp
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0020
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Local Institution - 0030
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Local Institution - 0033
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Local Institution - 0010
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwest Georgia Oncology Center, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Local Institution - 0037
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3841
Country
United States
Facility Name
Local Institution - 0014
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Crescent City Research Consortium, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Local Institution - 0024
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Local Institution - 0036
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution - 0070
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Local Institution - 0009
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 0005
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University Of North Carolina At Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7305
Country
United States
Facility Name
Local Institution - 0003
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution - 0012
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Local Institution - 0027
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Local Institution - 0007
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Local Institution - 0054
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution - 0002
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Local Institution - 0018
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Local Institution - 0011
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0038
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Local Institution - 0008
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Local Institution - 0006
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Local Institution - 0023
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Local Institution - 0029
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Local Institution - 0051
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
1880
Country
Argentina
Facility Name
Local Institution - 0049
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0052
City
Ciudad Autonoma De Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Local Institution - 0048
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0050
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0090
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution - 0091
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution - 0071
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Local Institution - 0072
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Local Institution - 0104
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 0088
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Local Institution - 0087
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0044
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution - 0055
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Local Institution - 0056
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0062
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0134
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution - 0133
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Local Institution - 0135
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14780-070
Country
Brazil
Facility Name
Local Institution - 0086
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Local Institution - 0115
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Local Institution - 0113
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution - 0110
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Local Institution - 0109
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Local Institution - 0059
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Local Institution - 0061
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Local Institution - 0058
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Local Institution - 0060
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Local Institution - 0120
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Local Institution - 0119
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Local Institution - 0118
City
Vaasa
ZIP/Postal Code
65130
Country
Finland
Facility Name
Local Institution - 0123
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Local Institution - 0105
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Local Institution - 0102
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Local Institution - 0167
City
Pontoise Cedex
ZIP/Postal Code
95303
Country
France
Facility Name
Local Institution - 0100
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution - 0140
City
Strasbourg
ZIP/Postal Code
67090
Country
France
Facility Name
Local Institution - 0074
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Local Institution - 0065
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Local Institution - 0064
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Local Institution - 0063
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution - 0066
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Local Institution - 0092
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Local Institution - 0073
City
Heraklion
State/Province
Creta
ZIP/Postal Code
71110
Country
Greece
Facility Name
Local Institution - 0075
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Local Institution - 0126
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Local Institution - 0116
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Local Institution - 0094
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Local Institution - 0084
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Local Institution - 0079
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Facility Name
Local Institution - 0143
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution - 0142
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0083
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Local Institution - 0082
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Local Institution - 0161
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4640021
Country
Japan
Facility Name
Local Institution - 0146
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4600001
Country
Japan
Facility Name
Local Institution - 0148
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
7910280
Country
Japan
Facility Name
Local Institution - 0153
City
Kobe City
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
Facility Name
Local Institution - 0144
City
Natori-shi
State/Province
Miyagi
ZIP/Postal Code
9811293
Country
Japan
Facility Name
Local Institution - 0151
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Local Institution - 0166
City
Habikino-shi
State/Province
Osaka
ZIP/Postal Code
5638588
Country
Japan
Facility Name
Local Institution - 0147
City
Miyakojima-ku
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Local Institution - 0145
City
Osaka-sayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Local Institution - 0152
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Local Institution - 0150
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
3620806
Country
Japan
Facility Name
Local Institution - 0149
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
4118777
Country
Japan
Facility Name
Local Institution - 0154
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
Local Institution - 0159
City
Akashi, Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Local Institution - 0162
City
Ota, Gunma
ZIP/Postal Code
3738550
Country
Japan
Facility Name
Local Institution - 0165
City
Sapporo, Hokkaido
ZIP/Postal Code
062-0931
Country
Japan
Facility Name
Local Institution - 0160
City
Tokyo
ZIP/Postal Code
1358550
Country
Japan
Facility Name
Local Institution - 0158
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Local Institution - 0155
City
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 0164
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution - 0163
City
Seoul
ZIP/Postal Code
0
Country
Korea, Republic of
Facility Name
Local Institution - 0117
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution - 0122
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Local Institution - 0124
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97133
Country
Mexico
Facility Name
Local Institution - 0045
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Local Institution - 0057
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
Facility Name
Local Institution - 0046
City
Rotterdam
ZIP/Postal Code
3014 GD
Country
Netherlands
Facility Name
Local Institution - 0114
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Local Institution - 0131
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Local Institution - 0139
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Local Institution - 0089
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0093
City
Wodzislaw Slaski
ZIP/Postal Code
44-300
Country
Poland
Facility Name
Local Institution - 0068
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution - 0067
City
Cluj-napoca
ZIP/Postal Code
400352
Country
Romania
Facility Name
Local Institution - 0069
City
Ploiesti
ZIP/Postal Code
100337
Country
Romania
Facility Name
Local Institution - 0040
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0041
City
Las Palmas De Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Local Institution - 0047
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Local Institution - 0042
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 0039
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution - 0043
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Local Institution - 0127
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Local Institution - 0125
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Local Institution - 0076
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Local Institution - 0077
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Local Institution - 0078
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution - 0157
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Local Institution - 0130
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Local Institution - 0098
City
London
State/Province
Greater London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Local Institution - 0097
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4XB
Country
United Kingdom
Facility Name
Local Institution - 0053
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28636851
Citation
Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

Learn more about this trial

An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

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