History of Changes for Study: NCT02041533

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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Study Record Versions

Version	Submitted Date	Changes
1	January 19, 2014	None (earliest Version on record)
2	February 28, 2014	Study Status
3	March 26, 2014	Recruitment Status, Study Status and Contacts/Locations
4	April 29, 2014	Contacts/Locations, Study Status and References
5	May 7, 2014	Contacts/Locations and Study Status
6	May 27, 2014	Contacts/Locations and Study Status
7	May 30, 2014	Study Status
8	July 4, 2014	Contacts/Locations and Study Status
9	July 9, 2014	Contacts/Locations and Study Status
10	July 23, 2014	Contacts/Locations and Study Status
11	August 11, 2014	Contacts/Locations and Study Status
12	August 28, 2014	Contacts/Locations and Study Status
13	September 15, 2014	Contacts/Locations and Study Status
14	September 22, 2014	Contacts/Locations and Study Status
15	October 13, 2014	Contacts/Locations and Study Status
16	October 30, 2014	Contacts/Locations and Study Status
17	November 13, 2014	Contacts/Locations and Study Status
18	November 20, 2014	Contacts/Locations and Study Status
19	December 5, 2014	Contacts/Locations and Study Status
20	December 31, 2014	Contacts/Locations and Study Status
21	January 27, 2015	Contacts/Locations and Study Status
22	February 26, 2015	Contacts/Locations, Study Status and Sponsor/Collaborators
23	March 5, 2015	Contacts/Locations and Study Status
24	March 23, 2015	Contacts/Locations and Study Status
25	April 13, 2015	Contacts/Locations and Study Status
26	April 20, 2015	Contacts/Locations and Study Status
27	May 6, 2015	Contacts/Locations, Study Status and Study Design
28	May 20, 2015	Study Status
29	June 3, 2015	Study Status
30	June 22, 2015	Contacts/Locations and Study Status
31	July 3, 2015	Contacts/Locations and Study Status
32	July 17, 2015	Contacts/Locations and Study Status
33	August 4, 2015	Contacts/Locations and Study Status
34	August 18, 2015	Study Status
35	September 3, 2015	Contacts/Locations and Study Status
36	September 16, 2015	Contacts/Locations and Study Status
37	October 5, 2015	Recruitment Status, Contacts/Locations and Study Status
38	October 15, 2015	Study Status
39	November 4, 2015	Contacts/Locations and Study Status
40	November 18, 2015	Study Status
41	December 8, 2015	Study Status and Contacts/Locations
42	December 21, 2015	Study Status
43	January 6, 2016	Study Status
44	January 21, 2016	Study Status
45	January 26, 2016	Study Status
46	February 10, 2016	Study Status
47	February 25, 2016	Study Status
48	March 11, 2016	Study Status
49	March 28, 2016	Study Status
50	April 12, 2016	Study Status
51	April 21, 2016	Study Status
52	April 25, 2016	Study Status
53	May 10, 2016	Study Status
54	May 25, 2016	Study Status
55	June 9, 2016	Study Status
56	June 24, 2016	Study Status
57	July 11, 2016	Study Status
58	July 26, 2016	Study Status
59	August 8, 2016	Study Status
60	August 23, 2016	Study Status
61	September 15, 2016	Study Status
62	September 23, 2016	Study Status
63	October 7, 2016	Study Status
64	October 26, 2016	Study Status
65	November 8, 2016	Study Status
66	November 30, 2016	Study Status
67	December 6, 2016	Study Status
68	December 23, 2016	Study Status
69	January 5, 2017	Study Status
70	January 23, 2017	Contacts/Locations and Study Status
71	January 27, 2017	Study Status
72	February 16, 2017	Study Status
73	March 3, 2017	Study Status
74	March 29, 2017	Study Status
75	April 17, 2017	Contacts/Locations and Study Status
76	June 26, 2017	Study Status, Outcome Measures, Contacts/Locations, References, Study Design, Oversight and Results
77	July 25, 2017	Participant Flow and Study Status
78	January 18, 2018	Contacts/Locations and Study Status
79	August 21, 2019	Contacts/Locations, Study Status, References and Outcome Measures
80	November 15, 2019	Study Status and Contacts/Locations
81	December 10, 2019	Study Status
82	January 24, 2020	Study Status and Contacts/Locations
83	May 14, 2020	Study Status and Contacts/Locations
84	June 16, 2020	Study Status
85	July 6, 2020	Contacts/Locations and Study Status
86	June 9, 2021	Contacts/Locations and Study Status
87	March 8, 2022	Contacts/Locations, Study Status, References, Eligibility and Oversight
88	May 2, 2022	Study Status and Contacts/Locations
89	July 19, 2022	Recruitment Status, Study Status and Contacts/Locations
90	February 2, 2023	Adverse Events, Outcome Measures, Participant Flow, Baseline Characteristics, Contacts/Locations, Study Status, More Information and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CA209-026
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
Secondary IDs:	2012-004502-93 [EudraCT Number]

Study Status


Record Verification:	April 2016
Overall Status:	Active, not recruiting
Study Start:	March 2014
Primary Completion:	November 2016 [Anticipated]
Study Completion:	January 2018 [Anticipated]

First Submitted:	January 19, 2014
First Submitted that Met QC Criteria:	January 19, 2014
First Posted:	January 22, 2014 [Estimate]

Last Update Submitted that Met QC Criteria:	July 11, 2016
Last Update Posted:	July 12, 2016 [Estimate]

Sponsor/Collaborators


Sponsor:	Bristol-Myers Squibb
Responsible Party:	Sponsor
Collaborators:	Ono Pharmaceutical Co. Ltd

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

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
Detailed Description:

Conditions


Conditions:	Stage IV or Recurrent Non-Small Cell Lung Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	535 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: Arm A: Nivolumab subjects

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

Biological: Nivolumab

Other Names:

BMS-936558
MDX-1106

Active Comparator: Arm B: Investigator's Choice Chemotherapy

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

Biological: Nivolumab

Other Names:

BMS-936558
MDX-1106

Drug: Gemcitabine

Other Names:

Gemzar

Drug: Cisplatin

Other Names:

Platinol

Drug: Carboplatin

Other Names:

Paraplatin

Drug: Paclitaxel

Other Names:

Taxol

Drug: Pemetrexed

Other Names:

Alimta

Outcome Measures


Primary Outcome Measures:
1.	Progression Free Survival (PFS) as assessed by independent radiology review committee (IRRC) in subjects with strongly Programmed death-ligand 1+ (PD-L1+) tumor expression [ Time Frame: Up to approximately 33 months ] PFS is defined as the time from randomization to the date of the first documented tumor progression as determined by the IRRC (per RECIST 1.1), or death due to any cause
Secondary Outcome Measures:
1.	Objective response rate (ORR) as determined per IRRC in subjects with strongly PD-L1+ tumor expression [ Time Frame: Up to approximately 33 months ] ORR is defined as the number of subjects whose best confirmed objective response is a complete response (CR) or partial response (PR), divided by the number of randomized subjects among strongly PD-L1+ subjects
2.	Overall survival (OS) in subjects with strongly PD-L1+ tumor expression [ Time Frame: At least 33 months ] OS is defined as the time from randomization to the date of death
3.	PFS in all subjects with any PD-L1+ tumor expression [ Time Frame: Up to approximately 33 months ]
4.	Disease related symptom improvement in all subjects [ Time Frame: Up to approximately 33 months ] Disease-related symptom improvement rate is defined as the proportion of randomized subjects who had a disease-related symptom improvement as measured by the lung cancer symptom scale (LCSS) among all PD-L1+ subjects

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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

Contacts/Locations


Study Officials:	Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Locations:	United States, Alabama
	Southern Cancer Center, Inc. Mobile, Alabama, United States, 36608
	United States, Arizona
	Banner Md Anderson Cancer Center Gilbert, Arizona, United States, 85234
	Arizona Oncology Associates Tucson, Arizona, United States, 85704
	United States, California
	Stanford Cancer Institute Stanford, California, United States, 94305
	United States, Colorado
	Anschutz Cancer Pavilion Aurora, Colorado, United States, 80045
	United States, Connecticut
	Yale University New Haven, Connecticut, United States, 06520
	United States, Florida
	Advanced Medical Specialties Miami, Florida, United States, 33176
	Ocala Oncology Center Ocala, Florida, United States, 34471
	H. Lee Moffitt Cancer Center Tampa, Florida, United States, 33612
	United States, Georgia
	Emory University - Winship Cancer Institute Atlanta, Georgia, United States, 30322
	Northwest Georgia Oncology Center, P.C. Marietta, Georgia, United States, 30060
	United States, Illinois
	Rush University Med Ctr Chicago, Illinois, United States, 60612
	United States, Kentucky
	Baptist Health Lexington Lexington, Kentucky, United States, 40503
	United States, Louisiana
	Crescent City Research Consortium, Llc Marrero, Louisiana, United States, 70072
	United States, Maryland
	Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Baltimore, Maryland, United States, 21287
	United States, Massachusetts
	Massachusetts General Hospital Boston, Massachusetts, United States, 02114
	Beth Isreael Deaconess Medical Center Boston, Massachusetts, United States, 02215
	United States, New York
	Roswell Park Cancer Institute Buffalo, New York, United States, 14263
	Laura And Isaac Perlmutter Cancer Center New York, New York, United States, 10016
	Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065
	United States, North Carolina
	University Of North Carolina At Chapel Hill Chapel Hill, North Carolina, United States, 27599
	Duke University Medical Center Durham, North Carolina, United States, 27710
	United States, Ohio
	University Hospitals Of Cleveland Cleveland, Ohio, United States, 44106
	The Ohio State University Columbus, Ohio, United States, 43210
	United States, Oregon
	Oregon Health & Science University Portland, Oregon, United States, 97239
	United States, Pennsylvania
	Network Office Of Research And Innovation Allentown, Pennsylvania, United States, 18103
	University Of Pennsylvania Philadelphia, Pennsylvania, United States, 19104
	Fox Chase Cancer Center Philadelphia, Pennsylvania, United States, 19111
	Upmc Cancer Pavilion Pittsburgh, Pennsylvania, United States, 15232
	United States, South Carolina
	Hollings Cancer Center Charleston, South Carolina, United States, 29425
	St Francis Hospital Greenville, South Carolina, United States, 29601
	United States, Tennessee
	Vanderbilt-Ingram Cancer Ctr Nashville, Tennessee, United States, 37232
	United States, Texas
	University Of Texas Southwestern Medical Center Dallas, Texas, United States, 75390
	The University Of Texas Md Anderson Cancer Center Houston, Texas, United States, 77030
	Cancer Care Centers Of South Texas San Antonio, Texas, United States, 78212
	United States, Washington
	Yakima Valley Memorial Hospital/North Star Lodge Yakima, Washington, United States, 98902
	Argentina
	Local Institution Cordoba, Argentina, 5000
	Argentina, Buenos Aires
	Local Institution Berazategui, Buenos Aires, Argentina, 1880
	Local Institution Capital Federal, Buenos Aires, Argentina, 1426
	Local Institution Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181
	Australia, New South Wales
	Local Institution Camperdown, New South Wales, Australia, 2050
	Australia, Queensland
	Local Institution Brisbane, Queensland, Australia, 4102
	Australia, South Australia
	Local Institution Elizabeth Vale, South Australia, Australia, 5112
	Australia, Victoria
	Local Institution Fitzroy, Victoria, Australia, 3065
	Local Institution Heidelberg, Victoria, Australia, 3084
	Austria
	Local Institution Wels, Austria, 4600
	Local Institution Wien, Austria, 1090
	Belgium
	Universitair Ziekenhuis Brussel Brussels, Belgium, 1090
	Antwerp University Hospital Edegem, Belgium, 2650
	Uz Gent Gent, Belgium, B-9000
	Uz Leuven Leuven, Belgium, 3000
	Brazil, Rio Grande Do Sul
	Local Institution Ijui, Rio Grande Do Sul, Brazil, 98700
	Local Institution Porto Alegre, Rio Grande Do Sul, Brazil, 90610
	Brazil, Sao Paulo
	Local Institution Barretos, Sao Paulo, Brazil, 14780
	Canada, Alberta
	Tom Baker Cancer Centre Calgary, Alberta, Canada, T2N 4N2
	Canada, Ontario
	Juravinski Cancer Centre Hamilton, Ontario, Canada, L8V 5C2
	Princess Margaret Cancer Centre Toronto, Ontario, Canada, M5G 2M9
	Canada, Quebec
	Chum-Hopital Notre-Dame Montreal, Quebec, Canada, H2L 4M1
	Centre De Sante Et De Services Sociaux Rimouski Neigette Rimouski, Quebec, Canada, G5L 5T1
	Czech Republic
	Local Institution Olomouc, Czech Republic, 779 00
	Local Institution Ostrava - Poruba, Czech Republic, 708 52
	Local Institution Praha 8, Czech Republic, 180 81
	Local Institution Usti nad Labem, Czech Republic, 401 13
	Finland
	Local Institution Helsinki, Finland, 00029
	Local Institution Tampere, Finland, 33521
	Local Institution Vaasa, Finland, 65130
	France
	Local Institution Caen, France, 14000
	Local Institution Lille, France, 59000
	Local Institution Marseille Cedex 20, France, 13915
	Local Institution Pontoise Cedex, France, 95303
	Local Institution Rennes Cedex 9, France, 35033
	Local Institution Strasbourg, France, 67090
	Germany
	Sozialstiftung Bamberg Bamberg, Germany, 96049
	Klinik Schillerhoehe Gerlingen, Germany, 70839
	Krankenhaus Grosshansdorf Grosshansdorf, Germany, 22927
	Thoraxklinik-Heidelberg Ggmbh Heidelberg, Germany, 69126
	Local Institution Koeln, Germany, 50937
	Local Institution Wiesbaden, Germany, 65199
	Greece
	Local Institution Athens, Greece, 11527
	Greece, Creta
	Local Institution Heraklion, Creta, Greece, 71110
	Hungary
	Local Institution Budapest, Hungary, 1121
	Local Institution Debrecen, Hungary, 4032
	Local Institution Matrahaza, Hungary, 3233
	Italy
	Azienda Ospedaliera Moscati Avellino, Italy, 83100
	Local Institution Livorno, Italy, 57100
	Local Institution Milano, Italy, 20141
	Local Institution Napoli, Italy, 80131
	Local Institution Perugia, Italy, 06132
	Local Institution Terni, Italy, 05100
	Japan
	Local Institution Akashi, Hyogo, Japan, 673-8558
	Local Institution Habikino City, Osaka, Japan, 5838588
	Local Institution Kobe, Hyogo, Japan, 6500047
	Local Institution Ota, Gunma, Japan, 3738550
	Local Institution Sapporo, Hokkaido, Japan, 062-0931
	Local Institution Tokyo, Japan, 1358550
	Local Institution Wakayama, Japan, 641-8510
	Japan, Aichi
	Local Institution Nagoya, Aichi, Japan, 4648681
	Local Institution Nagoya-shi, Aichi, Japan, 4600001
	Japan, Ehime
	Local Institution Matsuyama-shi, Ehime, Japan, 7910280
	Japan, Miyagi
	Local Institution Natori-shi, Miyagi, Japan, 9811293
	Japan, Niigata
	Local Institution Niigata-shi, Niigata, Japan, 9518566
	Japan, Osaka
	Local Institution Osaka-sayama, Osaka, Japan, 589-8511
	Local Institution Osaka-shi, Osaka, Japan, 5340021
	Local Institution Sakai-shi, Osaka, Japan, 591-8555
	Japan, Saitama
	Local Institution Kitaadachi-gun, Saitama, Japan, 3620806
	Japan, Shizuoka
	Local Institution Sunto-gun, Shizuoka, Japan, 4118777
	Japan, Tokyo
	Local Institution Chuo-ku, Tokyo, Japan, 1040045
	Korea, Republic of
	Local Institution Seoul, Korea, Republic of, 120-752
	Local Institution Seoul, Korea, Republic of, 135-710
	Local Institution Seoul, Korea, Republic of
	Mexico, Distrito Federal
	Local Institution Mexico City, Distrito Federal, Mexico, 14080
	Mexico, Jalisco
	Local Institution Guadalajara, Jalisco, Mexico, 44280
	Mexico, Yucatan
	Local Institution Merida, Yucatan, Mexico, 97133
	Netherlands
	Antoni Van Leeuwenhoek Ziekenhuis Amsterdam, Netherlands, 1066 CX
	Umcg, Universitair Medisch Centrum Groningen Groningen, Netherlands, 9713 GZ
	Local Institution Rotterdam, Netherlands, 3015 CE
	Poland
	Local Institution Bydgoszcz, Poland, 85-796
	Local Institution Krakow, Poland, 31-202
	Local Institution Lodz, Poland, 93-513
	Local Institution Warszawa, Poland, 02-781
	Local Institution Wodzislaw Slaski, Poland, 44-300
	Romania
	Local Institution Cluj Napoca, Romania, 400015
	Local Institution Cluj-napoca, Romania, 400352
	Local Institution Ploiesti, Romania, 100337
	Spain
	Local Institution Barcelona, Spain, 08035
	Local Institution Las Palmas De Gran Canaria, Spain, 35016
	Local Institution Madrid, Spain, 28050
	Local Institution Malaga, Spain, 29010
	Local Institution Sevilla, Spain, 41013
	Local Institution Valencia, Spain, 46014
	Sweden
	Local Institution Stockholm, Sweden, 171 76
	Local Institution Uppsala, Sweden, 751 85
	Switzerland
	Local Institution Chur, Switzerland, 7000
	Local Institution Lausanne, Switzerland, 1011
	Local Institution Zuerich, Switzerland, 8091
	Taiwan
	Local Institution Taipei, Taiwan, 11217
	Turkey
	Local Institution Kayseri, Turkey, 38039
	United Kingdom, Greater London
	North Middlesex University Hospital London, Greater London, United Kingdom, N18 1QX
	United Kingdom, Greater Manchester
	Christie Hospital Nhs Trust Manchester, Greater Manchester, United Kingdom, M20 4XB
	United Kingdom, Yorkshire
	St James'S University Hospital Leeds, Yorkshire, United Kingdom, LS9 7TF

IPDSharing


Plan to Share IPD:

References


Links:	URL: http://www.bms.com/studyconnect/Pages/home.aspx Description: BMS clinical trial educational resource
Available IPD/Information: