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 2014
Overall Status:	Recruiting
Study Start:	March 2014
Primary Completion:	January 2017 [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:	May 7, 2014
Last Update Posted:	May 8, 2014 [Estimate]

Sponsor/Collaborators


Sponsor:	Bristol-Myers Squibb
Responsible Party:	Sponsor
Collaborators:

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:	495 [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


Central Contact Person:	Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Email: Clinical.Trials@bms.com
Central Contact Backup:	First line of the email MUST contain NCT# and Site #.
Study Officials:	Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Locations:	Argentina
	Local Institution [Not yet recruiting] Cordoba, Argentina, 5000 Contact:Contact: Site 0048
	Local Institution [Not yet recruiting] Cordoba, Argentina, 5000 Contact:Contact: Site 0050
	Argentina, Buenos Aires
	Local Institution [Not yet recruiting] Berazategui, Buenos Aires, Argentina, 1880 Contact:Contact: Site 0051
	Local Institution [Not yet recruiting] Capital Federal, Buenos Aires, Argentina, 1426 Contact:Contact: Site 0049
	Local Institution [Not yet recruiting] Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181 Contact:Contact: Site 0052
	Australia, New South Wales
	Local Institution [Not yet recruiting] Camperdown, New South Wales, Australia, 2050 Contact:Contact: Site 0090
	Australia, Queensland
	Local Institution [Not yet recruiting] Brisbane, Queensland, Australia, 4102 Contact:Contact: Site 0091
	Australia, South Australia
	Local Institution [Not yet recruiting] Elizabeth Vale, South Australia, Australia, 5112 Contact:Contact: Site 0071
	Australia, Victoria
	Local Institution [Not yet recruiting] Fitzroy, Victoria, Australia, 3065 Contact:Contact: Site 0072
	Local Institution [Not yet recruiting] Heidelberg, Victoria, Australia, 3084 Contact:Contact: Site 0104
	Belgium
	Local Institution [Not yet recruiting] Brussels, Belgium, 1090 Contact:Contact: Site 0044
	Local Institution [Not yet recruiting] Edegem, Belgium, 2650 Contact:Contact: Site 0055
	Local Institution [Not yet recruiting] Gent, Belgium, B-9000 Contact:Contact: Site 0056
	Brazil
	Local Institution [Not yet recruiting] Sao Paulo, Brazil, 01308 Contact:Contact: Site 0136
	Local Institution [Not yet recruiting] Sao Paulo, Brazil, 01509 Contact:Contact: Site 0137
	Brazil, Rio Grande Do Sul
	Local Institution [Not yet recruiting] Ijui, Rio Grande Do Sul, Brazil, 98700 Contact:Contact: Site 0134
	Local Institution [Not yet recruiting] Porto Alegre, Rio Grande Do Sul, Brazil, 90610 Contact:Contact: Site 0133
	Brazil, Sao Paulo
	Local Institution [Not yet recruiting] Barretos, Sao Paulo, Brazil, 14780 Contact:Contact: Site 0135
	Canada, Alberta
	Local Institution [Not yet recruiting] Calgary, Alberta, Canada, T2N 4N2 Contact:Contact: Site 0086
	Canada, Ontario
	Local Institution [Not yet recruiting] Hamilton, Ontario, Canada, L8V 5C2 Contact:Contact: Site 0115
	Local Institution [Not yet recruiting] Toronto, Ontario, Canada, M5G 2M9 Contact:Contact: Site 0113
	Canada, Quebec
	Local Institution [Not yet recruiting] Montreal, Quebec, Canada, H2L 4M1 Contact:Contact: Site 0110
	Local Institution [Recruiting] Rimouski, Quebec, Canada, G5L 5T1 Contact:Contact: Site 0109
	Czech Republic
	Local Institution [Not yet recruiting] Olomouc, Czech Republic, 775 20 Contact:Contact: Site 0059
	Local Institution [Not yet recruiting] Ostrava - Poruba, Czech Republic, 708 52 Contact:Contact: Site 0061
	Local Institution [Not yet recruiting] Praha 8, Czech Republic, 180 81 Contact:Contact: Site 0058
	Local Institution [Not yet recruiting] Usti nad Labem, Czech Republic, 401 13 Contact:Contact: Site 0060
	Finland
	Local Institution [Not yet recruiting] Helsinki, Finland, 00029 Contact:Contact: Site 0120
	Local Institution [Not yet recruiting] Tampere, Finland, 33521 Contact:Contact: Site 0119
	Local Institution [Not yet recruiting] Vaasa, Finland, 65130 Contact:Contact: Site 0118
	Hungary
	Local Institution [Not yet recruiting] Budapest, Hungary, 1121 Contact:Contact: Site 0126
	Local Institution [Not yet recruiting] Debrecen, Hungary, 4032 Contact:Contact: Site 0116
	Local Institution [Not yet recruiting] Matrahaza, Hungary, 3233 Contact:Contact: Site 0094
	Netherlands
	Local Institution [Not yet recruiting] Amsterdam, Netherlands, 1066 CX Contact:Contact: Site 0045
	Local Institution [Not yet recruiting] Groningen, Netherlands, 9713 GZ Contact:Contact: Site 0057
	Local Institution [Not yet recruiting] Rotterdam, Netherlands, 3015 CE Contact:Contact: Site 0046
	Poland
	Local Institution [Not yet recruiting] Bydgoszcz, Poland, 85-796 Contact:Contact: Site 0114
	Local Institution [Not yet recruiting] Warszawa, Poland, 02-781 Contact:Contact: Site 0089
	Local Institution [Not yet recruiting] Wodzislaw Slaski, Poland, 44-300 Contact:Contact: Site 0093
	Romania
	Local Institution [Not yet recruiting] Cluj Napoca, Romania, 400015 Contact:Contact: Site 0068
	Local Institution [Not yet recruiting] Cluj-napoca, Romania, 400352 Contact:Contact: Site 0067
	Local Institution [Not yet recruiting] Ploiesti, Romania, 100337 Contact:Contact: Site 0069
	Spain
	Local Institution [Not yet recruiting] Barcelona, Spain, 08035 Contact:Contact: Site 0040
	Local Institution [Not yet recruiting] Las Palmas De Gran Canaria, Spain, 35016 Contact:Contact: Site 0041
	Local Institution [Not yet recruiting] Madrid, Spain, 28050 Contact:Contact: Site 0047
	Local Institution [Not yet recruiting] Malaga, Spain, 29010 Contact:Contact: Site 0042
	Local Institution [Not yet recruiting] Sevilla, Spain, 41013 Contact:Contact: Site 0039
	Local Institution [Not yet recruiting] Valencia, Spain, 46014 Contact:Contact: Site 0043
	Sweden
	Local Institution [Not yet recruiting] Stockholm, Sweden, 171 76 Contact:Contact: Site 0127
	Local Institution [Not yet recruiting] Uppsala, Sweden, 751 85 Contact:Contact: Site 0125
	Turkey
	Local Institution [Not yet recruiting] Adana, Turkey, 01120 Contact:Contact: Site 0128
	Local Institution [Not yet recruiting] Ankara, Turkey, 06500 Contact:Contact: Site 0129
	Local Institution [Not yet recruiting] Istanbul, Turkey, 81190 Contact:Contact: Site 0138
	Local Institution [Not yet recruiting] Kayseri, Turkey, 38039 Contact:Contact: Site 0130
	United Kingdom, Greater London
	Local Institution [Not yet recruiting] London, Greater London, United Kingdom, N18 1QX Contact:Contact: Site 0098
	United Kingdom, Greater Manchester
	Local Institution [Not yet recruiting] Manchester, Greater Manchester, United Kingdom, M20 4XB Contact:Contact: Site 0097
	United Kingdom, Yorkshire
	Local Institution [Not yet recruiting] Leeds, Yorkshire, United Kingdom, LS9 7TF Contact:Contact: Site 0053

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: