ClinicalTrials.gov
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)
Latest version (submitted February 2, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B 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
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Study NCT02041533
Submitted Date:  February 28, 2014 (v2)
Open or close this module 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]
Open or close this module Study Status
Record Verification: February 2014
Overall Status: Not yet 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:		 February 28, 2014
Last Update Posted: March 3, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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:
Open or close this module Conditions
Conditions: Stage IV or Recurrent Non-Small Cell Lung Cancer
Keywords:
Open or close this module 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]
Open or close this module 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
Open or close this module 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
Open or close this module 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
Open or close this module Contacts/Locations
Study Officials: Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services