History of Changes for Study: NCT02477826

An Open-Label, Trial of Nivolumab and Nivolumab Plus Ipilimumab Versus Platinum Doublet Chemotherapy in Subjects With Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 227)

Latest version (submitted January 5, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	June 18, 2015	None (earliest Version on record)
2	June 25, 2015	Arms and Interventions and Study Status
3	July 17, 2015	Recruitment Status, Study Status and Contacts/Locations
4	August 4, 2015	Contacts/Locations and Study Status
5	August 19, 2015	Contacts/Locations and Study Status
6	September 2, 2015	Study Status and Contacts/Locations
7	September 3, 2015	Sponsor/Collaborators and Study Status
8	September 16, 2015	Contacts/Locations and Study Status
9	October 1, 2015	Contacts/Locations and Study Status
10	November 3, 2015	Contacts/Locations, Arms and Interventions, Study Status, Study Identification and Study Description
11	November 4, 2015	Study Status
12	November 18, 2015	Contacts/Locations and Study Status
13	December 8, 2015	Contacts/Locations and Study Status
14	December 21, 2015	Contacts/Locations and Study Status
15	January 6, 2016	Contacts/Locations and Study Status
16	January 21, 2016	Contacts/Locations and Study Status
17	January 26, 2016	Contacts/Locations and Study Status
18	February 10, 2016	Contacts/Locations and Study Status
19	March 8, 2016	Contacts/Locations and Study Status
20	March 11, 2016	Contacts/Locations and Study Status
21	March 28, 2016	Contacts/Locations and Study Status
22	April 12, 2016	Contacts/Locations and Study Status
23	April 25, 2016	Contacts/Locations and Study Status
24	May 3, 2016	Study Status and Study Identification
25	May 10, 2016	Contacts/Locations and Study Status
26	May 25, 2016	Contacts/Locations and Study Status
27	June 9, 2016	Contacts/Locations and Study Status
28	June 24, 2016	Contacts/Locations and Study Status
29	July 11, 2016	Contacts/Locations and Study Status
30	July 26, 2016	Contacts/Locations and Study Status
31	August 8, 2016	Contacts/Locations and Study Status
32	August 23, 2016	Contacts/Locations and Study Status
33	September 7, 2016	Contacts/Locations and Study Status
34	September 14, 2016	Study Status
35	September 23, 2016	Contacts/Locations and Study Status
36	October 7, 2016	Contacts/Locations and Study Status
37	October 26, 2016	Contacts/Locations and Study Status
38	November 8, 2016	Contacts/Locations, Study Design and Study Status
39	January 26, 2017	Outcome Measures, Arms and Interventions, Oversight, Study Status and Eligibility
40	March 7, 2017	Study Status and Oversight
41	April 18, 2017	Contacts/Locations, Study Description, Study Status and Study Identification
42	August 22, 2017	Contacts/Locations and Study Status
43	November 21, 2017	Contacts/Locations and Study Status
44	February 12, 2018	Study Status
45	June 19, 2018	Contacts/Locations and Study Status
46	July 3, 2018	Contacts/Locations and Study Status
47	September 12, 2018	Contacts/Locations, Study Status, Arms and Interventions and References
48	October 2, 2018	Contacts/Locations and Study Status
49	November 28, 2018	Contacts/Locations and Study Status
50	August 5, 2019	Study Status
51	August 10, 2020	Study Status
52	September 9, 2020	Contacts/Locations and Study Status
53	March 19, 2021	Contacts/Locations, Study Status and References
54	September 20, 2021	Contacts/Locations, Study Status and Study Design
55	March 2, 2022	Recruitment Status, Contacts/Locations, Study Status, Study Design, Oversight, References and Eligibility
56	May 19, 2022	Contacts/Locations and Study Status
57	October 25, 2022	Contacts/Locations, Study Status and References
58	November 27, 2022	Contacts/Locations and Study Status
59	November 30, 2022	Study Status
60	December 19, 2022	Study Status
61	April 17, 2023	Contacts/Locations and Study Status
62	April 21, 2023	Study Status
63	May 12, 2023	Study Status
64	May 17, 2023	Study Status
65	May 30, 2023	Contacts/Locations and Study Status
66	July 10, 2023	Contacts/Locations and Study Status
67	September 5, 2023	Study Status and Contacts/Locations
68	September 11, 2023	Study Status
69	October 4, 2023	Contacts/Locations and Study Status
70	October 30, 2023	Study Status
71	December 6, 2023	Study Status and Contacts/Locations
72	January 5, 2024	References, Study Status and Contacts/Locations

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Study NCT02477826
Submitted Date: June 18, 2015 (v1)

Study Identification


Unique Protocol ID:	CA209-227
Brief Title:	An Open-Label, Trial of Nivolumab and Nivolumab Plus Ipilimumab Versus Platinum Doublet Chemotherapy in Subjects With Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 227)
Official Title:	An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Secondary IDs:	2014-003630-23 [EudraCT Number]

Study Status


Record Verification:	June 2015
Overall Status:	Not yet recruiting
Study Start:	August 2015
Primary Completion:	January 2018 [Anticipated]
Study Completion:	December 2020 [Anticipated]

First Submitted:	June 18, 2015
First Submitted that Met QC Criteria:	June 18, 2015
First Posted:	June 23, 2015 [Estimate]

Last Update Submitted that Met QC Criteria:	June 18, 2015
Last Update Posted:	June 23, 2015 [Estimate]

Study Description


Brief Summary:	The purpose of this study is to show that Nivolumab or Nivolumab plus ipilimumab, improves progression free survival and/or overall survival compared with chemotherapy in subjects advanced lung cancer.
Detailed Description:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	1980 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Arm A: Nivolumab Nivolumab intravenously (IV) as specified	Drug: Nivolumab Other Names: Opdivo
Experimental: Arm B: Nivolumab + Ipilimumab Nivolumab + Ipilimumab IV as specified	Drug: Nivolumab Other Names: Opdivo Drug: Ipilimumab Other Names: Yervoy
Active Comparator: Arm C: Platinum doublet chemotherapy Chemotherapy administered on specified days of IV chemotherapy. Squamous histology: Gemcitabine with cisplatin dose as specified or Gemcitabine with cisplatin dose as specified or Non-squamous histology: Pemetrexed with cisplatin dose as specified or Pemetrexed with carboplatin dose as specified	Drug: CarboplatinDrug: CisplatinDrug: GemcitabineDrug: Pemetrexed

Outcome Measures


Primary Outcome Measures:
1.	Overall survival (OS) [ Time Frame: approximately 48 months ] OS of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer
2.	Progression-free survival (PFS) [ Time Frame: approximately 40 months ] PFS of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer
Secondary Outcome Measures:
1.	Objective response rate (ORR) [ Time Frame: upto 48 months ] ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer
2.	Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects [ Time Frame: upto 48 months ] Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment

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: Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria Exclusion Criteria: Subjects with untreated Central nervous system (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

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:

References


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

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