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A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC (CheckMate 9LA)

Primary Purpose

Non-Small Cell Lung Cancer

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

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
  • 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
  • Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period

Exclusion Criteria:

  • Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
  • Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
  • Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment

Other protocol inclusion/exclusion criteria may apply

Sites / Locations

  • Memorial Health Systems
  • Local Institution - 0044
  • Baptist MD Anderson Cancer Center
  • Local Institution - 0029
  • Local Institution - 0091
  • Local Institution - 0004
  • Henry Ford Health System
  • Local Institution - 0058
  • Local Institution - 0098
  • Local Institution - 0095
  • Local Institution - 0006
  • UPMC Hillman Cancer Center
  • Local Institution - 0093
  • Local Institution - 0094
  • Southwest Regional Cancer Clinic
  • University of Wisconsin Carbone Cancer Center
  • Local Institution - 0014
  • Local Institution - 0028
  • Local Institution - 0026
  • Local Institution - 0027
  • Local Institution - 0030
  • Local Institution - 0086
  • Local Institution - 0040
  • Local Institution - 0089
  • Local Institution - 0036
  • Local Institution - 0078
  • Local Institution - 0002
  • Local Institution - 0033
  • Local Institution - 0001
  • Local Institution - 0068
  • Local Institution - 0063
  • Local Institution - 0067
  • Local Institution - 0069
  • Local Institution - 0064
  • Local Institution - 0065
  • Local Institution - 0066
  • Local Institution - 0070
  • Local Institution - 0090
  • Local Institution - 0083
  • Local Institution - 0082
  • Local Institution - 0080
  • Local Institution - 0084
  • Local Institution - 0059
  • Local Institution - 0079
  • Local Institution - 0139
  • Local Institution - 0146
  • Local Institution - 0148
  • Local Institution - 0120
  • Local Institution - 0144
  • Local Institution - 0106
  • Local Institution - 0108
  • Local Institution - 0110
  • Local Institution - 0111
  • Local Institution - 0113
  • Local Institution - 0112
  • Local Institution - 0010
  • Local Institution - 0009
  • Local Institution - 0013
  • Local Institution - 0071
  • Local Institution - 0012
  • Local Institution - 0035
  • Local Institution - 0011
  • Local Institution - 0097
  • Local Institution - 0073
  • Local Institution - 0016
  • Local Institution - 0072
  • Local Institution - 0019
  • Local Institution - 0017
  • Local Institution - 0074
  • Local Institution - 0015
  • Local Institution - 0018
  • Local Institution - 0021
  • Local Institution - 0020
  • Ospedale San Luca
  • Ospedale San Raffaele
  • Local Institution - 0043
  • Local Institution - 0101
  • Local Institution - 0118
  • Local Institution - 0128
  • Local Institution - 0138
  • Local Institution - 0137
  • Local Institution - 0127
  • Local Institution - 0131
  • Local Institution - 0119
  • Local Institution - 0104
  • Local Institution - 0115
  • Local Institution - 0100
  • Local Institution - 0129
  • Local Institution - 0114
  • Local Institution - 0134
  • Local Institution - 0116
  • Local Institution - 0136
  • Local Institution - 0135
  • Local Institution - 0103
  • Local Institution - 0130
  • Local Institution - 0102
  • Local Institution - 0132
  • Local Institution - 0077
  • Local Institution - 0061
  • Local Institution - 0075
  • Local Institution - 0087
  • Local Institution - 0022
  • Local Institution - 0085
  • Local Institution - 0034
  • Local Institution - 0031
  • Local Institution - 0032
  • Local Institution - 0024
  • Local Institution - 0025
  • Local Institution - 0054
  • Local Institution - 0053
  • Local Institution - 0052
  • Local Institution - 0055
  • Local Institution - 0056
  • Local Institution - 0050
  • Local Institution - 0049
  • Local Institution - 0048

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Module A

Module B

Arm Description

Chemotherapy/Biologics combined

Chemotherapy Combination

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.

Secondary Outcome Measures

Progression Free Survival (PFS) by BICR
PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died 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 randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
Objective Response Rate (ORR) by BICR
ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.
Duration of Response (DoR)
DoR was defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented BICR-assessed tumor progression (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who started subsequent therapy (including palliative local therapy) without a prior reported progression were censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy (including palliative local therapy). Participants who died without a reported prior progression were considered to have progressed on the date of their death. For subjects who neither progressed nor died, DoR was censored on the date of their last evaluable tumor assessment. DoR was evaluated for responders (confirmed CR or PR) only.
Time to Response (TTR)
TTR was defined as the time from randomization to the date of the first confirmed documented response (CR or PR), as assessed by the BICR. TTR was evaluated for responders (confirmed CR or PR) only.
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
PD-L1 expression was defined as the percent of tumor cells with membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC 28-8 pharmDx test. PD-L1 expression was classified as PD-L1 ≥1% (≥1% tumor cells with membrane staining in a minimum of a hundred evaluable tumor cells), PD-L1 < 1% and PD-L1 not quantifiable (without quantifiable PD-L1 expression), PD-L1 expression ≥ 50%, PD-L1 expression 1 to 49%
PFS by BICR by PD-L1 Tumor Cell Expression
PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died 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 randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
OS by PD-L1 Tumor Cell Expression
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.

Full Information

First Posted
July 11, 2017
Last Updated
September 6, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03215706
Brief Title
A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
Acronym
CheckMate 9LA
Official Title
A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
August 16, 2019 (Actual)
Study Completion Date
January 19, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

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 determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
719 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Module A
Arm Type
Experimental
Arm Description
Chemotherapy/Biologics combined
Arm Title
Module B
Arm Type
Active Comparator
Arm Description
Chemotherapy Combination
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, BMS734016
Intervention Description
Specified dose on specified day
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS936558
Intervention Description
Specified dose on specified day
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Specified dose on specified day
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Specified dose on specified day
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
Specified dose on specified day
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Description
Specified dose on specified day
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
Time Frame
From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) by BICR
Description
PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died 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 randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
Time Frame
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months)
Title
Objective Response Rate (ORR) by BICR
Description
ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.
Time Frame
From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months)
Title
Duration of Response (DoR)
Description
DoR was defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented BICR-assessed tumor progression (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who started subsequent therapy (including palliative local therapy) without a prior reported progression were censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy (including palliative local therapy). Participants who died without a reported prior progression were considered to have progressed on the date of their death. For subjects who neither progressed nor died, DoR was censored on the date of their last evaluable tumor assessment. DoR was evaluated for responders (confirmed CR or PR) only.
Time Frame
From date of first confirmed response to date of tumor progression (assessed up to October 2019, approximately 23 months)
Title
Time to Response (TTR)
Description
TTR was defined as the time from randomization to the date of the first confirmed documented response (CR or PR), as assessed by the BICR. TTR was evaluated for responders (confirmed CR or PR) only.
Time Frame
From date of randomization to date of first confirmed documented response (assessed up to October 2019, approximately 23 months)
Title
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
Description
PD-L1 expression was defined as the percent of tumor cells with membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC 28-8 pharmDx test. PD-L1 expression was classified as PD-L1 ≥1% (≥1% tumor cells with membrane staining in a minimum of a hundred evaluable tumor cells), PD-L1 < 1% and PD-L1 not quantifiable (without quantifiable PD-L1 expression), PD-L1 expression ≥ 50%, PD-L1 expression 1 to 49%
Time Frame
From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months)
Title
PFS by BICR by PD-L1 Tumor Cell Expression
Description
PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died 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 randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
Time Frame
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months)
Title
OS by PD-L1 Tumor Cell Expression
Description
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
Time Frame
From date of randomization to date of death (assessed up to October 2019, approximately 23 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy 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 Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period Exclusion Criteria: Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment Other protocol inclusion/exclusion criteria may apply
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
Memorial Health Systems
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Local Institution - 0044
City
Plainville
State/Province
Connecticut
ZIP/Postal Code
06062
Country
United States
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Local Institution - 0029
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Local Institution - 0091
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Local Institution - 0004
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Local Institution - 0058
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Local Institution - 0098
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Local Institution - 0095
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Local Institution - 0006
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Local Institution - 0093
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Local Institution - 0094
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Southwest Regional Cancer Clinic
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Local Institution - 0014
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Local Institution - 0028
City
Rio Cuarto
State/Province
Cordoba
ZIP/Postal Code
5800
Country
Argentina
Facility Name
Local Institution - 0026
City
Viedma
State/Province
Rio Negro
ZIP/Postal Code
8500
Country
Argentina
Facility Name
Local Institution - 0027
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Local Institution - 0030
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0086
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Local Institution - 0040
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Local Institution - 0089
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Local Institution - 0036
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 0078
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution - 0002
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Local Institution - 0033
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0001
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Local Institution - 0068
City
Natal
State/Province
RIO Grande DO Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Local Institution - 0063
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution - 0067
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Local Institution - 0069
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Facility Name
Local Institution - 0064
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14780-070
Country
Brazil
Facility Name
Local Institution - 0065
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Local Institution - 0066
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Local Institution - 0070
City
São Paulo
ZIP/Postal Code
01327-001
Country
Brazil
Facility Name
Local Institution - 0090
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Local Institution - 0083
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Local Institution - 0082
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Local Institution - 0080
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Local Institution - 0084
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Local Institution - 0059
City
Santiago
State/Province
Región Metropolitana De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Local Institution - 0079
City
Vina Del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520612
Country
Chile
Facility Name
Local Institution - 0139
City
Beijing
State/Province
BEI
ZIP/Postal Code
100142
Country
China
Facility Name
Local Institution - 0146
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Local Institution - 0148
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Local Institution - 0120
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Local Institution - 0144
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Local Institution - 0106
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Local Institution - 0108
City
Xi'an City
State/Province
Shan3xi
ZIP/Postal Code
710038
Country
China
Facility Name
Local Institution - 0110
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Local Institution - 0111
City
Zhejiang
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Local Institution - 0113
City
Beijing
ZIP/Postal Code
102206
Country
China
Facility Name
Local Institution - 0112
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Local Institution - 0010
City
Bron
State/Province
Rhone Alpes
ZIP/Postal Code
69500
Country
France
Facility Name
Local Institution - 0009
City
Lyon Cedex08
State/Province
Rhône-Alpes
ZIP/Postal Code
69373
Country
France
Facility Name
Local Institution - 0013
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Local Institution - 0071
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution - 0012
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution - 0035
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution - 0011
City
Paris Cedex 20
ZIP/Postal Code
75970
Country
France
Facility Name
Local Institution - 0097
City
Saint-Brieuc
ZIP/Postal Code
22027
Country
France
Facility Name
Local Institution - 0073
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Local Institution - 0016
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Local Institution - 0072
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Local Institution - 0019
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Local Institution - 0017
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Local Institution - 0074
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Local Institution - 0015
City
Muenchen
ZIP/Postal Code
81925
Country
Germany
Facility Name
Local Institution - 0018
City
Yes
ZIP/Postal Code
70376
Country
Germany
Facility Name
Local Institution - 0021
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Local Institution - 0020
City
Limerick
ZIP/Postal Code
V94 F858
Country
Ireland
Facility Name
Ospedale San Luca
City
Lucca
ZIP/Postal Code
5510
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Local Institution - 0043
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0101
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
9601295
Country
Japan
Facility Name
Local Institution - 0118
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
3718511
Country
Japan
Facility Name
Local Institution - 0128
City
Ota-shi
State/Province
Gunma
ZIP/Postal Code
3738550
Country
Japan
Facility Name
Local Institution - 0138
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
7308518
Country
Japan
Facility Name
Local Institution - 0137
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
7348511
Country
Japan
Facility Name
Local Institution - 0127
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution - 0131
City
Akashi-shi
State/Province
Hyogo
ZIP/Postal Code
6738558
Country
Japan
Facility Name
Local Institution - 0119
City
Himeji-shi
State/Province
Hyogo
ZIP/Postal Code
6708520
Country
Japan
Facility Name
Local Institution - 0104
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
Facility Name
Local Institution - 0115
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
9208641
Country
Japan
Facility Name
Local Institution - 0100
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
0283695
Country
Japan
Facility Name
Local Institution - 0129
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2210855
Country
Japan
Facility Name
Local Institution - 0114
City
Yokohama-Shi
State/Province
Kanagawa
ZIP/Postal Code
2360051
Country
Japan
Facility Name
Local Institution - 0134
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2418515
Country
Japan
Facility Name
Local Institution - 0116
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
9518566
Country
Japan
Facility Name
Local Institution - 0136
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7008558
Country
Japan
Facility Name
Local Institution - 0135
City
Habikino-shi
State/Province
Osaka
ZIP/Postal Code
5838588
Country
Japan
Facility Name
Local Institution - 0103
City
Osaka-sayama-shi
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution - 0130
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5458586
Country
Japan
Facility Name
Local Institution - 0102
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
3620806
Country
Japan
Facility Name
Local Institution - 0132
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
7550241
Country
Japan
Facility Name
Local Institution - 0077
City
La Paz
State/Province
BAJA Californa SUR
ZIP/Postal Code
23040
Country
Mexico
Facility Name
Local Institution - 0061
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Local Institution - 0075
City
Veracruz, Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Local Institution - 0087
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Local Institution - 0022
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Local Institution - 0085
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Local Institution - 0034
City
Bucharest
ZIP/Postal Code
020122
Country
Romania
Facility Name
Local Institution - 0031
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution - 0032
City
Craiova
ZIP/Postal Code
200542
Country
Romania
Facility Name
Local Institution - 0024
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution - 0025
City
St.petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution - 0054
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution - 0053
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0052
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0055
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 0056
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution - 0050
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Local Institution - 0049
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Local Institution - 0048
City
Tauton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33476593
Citation
Paz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Salman P, Souquet PJ, De Marchi P, Martin C, Perol M, Scherpereel A, Lu S, John T, Carbone DP, Meadows-Shropshire S, Agrawal S, Oukessou A, Yan J, Reck M. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):198-211. doi: 10.1016/S1470-2045(20)30641-0. Epub 2021 Jan 18. Erratum In: Lancet Oncol. 2021 Mar;22(3):e92.
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

Learn more about this trial

A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

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