Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03215706
Registration number
NCT03215706
Ethics application status
Date submitted
11/07/2017
Date registered
12/07/2017
Date last updated
10/01/2024
Titles & IDs
Public title
A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2017-001195-35
Query!
Secondary ID [2]
0
0
CA209-9LA
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CheckMate 9LA
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Lung - Small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Ipilimumab
Treatment: Other - Nivolumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Experimental: Module A - Chemotherapy/Biologics combined
Active comparator: Module B - Chemotherapy Combination
Treatment: Other: Ipilimumab
Specified dose on specified day
Treatment: Other: Nivolumab
Specified dose on specified day
Treatment: Drugs: Carboplatin
Specified dose on specified day
Treatment: Drugs: Paclitaxel
Specified dose on specified day
Treatment: Drugs: Pemetrexed
Specified dose on specified day
Treatment: Drugs: Cisplatin
Specified dose on specified day
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
Query!
Secondary outcome [1]
0
0
Progression Free Survival (PFS) by BICR
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
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)
Query!
Secondary outcome [2]
0
0
Objective Response Rate (ORR) by BICR
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
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)
Query!
Secondary outcome [3]
0
0
Duration of Response (DoR)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
From date of first confirmed response to date of tumor progression (assessed up to October 2019, approximately 23 months)
Query!
Secondary outcome [4]
0
0
Time to Response (TTR)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
From date of randomization to date of first confirmed documented response (assessed up to October 2019, approximately 23 months)
Query!
Secondary outcome [5]
0
0
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
Query!
Assessment method [5]
0
0
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%
Query!
Timepoint [5]
0
0
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)
Query!
Secondary outcome [6]
0
0
PFS by BICR by PD-L1 Tumor Cell Expression
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
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)
Query!
Secondary outcome [7]
0
0
OS by PD-L1 Tumor Cell Expression
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
Query!
Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
24/08/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
19/01/2026
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
719
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - 0086 - Gosford
Query!
Recruitment hospital [2]
0
0
Local Institution - 0040 - Bedford Park
Query!
Recruitment hospital [3]
0
0
Local Institution - 0089 - Box Hill
Query!
Recruitment hospital [4]
0
0
Local Institution - 0036 - Heidelberg
Query!
Recruitment hospital [5]
0
0
Local Institution - 0078 - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
2250 - Gosford
Query!
Recruitment postcode(s) [2]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [3]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [4]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [5]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Colorado
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kansas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kentucky
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Michigan
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Ohio
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
South Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Utah
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Wisconsin
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Buenos Aires
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Cordoba
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Rio Negro
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Santa Fe
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Gilly
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Leuven
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Roeselare
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
RIO Grande DO Norte
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Rio Grande Do Sul
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Santa Catarina
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Sao Paulo
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Rio De Janeiro
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
São Paulo
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Quebec
Query!
Country [28]
0
0
Chile
Query!
State/province [28]
0
0
Metropolitana
Query!
Country [29]
0
0
Chile
Query!
State/province [29]
0
0
Región Metropolitana De Santiago
Query!
Country [30]
0
0
Chile
Query!
State/province [30]
0
0
Valparaiso
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
BEI
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Hainan
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Henan
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Hunan
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Jilin
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Shan3xi
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Zhejiang
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Beijing
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Shanghai
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Rhone Alpes
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Rhône-Alpes
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Caen
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Lille Cedex
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Montpellier
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Nantes
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Paris Cedex 20
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Saint-Brieuc
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Berlin
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Gauting
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Grosshansdorf
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Hemer
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Immenhausen
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Magdeburg
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Muenchen
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Yes
Query!
Country [56]
0
0
Ireland
Query!
State/province [56]
0
0
Dublin
Query!
Country [57]
0
0
Ireland
Query!
State/province [57]
0
0
Limerick
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Lucca
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Milano
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Napoli
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Fukushima
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Gunma
Query!
Country [63]
0
0
Japan
Query!
State/province [63]
0
0
Hiroshima
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Hokkaido
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Hyogo
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Ishikawa
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Iwate
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Kanagawa
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Niigata
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Okayama
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Osaka
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Saitama
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Yamaguchi
Query!
Country [74]
0
0
Mexico
Query!
State/province [74]
0
0
BAJA Californa SUR
Query!
Country [75]
0
0
Mexico
Query!
State/province [75]
0
0
Jalisco
Query!
Country [76]
0
0
Mexico
Query!
State/province [76]
0
0
Veracruz, Veracruz
Query!
Country [77]
0
0
Poland
Query!
State/province [77]
0
0
Bydgoszcz
Query!
Country [78]
0
0
Poland
Query!
State/province [78]
0
0
Bytom
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Gdansk
Query!
Country [80]
0
0
Romania
Query!
State/province [80]
0
0
Bucharest
Query!
Country [81]
0
0
Romania
Query!
State/province [81]
0
0
Cluj Napoca
Query!
Country [82]
0
0
Romania
Query!
State/province [82]
0
0
Craiova
Query!
Country [83]
0
0
Russian Federation
Query!
State/province [83]
0
0
Moscow
Query!
Country [84]
0
0
Russian Federation
Query!
State/province [84]
0
0
St.petersburg
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
A Coruña
Query!
Country [86]
0
0
Spain
Query!
State/province [86]
0
0
Barcelona
Query!
Country [87]
0
0
Spain
Query!
State/province [87]
0
0
Madrid
Query!
Country [88]
0
0
Spain
Query!
State/province [88]
0
0
Malaga
Query!
Country [89]
0
0
Spain
Query!
State/province [89]
0
0
Valencia
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
Guildford
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
London
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Tauton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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
Query!
Trial website
https://clinicaltrials.gov/study/NCT03215706
Query!
Trial related presentations / publications
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. doi: 10.1016/S1470-2045(21)00082-6.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/06/NCT03215706/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/06/NCT03215706/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03215706
Download to PDF