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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2017-001195-35
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Secondary ID [2]
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CA209-9LA
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 9LA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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0
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Lung - Mesothelioma
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Cancer
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0
0
0
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Lung - Non small cell
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Cancer
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0
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Ipilimumab
Other interventions - 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
Other interventions: Ipilimumab
Specified dose on specified day
Other interventions: 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
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
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Secondary outcome [1]
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Progression Free Survival (PFS) by BICR
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Assessment method [1]
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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.
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Timepoint [1]
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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)
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Secondary outcome [2]
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Objective Response Rate (ORR) by BICR
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Assessment method [2]
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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.
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Timepoint [2]
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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)
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Secondary outcome [3]
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Duration of Response (DoR)
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Assessment method [3]
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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.
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Timepoint [3]
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From date of first confirmed response to date of tumor progression (assessed up to October 2019, approximately 23 months)
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Secondary outcome [4]
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Time to Response (TTR)
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Assessment method [4]
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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.
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Timepoint [4]
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From date of randomization to date of first confirmed documented response (assessed up to October 2019, approximately 23 months)
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Secondary outcome [5]
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Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
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Assessment method [5]
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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%
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Timepoint [5]
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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)
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Secondary outcome [6]
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PFS by BICR by PD-L1 Tumor Cell Expression
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Assessment method [6]
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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.
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Timepoint [6]
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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)
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Secondary outcome [7]
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OS by PD-L1 Tumor Cell Expression
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Assessment method [7]
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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.
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Timepoint [7]
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From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/08/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
19/01/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
719
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0086 - Gosford
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Local Institution - 0040 - Bedford Park
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Local Institution - 0089 - Box Hill
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Local Institution - 0036 - Heidelberg
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Local Institution - 0078 - Murdoch
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2250 - Gosford
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5042 - Bedford Park
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3128 - Box Hill
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3084 - Heidelberg
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6150 - Murdoch
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Recruitment outside Australia
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United States of America
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Colorado
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Tauton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03215706
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03215706
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