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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/NCT02041533
Registration number
NCT02041533
Ethics application status
Date submitted
19/01/2014
Date registered
22/01/2014
Date last updated
2/03/2023
Titles & IDs
Public 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)
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Scientific 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
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Secondary ID [1]
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2012-004502-93
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Secondary ID [2]
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CA209-026
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stage IV or Recurrent Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pemetrexed
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
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
Other interventions: Nivolumab
Treatment: Drugs: Gemcitabine
Treatment: Drugs: Cisplatin
Treatment: Drugs: Carboplatin
Treatment: Drugs: Paclitaxel
Treatment: Drugs: Pemetrexed
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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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Progression-Free Survival in Participants With PD-L1 Expression >= 5%
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Assessment method [1]
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Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die 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 day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
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Timepoint [1]
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From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
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Secondary outcome [1]
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Progression-Free Survival in All Randomized Participants
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Assessment method [1]
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Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die 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 day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
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Timepoint [1]
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From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
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Secondary outcome [2]
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Overall Survival in Participants With PD-L1 Expression >= 5%
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Assessment method [2]
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Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
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Timepoint [2]
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From date of randomization to date of death (up to approximately 89 months)
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Secondary outcome [3]
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Overall Survival in All Randomized Participants
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Assessment method [3]
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Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
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Timepoint [3]
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From date of randomization to date of death (up to approximately 89 months)
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Secondary outcome [4]
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Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
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Assessment method [4]
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ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.
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Timepoint [4]
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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 August 2016, approximately 28 months)
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Secondary outcome [5]
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Disease-related Symptom Improvement Rate by Week 12
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Assessment method [5]
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The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.
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Timepoint [5]
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From date of randomization to week 12
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Eligibility
Key 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
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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
- 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
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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
Completed
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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
27/03/2014
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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
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Actual
27/05/2022
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Sample size
Target
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Accrual to date
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Final
541
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Local Institution - 0090 - Camperdown
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Local Institution - 0091 - Brisbane
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Local Institution - 0071 - Elizabeth Vale
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Local Institution - 0072 - Fitzroy
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Local Institution - 0104 - Heidelberg
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2050 - Camperdown
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4102 - Brisbane
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5112 - Elizabeth Vale
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment outside Australia
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Greater Manchester
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Country [109]
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United Kingdom
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State/province [109]
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Yorkshire
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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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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Ono Pharmaceutical Co. Ltd
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Address [1]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02041533
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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 public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02041533
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