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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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
Secondary ID [1] 0 0
2012-004502-93
Secondary ID [2] 0 0
CA209-026
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage IV or Recurrent Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival in Participants With PD-L1 Expression >= 5%
Timepoint [1] 0 0
From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Secondary outcome [1] 0 0
Progression-Free Survival in All Randomized Participants
Timepoint [1] 0 0
From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Secondary outcome [2] 0 0
Overall Survival in Participants With PD-L1 Expression >= 5%
Timepoint [2] 0 0
From date of randomization to date of death (up to approximately 89 months)
Secondary outcome [3] 0 0
Overall Survival in All Randomized Participants
Timepoint [3] 0 0
From date of randomization to date of death (up to approximately 89 months)
Secondary outcome [4] 0 0
Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Disease-related Symptom Improvement Rate by Week 12
Timepoint [5] 0 0
From date of randomization to week 12

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/05/2022
Sample size
Target
Accrual to date
Final
541
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0090 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0091 - Brisbane
Recruitment hospital [3] 0 0
Local Institution - 0071 - Elizabeth Vale
Recruitment hospital [4] 0 0
Local Institution - 0072 - Fitzroy
Recruitment hospital [5] 0 0
Local Institution - 0104 - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment outside Australia
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Chur
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Greater London
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Greater Manchester
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Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT02041533
Trial related presentations / publications
Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02041533