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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02041533




Registration number
NCT02041533
Ethics application status
Date submitted
19/01/2014
Date registered
22/01/2014
Date last updated
8/07/2020

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

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival in Participants With PD-L1 Expression >= 5% - 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.
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 - 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.
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% - 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.
Timepoint [2] 0 0
From date of randomization to date of death (assessed up to August 2016, approximately 28 months)
Secondary outcome [3] 0 0
Overall Survival in All Randomized Participants - 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.
Timepoint [3] 0 0
From date of randomization to date of death (assessed up to August 2016, approximately 28 months)
Secondary outcome [4] 0 0
Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5% - 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.
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
Duration of Response in Participants With PD-L1 Expression>= 5% - Duration of Response (DOR) was summarized for participants with objective response and was defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression as determined by IRRC assessment (per RECIST v1.1) or death due to any cause, whichever occurs first. DOR censoring rules were the same as the PFS primary definition. 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
Timepoint [5] 0 0
From date of first confirmed response to date of tumor progression (Assessed up to August 2016, approximately 28 months)
Secondary outcome [6] 0 0
Time to Response in Participants With PD-L1 Expression >= 5% - Time to Response (TTR) was defined as the time from randomization to the date of the first response (CR or PR), as assessed by IRRC assessment. TTR was evaluated for responders only. 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.
Timepoint [6] 0 0
From date of randomization to date of first confirmed response (assessed up to August 2016, approximately 18 months)
Secondary outcome [7] 0 0
Disease-related Symptom Improvement Rate by Week 12 - 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.
Timepoint [7] 0 0
From date of randomization to week 12

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- 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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Brisbane
Recruitment hospital [3] 0 0
Local Institution - Elizabeth Vale
Recruitment hospital [4] 0 0
Local Institution - Fitzroy
Recruitment hospital [5] 0 0
Local Institution - 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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Austria
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Wels
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Brazil
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RIO Grande DO SUL
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Brazil
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SAO Paulo
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Canada
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Alberta
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Ontario
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Quebec
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Canada
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Montreal
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Olomouc
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Czechia
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Ostrava - Poruba
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Praha 8
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Czechia
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Usti nad Labem
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Finland
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Helsinki
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Finland
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Tampere
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Finland
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Vaasa
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France
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Caen
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France
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Lille
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France
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Marseille Cedex 20
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France
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Pontoise Cedex
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France
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Rennes Cedex 9
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France
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Strasbourg
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Germany
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Bamberg
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Germany
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Gerlingen
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Germany
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Grosshansdorf
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Germany
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Heidelberg
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Germany
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Koeln
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Germany
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Wiesbaden
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Greece
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Creta
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Greece
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Athens
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Matrahaza
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Italy
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Avellino
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Italy
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Livorno
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Italy
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Milano
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Italy
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Napoli
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Italy
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Perugia
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Italy
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Terni
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Japan
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Aichi
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Ehime
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Hyogo
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Miyagi
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Niigata
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Osaka
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Saitama
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Japan
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Shizuoka
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Tokyo
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Akashi, Hyogo
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Ota, Gunma
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Japan
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Sapporo, Hokkaido
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Japan
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Wakayama
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Yucatan
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Rotterdam
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Poland
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Bydgoszcz
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Poland
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Krakow
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Poland
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Lodz
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Poland
State/province [89] 0 0
Warszawa
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Poland
State/province [90] 0 0
Wodzislaw Slaski
Country [91] 0 0
Romania
State/province [91] 0 0
Cluj Napoca
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Romania
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Cluj-napoca
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Romania
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Ploiesti
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Spain
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Barcelona
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Spain
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Las Palmas De Gran Canaria
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Spain
State/province [99] 0 0
Valencia
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Sweden
State/province [100] 0 0
Stockholm
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Sweden
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Uppsala
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Switzerland
State/province [102] 0 0
Chur
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Switzerland
State/province [103] 0 0
Lausanne
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Switzerland
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Zuerich
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Taiwan
State/province [105] 0 0
Taipei
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Turkey
State/province [106] 0 0
Kayseri
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United Kingdom
State/province [107] 0 0
Greater London
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United Kingdom
State/province [108] 0 0
Greater Manchester
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United Kingdom
State/province [109] 0 0
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/show/NCT02041533
Trial related presentations / publications
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
Other publications