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/NCT01673867
Registration number
NCT01673867
Ethics application status
Date submitted
24/08/2012
Date registered
28/08/2012
Date last updated
8/02/2023
Titles & IDs
Public title
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC
Query!
Scientific title
An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Query!
Secondary ID [1]
0
0
2012-002472-14
Query!
Secondary ID [2]
0
0
CA209-057
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CheckMate057
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Cell 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(has expanded access)
Query!
Description of intervention(s) / exposure
Experimental: Arm A: Nivolumab - Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Active comparator: Arm B: Docetaxel - Docetaxel 75 mg/m\^2 concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
Query!
Assessment method [1]
0
0
Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.
Query!
Timepoint [1]
0
0
Randomization until 413 deaths, up to March 2015 (approximately 29 months)
Query!
Secondary outcome [1]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [1]
0
0
ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.
Query!
Timepoint [1]
0
0
From randomization to date of objectively documented progression (up to approximately 110 months)
Query!
Secondary outcome [2]
0
0
Time To Objective Response (TTOR)
Query!
Assessment method [2]
0
0
Time to Objective Response for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.
Query!
Timepoint [2]
0
0
From randomization to the date of first confirmed response (up to approximately 110 months)
Query!
Secondary outcome [3]
0
0
Duration of Objective Response (DOOR)
Query!
Assessment method [3]
0
0
DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment. Median computed using Kaplan-Meier method.
Query!
Timepoint [3]
0
0
From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)
Query!
Secondary outcome [4]
0
0
Progression-Free Survival (PFS)
Query!
Assessment method [4]
0
0
PFS was defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.
Query!
Timepoint [4]
0
0
From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)
Query!
Secondary outcome [5]
0
0
Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12
Query!
Assessment method [5]
0
0
Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.
Query!
Timepoint [5]
0
0
Randomization to Week 12
Query!
Secondary outcome [6]
0
0
Overall Survival (OS) by PD-L1 Expression at Baseline
Query!
Assessment method [6]
0
0
Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Median computed using the Kaplan-Meier method.
Query!
Timepoint [6]
0
0
From randomization to the date of death or last known date alive (up to approximately 110 months)
Query!
Secondary outcome [7]
0
0
Objective Response Rate (ORR) by PD-L1 Expression at Baseline
Query!
Assessment method [7]
0
0
ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay.
Query!
Timepoint [7]
0
0
From randomization to date of objectively documented progression (up to approximately 110 months)
Query!
Eligibility
Key inclusion criteria
* Men & women =18 years of age
* Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for advanced disease
* Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
* Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status =1
* A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient
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
* Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are asymptomatic or treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of =10mg daily prednisone (or equivalent)
* Subjects with carcinomatous meningitis
* Subjects with active or recent history of known or suspected autoimmune disease. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll
* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
* Prior therapy with anti-programmed death-1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), anti-programmed cell death ligand 2 (anti-PD-L2), anti-cluster of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
* Prior treatment with Docetaxel
* Treatment with any investigational agent within 14 days of first administration of study treatment
Other protocol-defined inclusion/exclusion criteria 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
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/11/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
17/12/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
582
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Local Institution - Tweed Heads
Query!
Recruitment hospital [2]
0
0
Local Institution - Woolloongabba
Query!
Recruitment hospital [3]
0
0
Local Institution - Adelaide
Query!
Recruitment hospital [4]
0
0
Local Institution - Kurralta Park
Query!
Recruitment hospital [5]
0
0
Local Institution - Frankston
Query!
Recruitment hospital [6]
0
0
Local Institution - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2485 - Tweed Heads
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [3]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [4]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [5]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [6]
0
0
3065 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Hampshire
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
North Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Ohio
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Pennsylvania
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
South Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Tennessee
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Texas
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Washington
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
West Virginia
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
Buenos Aires
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
La Rioja
Query!
Country [21]
0
0
Austria
Query!
State/province [21]
0
0
Linz
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Salzburg
Query!
Country [23]
0
0
Austria
Query!
State/province [23]
0
0
Vienna
Query!
Country [24]
0
0
Austria
Query!
State/province [24]
0
0
Wels
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Bahia
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Ceara
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Rio Grande Do Sul
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Sao Paulo
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Rio De Janeiro
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Alberta
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Ontario
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Quebec
Query!
Country [33]
0
0
Chile
Query!
State/province [33]
0
0
Metropolitana
Query!
Country [34]
0
0
Chile
Query!
State/province [34]
0
0
Valparaiso
Query!
Country [35]
0
0
Czechia
Query!
State/province [35]
0
0
Praha 8
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Creteil
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Dijon Cedex
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
La Roche Sur Yon Cedex 9
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Lyon Cedex 08
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Marseille Cedex 20
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Poitiers
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Rennes Cedex 9
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Toulouse
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Bad Berka
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Grosshansdorf
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Heidelberg
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Koeln
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Mainz
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Recklinghausen
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Stuttgart
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Ulm
Query!
Country [52]
0
0
Hong Kong
Query!
State/province [52]
0
0
Hong Kong
Query!
Country [53]
0
0
Hungary
Query!
State/province [53]
0
0
Budapest
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Bergamo
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Bologna
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Meldola (fc)
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Milano
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Padova
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Parma
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Perugia
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Ravenna
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Siena
Query!
Country [63]
0
0
Mexico
Query!
State/province [63]
0
0
Distrito Federal
Query!
Country [64]
0
0
Mexico
Query!
State/province [64]
0
0
Nuevo Leon
Query!
Country [65]
0
0
Mexico
Query!
State/province [65]
0
0
Sonora
Query!
Country [66]
0
0
Norway
Query!
State/province [66]
0
0
Oslo
Query!
Country [67]
0
0
Peru
Query!
State/province [67]
0
0
Lima
Query!
Country [68]
0
0
Peru
Query!
State/province [68]
0
0
Arequipa
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Malopolskie
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Gdansk
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Olsztyn
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Szczecin
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Warszawa
Query!
Country [74]
0
0
Romania
Query!
State/province [74]
0
0
Bucuresti
Query!
Country [75]
0
0
Romania
Query!
State/province [75]
0
0
Cluj-Napoca
Query!
Country [76]
0
0
Romania
Query!
State/province [76]
0
0
Craiova
Query!
Country [77]
0
0
Romania
Query!
State/province [77]
0
0
Iasi
Query!
Country [78]
0
0
Romania
Query!
State/province [78]
0
0
Timisoara
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Moscow
Query!
Country [80]
0
0
Russian Federation
Query!
State/province [80]
0
0
St. Petersburg
Query!
Country [81]
0
0
Singapore
Query!
State/province [81]
0
0
Singapore
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Barcelona
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Madrid
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Sevilla
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Vizcaya
Query!
Country [86]
0
0
Switzerland
Query!
State/province [86]
0
0
Basel
Query!
Country [87]
0
0
Switzerland
Query!
State/province [87]
0
0
Chur
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 the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy
Query!
Trial website
https://clinicaltrials.gov/study/NCT01673867
Query!
Trial related presentations / publications
Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wojcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, Garcia MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. doi: 10.1200/JCO.20.01605. Epub 2021 Jan 15. Erratum In: J Clin Oncol. 2021 Apr 1;39(10):1190. doi: 10.1200/JCO.21.00546. Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408. Reck M, Brahmer J, Bennett B, Taylor F, Penrod JR, DeRosa M, Dastani H, Spigel DR, Gralla RJ. Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. Eur J Cancer. 2018 Oct;102:23-30. doi: 10.1016/j.ejca.2018.05.005. Epub 2018 Aug 10. Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Aren Frontera O, Gettinger S, Holgado E, Spigel D, Waterhouse D, Domine M, Garassino M, Chow LQM, Blumenschein G Jr, Barlesi F, Coudert B, Gainor J, Arrieta O, Brahmer J, Butts C, Steins M, Geese WJ, Li A, Healey D, Crino L. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018 Apr 1;29(4):959-965. doi: 10.1093/annonc/mdy041. Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhaeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crino L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE. Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017 Dec 10;35(35):3924-3933. doi: 10.1200/JCO.2017.74.3062. Epub 2017 Oct 12. Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.
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
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01673867
Download to PDF