Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.

Study Overview

• Status: Completed
• Conditions: Squamous Cell Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Biological: Nivolumab

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • Local Institution - 0071
  • Cordoba, Argentina, X5002AOQ
    • Local Institution - 0141
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, 1431
      • Local Institution - 0116
    • Ciudad Autónoma De Buenos Aire, Buenos Aires, Argentina, CP1426ANZ
      • Local Institution - 0072
  • Tucuman
    • San Miguel De Tucuman, Tucuman, Argentina, CPT4000IAK
      • Local Institution - 0164
• Australia
  • New South Wales
    • Wollongong, New South Wales, Australia, 2500
      • Local Institution - 0073
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution - 0159
    • Elizabeth Vale, South Australia, Australia, 5112
      • Local Institution - 0140
    • Kurralta Park, South Australia, Australia, 5037
      • Local Institution - 0158
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Local Institution - 0085
• Austria
  • Linz, Austria, 4020
    • Local Institution - 0102
  • Salzburg, Austria, 5020
    • Local Institution - 0104
  • Vienna, Austria, 1130
    • Local Institution - 0049
  • Wels, Austria, 4600
    • Local Institution - 0103
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Local Institution - 0146
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Local Institution - 0147
    • Rimouski, Quebec, Canada, G5L 5T1
      • Local Institution - 0152
• Chile
  • Antofagasta, Chile, 240000
    • Local Institution - 0161
  • Santiago, Chile, 7630370
    • Local Institution - 0154
  • Metropolitana
    • Santiago, Metropolitana, Chile, 8420383
      • Local Institution - 0131
    • Santiago, Metropolitana, Chile, 7600448
      • Local Institution - 0117
  • Valparaiso
    • Viña Del Mar, Valparaiso, Chile
      • Local Institution - 0110
• Czechia
  • Praha 8, Czechia, 180 81
    • Local Institution - 0111
• France
  • Avignon Cedes 9, France, 84918
    • Local Institution - 0053
  • Caen, France, 14000
    • Local Institution - 0156
  • Dijon, France, 21000
    • Local Institution
  • Dijon, France, 21000
    • Local Institution - 0025
  • La Roche Sur Yon Cedex 9, France, 85925
    • Local Institution - 0093
  • Lyon Cedex 08, France, 69373
    • Local Institution
  • Lyon Cedex 08, France, 69373
    • Local Institution - 0022
  • Marseille Cedex 20, France, 13915
    • Local Institution
  • Marseille Cedex 20, France, 13915
    • Local Institution - 0023
  • Pierre Benite, France, 69495
    • Local Institution - 0160
  • Rennes Cedex 9, France, 35033
    • Local Institution
  • Rennes Cedex 9, France, 35033
    • Local Institution - 0027
  • Strasbourg, France, 67090
    • Local Institution - 0157
  • Toulouse, France, 31300
    • Local Institution - 0040
• Germany
  • Bad Berka, Germany, 99437
    • Local Institution - 0064
  • Essen, Germany, 45122
    • Local Institution - 0105
  • Gerlingen, Germany, 70839
    • Local Institution - 0109
  • Grosshansdorf, Germany, 22927
    • Local Institution - 0048
  • Heidelberg, Germany, 69126
    • Local Institution - 0065
  • Koeln, Germany, 51109
    • Local Institution - 0063
  • Krefeld, Germany, 47805
    • Local Institution - 0162
• Hungary
  • Budapest, Hungary, H-1121
    • Local Institution - 0095
  • Budapest, Hungary, H-1121
    • Local Institution - 0096
• Ireland
  • Dublin
    • Dublin 8, Dublin, Ireland
      • Local Institution - 0039
    • Dublin 9, Dublin, Ireland
      • Local Institution - 0035
• Italy
  • Bologna, Italy, 40138
    • Local Institution - 0058
  • Meldola (fc), Italy, 47014
    • Local Institution - 0088
  • Milano, Italy, 20133
    • Local Institution - 0057
  • Padova, Italy, 35128
    • Local Institution - 0056
  • Perugia, Italy, 06132
    • Local Institution - 0055
  • Ravenna, Italy, 48121
    • Local Institution - 0089
  • Siena, Italy, 53100
    • Local Institution - 0054
• Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06735
      • Local Institution - 0107
    • Mexico, Distrito Federal, Mexico, 14080
      • Local Institution - 0108
  • Guanajuato
    • Leon, Guanajato, Guanajuato, Mexico, 37000
      • Local Institution - 0106
  • Sonora
    • Hermosillo, Sonora, Mexico, 83280
      • Local Institution - 0139
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Local Institution - 0052
  • Rotterdam, Netherlands, 3000 CA
    • Local Institution - 0051
• Norway
  • Oslo, Norway, 0310
    • Local Institution - 0143
• Peru
  • Arequipa, Peru, 54
    • Local Institution - 0099
  • Lima, Peru, 34
    • Local Institution - 0061
• Poland
  • Gdansk, Poland, 80-952
    • Local Institution - 0126
  • Krakow, Poland, 31-202
    • Local Institution - 0130
  • Olsztyn, Poland, 10-513
    • Local Institution - 0129
  • Szczecin, Poland, 70-891
    • Local Institution - 0124
  • Warszawa, Poland, 02-781
    • Local Institution - 0127
• Romania
  • Bucuresti, Romania, 010976
    • Local Institution - 0136
  • Cluj-Napoca, Romania, 400352
    • Local Institution - 0145
  • Constanta, Romania, 900591
    • Local Institution - 0138
  • Craiova, Romania, 200385
    • Local Institution - 0121
  • Iasi, Romania, 700106
    • Local Institution - 0119
  • Timisoara, Romania, 300167
    • Local Institution - 0120
• Russian Federation
  • Moscow, Russian Federation, 115 478
    • Local Institution - 0132
  • Moscow, Russian Federation, 115 478
    • Local Institution - 0133
  • Moscow, Russian Federation, 115 478
    • Local Institution - 0144
  • St. Petersburg, Russian Federation, 198255
    • Local Institution - 0135
• Spain
  • Barcelona, Spain, 08035
    • Local Institution - 0042
  • Madrid, Spain, 28040
    • Local Institution - 0046
  • Madrid, Spain, 28050
    • Local Institution - 0045
  • Sevilla, Spain, 41013
    • Local Institution - 0041
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • Local Institution - 0044
• United Kingdom
  • East Yorkshire
    • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
      • Local Institution - 0047
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Local Institution - 0034
  • Manchester
    • Withington, Manchester, United Kingdom, M20 4BX
      • Local Institution - 0163
  • Yorkshire
    • Sheffield, Yorkshire, United Kingdom, S10 2SJ
      • Local Institution - 0037
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona - Scottsdale
  • California
    • Duarte, California, United States, 91010-3000
      • City of Hope
    • Duarte, California, United States, 91010-3000
      • Local Institution - 0020
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
    • New Haven, Connecticut, United States, 06520
      • Local Institution - 0009
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center
    • Tampa, Florida, United States, 33612
      • Local Institution - 0004
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Local Institution - 0153
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Local Institution - 0100
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Baltimore, Maryland, United States, 21287
      • Local Institution - 0003
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Local Institution - 0036
    • Boston, Massachusetts, United States, 02114
      • Local Institution - 0084
    • Boston, Massachusetts, United States, 02114
      • Local Institution - 0150
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • Mineola, New York, United States, 11501
      • Local Institution - 0016
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Nassau
    • New York, New York, United States, 10065
      • Local Institution - 0006
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27710
      • Local Institution - 0008
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care, Inc.
  • Pennsylvania
    • Langhorne, Pennsylvania, United States, 19047
      • St Mary Medical Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Local Institution - 0011
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group, PC
  • South Carolina
    • Columbia, South Carolina, United States, 29210
      • Local Institution - 0082
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Local Institution - 0087
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Local Institution - 0005
    • Nashville, Tennessee, United States, 37232
      • Local Institution - 0032
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75390
      • Local Institution - 0012
    • Houston, Texas, United States, 77030
      • Local Institution - 0086
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98109
      • University of Washington - Seattle Cancer Care Alliance
    • Seattle, Washington, United States, 98104
      • Local Institution - 0017
    • Seattle, Washington, United States, 98109
      • Local Institution - 0001
  • West Virginia
    • Morgantown, West Virginia, United States, 26506-9162
      • Local Institution - 0033

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women ≥18 years of age
• Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally 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 Response Evaluation Criteria in Solid Tumors (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

Exclusion Criteria:

• Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are 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 ≤10 mg daily prednisone (or equivalent)
• Subjects with carcinomatous meningitis
• Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger 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 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
• Prior treatment on the first line study CA184104 first line NSCLC study
• Prior treatment with Docetaxel
• Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
• Treatment with any investigational agent within 14 days of first administration of study treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Biological: Nivolumab; Other Names: BMS-936558
Experimental: 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.	Drug: Docetaxel; Other Names: Taxotere®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint	OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.	Randomization until 199 deaths, up to November 2014, approximately 25 months
Overall Survival (OS) Rate in All Randomized Participants	The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.	Randomization to 18 months post-randomization, up to June 2015
Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint	The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.	Randomization until 199 deaths, up to November 2014, approximately 25 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) in All Randomized Participants	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). 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. CIs were computed using the Clopper and Pearson method.	From the date of randomization up to the date of objectively documented progression, up to approximately 103 months
Time To Response (TTR) in Months for All Confirmed Responders	Time to Response (TTR) 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.	From the date of randomization to the date of the first confirmed response, up to approximately 12 months
Duration of Objective Response (DOR) in Months for All Confirmed Responders	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.	From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 94 months
Progression Free Survival Rate (PFSR)	PFSR was defined as the percentage of participants who did not experience disease progression or death from any cause at a given time point following randomization. Progression was assessed by investigators according to RECIST v1.1. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative radiation therapy (RT) of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.	From randomization to specified timepoints, up to 84 months
Progression-Free Survival (PFS) Time in Months for All Randomized Participants	PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. The PFS curves were estimated using KM method. Two-sided 95% CI for median PFS were computed by Brookmeyer and Crowley method (using log-log transformation). Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative RT of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.	From randomization up to the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 months
Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12	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.	From randomization up to Week 12
Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants	OS was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method.	From the date of randomization to the date of death from any cause, up to approximately 103 months
Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants	ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. 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). 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. 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. CIs were computed using the Clopper and Pearson method.	From the date of randomization up to the date of objectively documented progression, up to approximately 103 months
Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants	PFS time was measured for all randomized participants grouped by their baseline PD-L1 expression levels. PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. The PFS curves were estimated using KM method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy (including on-treatment palliative radiotherapy of non-target bone lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to subsequent anti-cancer therapy.	From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time in Months for All Randomized Participants at Updated Survival Follow-up	OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Survival follow-up analysis occurred 7.4 months after Primary Endpoint was reached, representing a minimum OS follow-up time of 18.0 months.	Randomization until July 2015, approximately 33 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General 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.
• Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.
• 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.
• 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.
• Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Aren Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2012
• Primary Completion (Actual): November 17, 2014
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 17, 2012

Study Record Updates

• Last Update Posted (Estimate): December 28, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Docetaxel; Nivolumab
• Other Study ID Numbers: CA209-017; 2011-004792-36 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No