Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC (CheckMate057)

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)

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

Study Overview

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

Detailed Description

CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

• Study Type: Interventional
• Enrollment (Actual): 582
• Phase: Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • Local Institution - 0011
  • La Rioja, Argentina, 5300
    • Local Institution - 0125
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, 1426
      • Local Institution - 0010
    • Capital Federal, Buenos Aires, Argentina, 1431
      • Local Institution - 0057
    • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1181ACH
      • Local Institution - 0124
• Australia
  • New South Wales
    • Tweed Heads, New South Wales, Australia, 2485
      • Local Institution
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Local Institution
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution
    • Kurralta Park, South Australia, Australia, 5037
      • Local Institution
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Local Institution
    • Melbourne, Victoria, Australia, 3065
      • Local Institution
• Austria
  • Linz, Austria, 4020
    • Local Institution
  • Salzburg, Austria, 5020
    • Local Institution
  • Vienna, Austria, 1130
    • Local Institution
  • Wels, Austria, 4600
    • Local Institution
• Brazil
  • Rio De Janeiro, Brazil, 20231-050
    • Local Institution - 0051
  • Bahia
    • Salvador, Bahia, Brazil, 40170-110
      • Local Institution - 0054
  • Ceara
    • Fortaleza, Ceara, Brazil, 60336550
      • Local Institution - 0056
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
      • Local Institution - 0053
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Local Institution - 0055
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784-400
      • Local Institution - 0052
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Local Institution - 0133
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • Local Institution
  • Quebec
    • Rimouski, Quebec, Canada, G5L 5T1
      • Local Institution - 0110
• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 7600448
      • Local Institution - 0058
    • Santiago, Metropolitana, Chile, 8420383
      • Local Institution - 0077
    • Santiago, Metropolitana, Chile
      • Local Institution - 0134
  • Valparaiso
    • Viña Del Mar, Valparaiso, Chile
      • Local Institution - 0012
• Czechia
  • Praha 8, Czechia, 180 81
    • Local Institution - 0018
• France
  • Creteil, France, 94010
    • Local Institution
  • Dijon Cedex, France, 21079
    • Local Institution
  • La Roche Sur Yon Cedex 9, France, 85925
    • Local Institution - 0119
  • Lyon Cedex 08, France, 69373
    • Local Institution - 0113
  • Marseille Cedex 20, France, 13915
    • Local Institution - 0112
  • Poitiers, France, 86000
    • Local Institution
  • Rennes Cedex 9, France, 35033
    • Local Institution - 0114
  • Toulouse, France, 31300
    • Local Institution
• Germany
  • Bad Berka, Germany, 99437
    • Local Institution
  • Grosshansdorf, Germany, 22927
    • Local Institution
  • Heidelberg, Germany, 69126
    • Local Institution
  • Koeln, Germany, 51109
    • Local Institution - 0090
  • Mainz, Germany, 55131
    • Local Institution
  • Recklinghausen, Germany, 45657
    • Local Institution
  • Stuttgart, Germany, 70376
    • Local Institution
  • Ulm, Germany, 89081
    • Local Institution
• Hong Kong
  • Hong Kong, Hong Kong
    • Local Institution
  • Hong Kong, Hong Kong
    • Local Institution - 0043
• Hungary
  • Budapest, Hungary, H-1121
    • Local Institution - 0074
• Italy
  • Bergamo, Italy, 24127
    • Local Institution - 0122
  • Bologna, Italy, 40138
    • Local Institution - 0086
  • Meldola (fc), Italy, 47014
    • Local Institution - 0087
  • Milano, Italy, 20133
    • Local Institution - 0085
  • Padova, Italy, 35128
    • Local Institution - 0084
  • Parma, Italy, 43100
    • Local Institution - 0121
  • Perugia, Italy, 06132
    • Local Institution - 0083
  • Ravenna, Italy, 48121
    • Local Institution - 0088
  • Siena, Italy, 53100
    • Local Institution - 0082
• Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06735
      • Local Institution - 0107
    • Mexico, Distrito Federal, Mexico, 14080
      • Local Institution - 0108
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64060
      • Local Institution
  • Sonora
    • Hermosillo, Sonora, Mexico, 83280
      • Local Institution
• Norway
  • Oslo, Norway, 0424
    • Local Institution - 0141
• Peru
  • Arequipa, Peru, 54
    • Local Institution - 0050
  • Lima, Peru, 34
    • Local Institution - 0048
  • Lima, Peru, L-27
    • Local Institution - 0049
  • Lima
    • Miraflores, Lima, Peru, 18
      • Local Institution - 0131
• Poland
  • Gdansk, Poland, 80-19
    • Local Institution - 0068
  • Olsztyn, Poland, 10-513
    • Local Institution - 0072
  • Szczecin, Poland, 70891
    • Local Institution - 0067
  • Warszawa, Poland, 02-781
    • Local Institution - 0070
  • Małopolskie
    • Krakow, Małopolskie, Poland, 30-002
      • Local Institution - 0073
• Romania
  • Bucuresti, Romania, 010976
    • Local Institution - 0099
  • Cluj-Napoca, Romania, 400352
    • Local Institution - 0123
  • Craiova, Romania, 200385
    • Local Institution - 0063
  • Iasi, Romania, 700106
    • Local Institution - 0061
  • Timisoara, Romania, 300167
    • Local Institution - 0062
• Russian Federation
  • Moscow, Russian Federation, 115 478
    • Local Institution - 0078
  • Moscow, Russian Federation, 115 478
    • Local Institution - 0079
  • Moscow, Russian Federation, 115 478
    • Local Institution - 0120
  • St. Petersburg, Russian Federation, 197022
    • Local Institution - 0080
• Singapore
  • Singapore, Singapore, 308433
    • Local Institution
  • Singapore, Singapore, 169610
    • Local Institution
• Spain
  • Barcelona, Spain, 08035
    • Local Institution
  • Madrid, Spain, 28050
    • Local Institution
  • Madrid, Spain, 28040
    • Local Institution
  • Sevilla, Spain, 41013
    • Local Institution - 0001
  • Vizcaya, Spain, 48903
    • Local Institution
• Switzerland
  • Basel, Switzerland, 4031
    • Local Institution
  • Chur, Switzerland, 7000
    • Local Institution
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona
  • California
    • Duarte, California, United States, 91010
      • Local Institution - 0009
    • San Diego, California, United States, 92123
      • Local Institution - 0042
    • San Francisco, California, United States, 94115
      • San Francisco Oncology Associates
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Florida
    • Tampa, Florida, United States, 33612
      • Local Institution - 0034
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Center, P.C.
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Local Institution - 0030
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0031
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0040
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0138
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • Mineola, New York, United States, 11501
      • Local Institution - 0008
    • New York, New York, United States, 10065
      • Local Institution - 0020
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Local Institution - 0027
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Local Institution - 0026
  • Pennsylvania
    • Langhorne, Pennsylvania, United States, 19047
      • St. Mary Medical Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Sayre, Pennsylvania, United States, 18840
      • Local Institution - 0035
  • South Carolina
    • Columbia, South Carolina, United States, 29210
      • Local Institution - 0025
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Local Institution - 0024
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Local Institution - 0028
  • Texas
    • Dallas, Texas, United States, 75390
      • Local Institution - 0033
    • Houston, Texas, United States, 77030
      • Local Institution - 0032
  • Washington
    • Kennewick, Washington, United States, 99336
      • Local Institution - 0041
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98109
      • Local Institution - 0007
  • West Virginia
    • Morgantown, West Virginia, United States, 26506-9162
      • Local Institution - 0019

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 & 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

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 (Anti-PD1)
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.	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	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.	Randomization until 413 deaths, up to March 2015 (approximately 29 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	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.	From randomization to date of objectively documented progression (up to approximately 110 months)
Time To Objective Response (TTOR)	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.	From randomization to the date of first confirmed response (up to approximately 110 months)
Duration of Objective Response (DOOR)	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.	From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)
Progression-Free Survival (PFS)	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.	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)
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.	Randomization to Week 12
Overall Survival (OS) by PD-L1 Expression at Baseline	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.	From randomization to the date of death or last known date alive (up to approximately 110 months)
Objective Response Rate (ORR) by PD-L1 Expression at Baseline	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.	From randomization to date of objectively documented progression (up to approximately 110 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.
• 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.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2012
• Primary Completion (ACTUAL): February 5, 2015
• Study Completion (ACTUAL): December 17, 2021

Study Registration Dates

• First Submitted: August 24, 2012
• First Submitted That Met QC Criteria: August 24, 2012
• First Posted (ESTIMATE): August 28, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

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: CA209-057; 2012-002472-14 (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