AzTrials
AzTrials

Squamous Cell Non-small Cell Lung CancerPhase 3NCT01642004

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

A Phase 3 study testing Nivolumab and Docetaxel in people with Squamous Cell Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 127 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Non-small Cell Lung Cancer
What is being tested?
Nivolumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
127 sitesin 21 countries
Study dates
16 Oct 2012to 16 Aug 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

127 sites in 21 countries.

127 sites in 21 countries

United States39 sites

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • Local Institution - 0003

    Baltimore, Maryland, 21287

  • Local Institution - 0036

    Boston, Massachusetts, 02114

  • Local Institution - 0084

    Boston, Massachusetts, 02114

  • Local Institution - 0150

    Boston, Massachusetts, 02114

  • Local Institution - 0087

    Chattanooga, Tennessee, 37404

  • Local Institution - 0100

    Chicago, Illinois, 60637

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Local Institution - 0082

    Columbia, South Carolina, 29210

  • Local Institution - 0012

    Dallas, Texas, 75390

  • University Of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • City Of Hope

    Duarte, California, 91010-3000

  • Local Institution - 0020

    Duarte, California, 91010-3000

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Local Institution - 0008

    Durham, North Carolina, 27710

  • Local Institution - 0086

    Houston, Texas, 77030

  • St Mary Medical Center

    Langhorne, Pennsylvania, 19047

  • Local Institution - 0153

    Marietta, Georgia, 30060

  • Local Institution - 0016

    Mineola, New York, 11501

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Local Institution - 0033

    Morgantown, West Virginia, 26506-9162

  • Local Institution - 0005

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Local Institution - 0032

    Nashville, Tennessee, 37232

  • Local Institution - 0009

    New Haven, Connecticut, 06520

  • Yale University

    New Haven, Connecticut, 06520

  • Columbia University Medical Center

    New York, New York, 10032

  • Local Institution - 0006

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau

    New York, New York, 10065

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Local Institution - 0011

    Philadelphia, Pennsylvania, 19111

  • Guthrie Medical Group, Pc

    Sayre, Pennsylvania, 18840

  • Mayo Clinic in Arizona - Scottsdale

    Scottsdale, Arizona, 85259

  • Local Institution - 0017

    Seattle, Washington, 98104

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Local Institution - 0001

    Seattle, Washington, 98109

  • University of Washington - Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • Local Institution - 0004

    Tampa, Florida, 33612

Other trials in United States

France14 sites

  • Local Institution - 0053

    Avignon Cedes 9, 84918

  • Local Institution - 0156

    Caen, 14000

  • Local Institution - 0025

    Dijon, 21000

  • Local Institution

    Dijon, 21000

  • Local Institution - 0093

    La Roche-sur-Yon, 85925

  • Local Institution - 0022

    Lyon, 69373

  • Local Institution

    Lyon, 69373

  • Local Institution - 0023

    Marseille, 13915

  • Local Institution

    Marseille, 13915

  • Local Institution - 0160

    Pierre-Bénite, 69495

  • Local Institution - 0027

    Rennes, 35033

  • Local Institution

    Rennes, 35033

  • Local Institution - 0157

    Strasbourg, 67090

  • Local Institution - 0040

    Toulouse, 31300

Other trials in France

Germany7 sites

  • Local Institution - 0064

    Bad Berka, 99437

  • Local Institution - 0063

    Cologne, 51109

  • Local Institution - 0105

    Essen, 45122

  • Local Institution - 0109

    Gerlingen, 70839

  • Local Institution - 0048

    Großhansdorf, 22927

  • Local Institution - 0065

    Heidelberg, 69126

  • Local Institution - 0162

    Krefeld, 47805

Other trials in Germany

Italy7 sites

  • Local Institution - 0058

    Bologna, 40138

  • Local Institution - 0088

    Meldola (fc), 47014

  • Local Institution - 0057

    Milan, 20133

  • Local Institution - 0056

    Padova, 35128

  • Local Institution - 0055

    Perugia, 06132

  • Local Institution - 0089

    Ravenna, 48121

  • Local Institution - 0054

    Siena, 53100

Other trials in Italy

Romania6 sites

  • Local Institution - 0136

    Bucharest, 010976

  • Local Institution - 0145

    Cluj-Napoca, 400352

  • Local Institution - 0138

    Constanța, 900591

  • Local Institution - 0121

    Craiova, 200385

  • Local Institution - 0119

    Iași, 700106

  • Local Institution - 0120

    Timișoara, 300167

Other trials in Romania

Argentina5 sites

  • Local Institution - 0071

    Buenos Aires, C1280AEB

  • Local Institution - 0116

    Capital Federal, Buenos Aires, 1431

  • Local Institution - 0072

    Ciudad Autónoma de Buenos Aire, Buenos Aires, CP1426ANZ

  • Local Institution - 0141

    Córdoba, X5002AOQ

  • Local Institution - 0164

    San Miguel de Tucumán, Tucumán Province, CPT4000IAK

Other trials in Argentina

Australia5 sites

  • Local Institution - 0159

    Adelaide, South Australia, 5000

  • Local Institution - 0085

    Clayton, Victoria, 3168

  • Local Institution - 0140

    Elizabeth Vale, South Australia, 5112

  • Local Institution - 0158

    Kurralta Park, South Australia, 5037

  • Local Institution - 0073

    Wollongong, New South Wales, 2500

Other trials in Australia

Chile5 sites

  • Local Institution - 0161

    Antofagasta, 240000

  • Local Institution - 0117

    Santiago, Santiago Metropolitan, 7600448

  • Local Institution - 0131

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0154

    Santiago, 7630370

  • Local Institution - 0110

    Viña del Mar, Valparaiso

Other trials in Chile

Poland5 sites

  • Local Institution - 0126

    Gdansk, 80-952

  • Local Institution - 0130

    Krakow, 31-202

  • Local Institution - 0129

    Olsztyn, 10-513

  • Local Institution - 0124

    Szczecin, 70-891

  • Local Institution - 0127

    Warsaw, 02-781

Other trials in Poland

Spain5 sites

  • Local Institution - 0044

    Barakaldo, Vizcaya, 48903

  • Local Institution - 0042

    Barcelona, 08035

  • Local Institution - 0046

    Madrid, 28040

  • Local Institution - 0045

    Madrid, 28050

  • Local Institution - 0041

    Seville, 41013

Other trials in Spain

Austria4 sites

  • Local Institution - 0102

    Linz, 4020

  • Local Institution - 0104

    Salzburg, 5020

  • Local Institution - 0049

    Vienna, 1130

  • Local Institution - 0103

    Wels, 4600

Other trials in Austria

Mexico4 sites

  • Local Institution - 0139

    Hermosillo, Sonora, 83280

  • Local Institution - 0106

    Leon, Guanajato, Guanajuato, 37000

  • Local Institution - 0107

    Mexico City, Mexico City, 06735

  • Local Institution - 0108

    Mexico City, Mexico City, 14080

Other trials in Mexico

Russia4 sites

  • Local Institution - 0132

    Moscow, 115 478

  • Local Institution - 0133

    Moscow, 115 478

  • Local Institution - 0144

    Moscow, 115 478

  • Local Institution - 0135

    Saint Petersburg, 198255

Other trials in Russia

United Kingdom4 sites

  • Local Institution - 0047

    Cottingham, East Yorkshire, HU16 5JQ

  • Local Institution - 0037

    Sheffield, Yorkshire, S10 2SJ

  • Local Institution - 0034

    Southampton, Hampshire, SO16 6YD

  • Local Institution - 0163

    Withington, Manchester, M20 4BX

Other trials in United Kingdom

Canada3 sites

  • Local Institution - 0147

    Montreal, Quebec, H3T 1E2

  • Local Institution - 0152

    Rimouski, Quebec, G5L 5T1

  • Local Institution - 0146

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Hungary2 sites

  • Local Institution - 0095

    Budapest, H-1121

  • Local Institution - 0096

    Budapest, H-1121

Other trials in Hungary

Ireland2 sites

  • Local Institution - 0035

    Dublin, Dublin

  • Local Institution - 0039

    Dublin, Dublin

Other trials in Ireland

Netherlands2 sites

  • Local Institution - 0052

    Amsterdam, 1066 CX

  • Local Institution - 0051

    Rotterdam, 3000 CA

Other trials in Netherlands

Peru2 sites

  • Local Institution - 0099

    Arequipa, 54

  • Local Institution - 0061

    Lima, 34

Other trials in Peru

Czechia1 site

  • Local Institution - 0111

    Prague, 180 81

Other trials in Czechia

Norway1 site

  • Local Institution - 0143

    Oslo, 0310

Other trials in Norway

About this study

Official title: 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.

Being tested
Nivolumab, Docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01642004
Study groupRoleWhat they receive
Arm A: NivolumabExperimentalNivolumab 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.
Receives: Biological: Nivolumab
Arm B: DocetaxelExperimentalDocetaxel 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.
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Randomization until 199 deaths, up to November 2014, approximately 25 months

  2. 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.

    Measured: Randomization to 18 months post-randomization, up to June 2015

  3. 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.

    Measured: Randomization until 199 deaths, up to November 2014, approximately 25 months

Secondary outcomes (9)

  1. 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.

    Measured: From the date of randomization up to the date of objectively documented progression, up to approximately 103 months

  2. 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.

    Measured: From the date of randomization to the date of the first confirmed response, up to approximately 12 months

  3. 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.

    Measured: 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

  4. 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.

    Measured: From randomization to specified timepoints, up to 84 months

  5. 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.

    Measured: 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

  6. 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.

    Measured: From randomization up to Week 12

  7. 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.

    Measured: From the date of randomization to the date of death from any cause, up to approximately 103 months

  8. 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.

    Measured: From the date of randomization up to the date of objectively documented progression, up to approximately 103 months

  9. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2012 (estimated)
  2. Study start16 Oct 2012
  3. Primary completion17 Nov 2014
  4. Study completion16 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01642004
Sponsor's protocol ID
CA209-017
Other IDs
2011-004792-36
Status last verified
Nov 2022
First submitted
9 Jul 2012
Last updated
28 Dec 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Shin E, Bhat AG, Ramanathan M. Large Language Models for Clinical Trial Protocol Assessments. Clin Pharmacol Ther. 2026 Feb;119(2):393-402. doi: 10.1002/cpt.70096. Epub 2025 Oct 21.

    PubMed 41121745

  • Hu S, Tang Z, Harrison JP, Hertel N, Penrod JR, May JR, Juarez-Garcia A, Holdgate O. Economic Evaluation of Nivolumab Versus Docetaxel for the Treatment of Advanced Squamous and Non-squamous Non-small Cell Lung Cancer After Prior Chemotherapy in China. Pharmacoecon Open. 2023 Mar;7(2):273-284. doi: 10.1007/s41669-022-00383-x. Epub 2023 Mar 10.

    PubMed 36897427

  • 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.

    PubMed 33449799

  • 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.

    PubMed 32198149

  • 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.

    PubMed 30215677

  • 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.

    PubMed 29408986

  • 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.

    PubMed 29023213

  • 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.

    PubMed 26028407

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab and Docetaxel in people with Squamous Cell Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 127 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, France, Germany, Italy, Romania and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (time frame: Randomization until 199 deaths, up to November 2014, approximately 25 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01642004, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in