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Non-Squamous Cell Non-small Cell Lung CancerPhase 3CheckMate057NCT01673867

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

A Phase 3 study testing Nivolumab and Docetaxel in people with Non-Squamous Cell Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 119 sites in 22 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 (Nivolumab) as compared with Docetaxel in subjects with non-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
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
582 participants
Where
119 sitesin 22 countries
Study dates
2 Nov 2012to 17 Dec 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 \& 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

Who cannot join

  • 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

Trial locations and contacts

119 sites in 22 countries.

119 sites in 22 countries

United States30 sites

  • The Johns Hopkins University

    Baltimore, Maryland, 21287

  • Local Institution - 0031

    Boston, Massachusetts, 02215

  • Local Institution - 0040

    Boston, Massachusetts, 02215

  • Local Institution - 0138

    Boston, Massachusetts, 02215

  • Local Institution - 0024

    Chattanooga, Tennessee, 37404

  • Local Institution - 0030

    Chicago, Illinois, 60637

  • Local Institution - 0026

    Cincinnati, Ohio, 45242

  • Local Institution - 0025

    Columbia, South Carolina, 29210

  • Local Institution - 0033

    Dallas, Texas, 75390

  • Local Institution - 0009

    Duarte, California, 91010

  • Local Institution - 0027

    Durham, North Carolina, 27710

  • Local Institution - 0032

    Houston, Texas, 77030

  • Local Institution - 0041

    Kennewick, Washington, 99336

  • St. Mary Medical Center

    Langhorne, Pennsylvania, 19047

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Northwest Georgia Oncology Center, P.C.

    Marietta, Georgia, 30060

  • Local Institution - 0008

    Mineola, New York, 11501

  • Local Institution - 0019

    Morgantown, West Virginia, 26506-9162

  • Local Institution - 0028

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06520

  • Local Institution - 0020

    New York, New York, 10065

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Local Institution - 0042

    San Diego, California, 92123

  • San Francisco Oncology Associates

    San Francisco, California, 94115

  • Local Institution - 0035

    Sayre, Pennsylvania, 18840

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Local Institution - 0007

    Seattle, Washington, 98109

  • Local Institution - 0034

    Tampa, Florida, 33612

Other trials in United States

Italy9 sites

  • Local Institution - 0122

    Bergamo, 24127

  • Local Institution - 0086

    Bologna, 40138

  • Local Institution - 0087

    Meldola (fc), 47014

  • Local Institution - 0085

    Milan, 20133

  • Local Institution - 0084

    Padova, 35128

  • Local Institution - 0121

    Parma, 43100

  • Local Institution - 0083

    Perugia, 06132

  • Local Institution - 0088

    Ravenna, 48121

  • Local Institution - 0082

    Siena, 53100

Other trials in Italy

France8 sites

  • Local Institution

    Créteil, 94010

  • Local Institution

    Dijon, 21079

  • Local Institution - 0119

    La Roche-sur-Yon, 85925

  • Local Institution - 0113

    Lyon, 69373

  • Local Institution - 0112

    Marseille, 13915

  • Local Institution

    Poitiers, 86000

  • Local Institution - 0114

    Rennes, 35033

  • Local Institution

    Toulouse, 31300

Other trials in France

Germany8 sites

  • Local Institution

    Bad Berka, 99437

  • Local Institution - 0090

    Cologne, 51109

  • Local Institution

    Großhansdorf, 22927

  • Local Institution

    Heidelberg, 69126

  • Local Institution

    Mainz, 55131

  • Local Institution

    Recklinghausen, 45657

  • Local Institution

    Stuttgart, 70376

  • Local Institution

    Ulm, 89081

Other trials in Germany

Australia6 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Frankston, Victoria, 3199

  • Local Institution

    Kurralta Park, South Australia, 5037

  • Local Institution

    Melbourne, Victoria, 3065

  • Local Institution

    Tweed Heads, New South Wales, 2485

  • Local Institution

    Woolloongabba, Queensland, 4102

Other trials in Australia

Brazil6 sites

  • Local Institution - 0052

    Barretos, São Paulo, 14784-400

  • Local Institution - 0056

    Fortaleza, Ceará, 60336550

  • Local Institution - 0053

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Local Institution - 0055

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution - 0051

    Rio de Janeiro, 20231-050

  • Local Institution - 0054

    Salvador, Estado de Bahia, 40170-110

Other trials in Brazil

Argentina5 sites

  • Local Institution - 0011

    Buenos Aires, C1280AEB

  • Local Institution - 0010

    Capital Federal, Buenos Aires, 1426

  • Local Institution - 0057

    Capital Federal, Buenos Aires, 1431

  • Local Institution - 0124

    Ciudad de Buenos Aires, Buenos Aires, C1181ACH

  • Local Institution - 0125

    La Rioja, 5300

Other trials in Argentina

Poland5 sites

  • Local Institution - 0068

    Gdansk, 80-19

  • Local Institution - 0073

    Krakow, Lesser Poland Voivodeship, 30-002

  • Local Institution - 0072

    Olsztyn, 10-513

  • Local Institution - 0067

    Szczecin, 70891

  • Local Institution - 0070

    Warsaw, 02-781

Other trials in Poland

Romania5 sites

  • Local Institution - 0099

    Bucharest, 010976

  • Local Institution - 0123

    Cluj-Napoca, 400352

  • Local Institution - 0063

    Craiova, 200385

  • Local Institution - 0061

    Iași, 700106

  • Local Institution - 0062

    Timișoara, 300167

Other trials in Romania

Spain5 sites

  • Local Institution

    Barcelona, 08035

  • Local Institution

    Madrid, 28040

  • Local Institution

    Madrid, 28050

  • Local Institution - 0001

    Seville, 41013

  • Local Institution

    Vizcaya, 48903

Other trials in Spain

Austria4 sites

  • Local Institution

    Linz, 4020

  • Local Institution

    Salzburg, 5020

  • Local Institution

    Vienna, 1130

  • Local Institution

    Wels, 4600

Other trials in Austria

Chile4 sites

  • Local Institution - 0058

    Santiago, Santiago Metropolitan, 7600448

  • Local Institution - 0077

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0134

    Santiago, Santiago Metropolitan

  • Local Institution - 0012

    Viña del Mar, Valparaiso

Other trials in Chile

Mexico4 sites

  • Local Institution

    Hermosillo, Sonora, 83280

  • Local Institution - 0107

    Mexico City, Mexico City, 06735

  • Local Institution - 0108

    Mexico City, Mexico City, 14080

  • Local Institution

    Monterrey, Nuevo León, 64060

Other trials in Mexico

Peru4 sites

  • Local Institution - 0050

    Arequipa, 54

  • Local Institution - 0048

    Lima, 34

  • Local Institution - 0049

    Lima, L-27

  • Local Institution - 0131

    Miraflores, Lima region, 18

Other trials in Peru

Russia4 sites

  • Local Institution - 0078

    Moscow, 115 478

  • Local Institution - 0079

    Moscow, 115 478

  • Local Institution - 0120

    Moscow, 115 478

  • Local Institution - 0080

    Saint Petersburg, 197022

Other trials in Russia

Canada3 sites

  • Local Institution - 0133

    Edmonton, Alberta, T6G 1Z2

  • Local Institution

    London, Ontario, N6A 4L6

  • Local Institution - 0110

    Rimouski, Quebec, G5L 5T1

Other trials in Canada

Hong Kong2 sites

  • Local Institution - 0043

    Hong Kong, 0

  • Local Institution

    Hong Kong

Other trials in Hong Kong

Singapore2 sites

  • Local Institution

    Singapore, 169610

  • Local Institution

    Singapore, 308433

Other trials in Singapore

Switzerland2 sites

  • Local Institution

    Basel, 4031

  • Local Institution

    Chur, 7000

Other trials in Switzerland

Czechia1 site

  • Local Institution - 0018

    Prague, 180 81

Other trials in Czechia

Hungary1 site

  • Local Institution - 0074

    Budapest, H-1121

Other trials in Hungary

Norway1 site

  • Local Institution - 0141

    Oslo, 0424

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 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

Read the detailed description

CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

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 NCT01673867
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: DocetaxelActive comparatorDocetaxel 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

    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.

    Measured: Randomization until 413 deaths, up to March 2015 (approximately 29 months)

Secondary outcomes (7)

  1. 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.

    Measured: From randomization to date of objectively documented progression (up to approximately 110 months)

  2. 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.

    Measured: From randomization to the date of first confirmed response (up to approximately 110 months)

  3. 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.

    Measured: From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)

  4. 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.

    Measured: 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)

  5. 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: Randomization to Week 12

  6. 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.

    Measured: From randomization to the date of death or last known date alive (up to approximately 110 months)

  7. 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.

    Measured: From randomization to date of objectively documented progression (up to approximately 110 months)

Timeline

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

  1. First posted28 Aug 2012 (estimated)
  2. Study start2 Nov 2012
  3. Primary completion5 Feb 2015
  4. Study completion17 Dec 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
582 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01673867
Sponsor's protocol ID
CA209-057
Other IDs
2012-002472-14
Acronym
CheckMate057
Status last verified
Jan 2023
First submitted
24 Aug 2012
Last updated
8 Feb 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Barrera C, Corredor G, Viswanathan VS, Ding R, Toro P, Fu P, Buzzy C, Lu C, Velu P, Zens P, Berezowska S, Belete M, Balli D, Chang H, Baxi V, Syrigos K, Rimm DL, Velcheti V, Schalper K, Romero E, Madabhushi A. Deep computational image analysis of immune cell niches reveals treatment-specific outcome associations in lung cancer. NPJ Precis Oncol. 2023 Jun 1;7(1):52. doi: 10.1038/s41698-023-00403-x.

    PubMed 37264091

  • 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

  • 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

  • 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.

    PubMed 30103096

  • 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

  • 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.

    PubMed 26412456

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab and Docetaxel in people with Non-Squamous Cell Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 119 sites in 22 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 8 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Italy, France, Germany, Australia and 17 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 26 Feb 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 413 deaths, up to March 2015 (approximately 29 months)). 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 NCT01673867, 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 8 Feb 2023.

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