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

Primary Purpose

Non-Squamous Cell Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Docetaxel

About this trial

This is an interventional treatment trial for Non-Squamous Cell Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Nivolumab

Arm B: Docetaxel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT01673867

First Posted

August 24, 2012

Last Updated

January 13, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01673867

Brief Title

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

Acronym

CheckMate057

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

November 2, 2012 (Actual)

Primary Completion Date

February 5, 2015 (Actual)

Study Completion Date

December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Squamous Cell Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

582 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Nivolumab

Arm Type

Experimental

Arm Description

Arm Title

Arm B: Docetaxel

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

BMS-936558 (Anti-PD1)

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere®

Primary Outcome Measure Information:

Title

Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Time Frame

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

Title

Time To Objective Response (TTOR)

Description

Time Frame

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

Title

Duration of Objective Response (DOOR)

Description

Time Frame

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

Title

Progression-Free Survival (PFS)

Description

Time Frame

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)

Title

Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12

Description

Time Frame

Randomization to Week 12

Title

Overall Survival (OS) by PD-L1 Expression at Baseline

Description

Time Frame

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

Title

Objective Response Rate (ORR) by PD-L1 Expression at Baseline

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Mayo Clinic Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

Local Institution - 0009

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Local Institution - 0042

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

San Francisco Oncology Associates

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Local Institution - 0034

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Northwest Georgia Oncology Center, P.C.

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Local Institution - 0030

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

The Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Local Institution - 0031

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0040

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0138

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Dartmouth-Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Local Institution - 0008

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Local Institution - 0020

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Local Institution - 0027

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Local Institution - 0026

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

St. Mary Medical Center

City

Langhorne

State/Province

Pennsylvania

ZIP/Postal Code

19047

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

Local Institution - 0035

City

Sayre

State/Province

Pennsylvania

ZIP/Postal Code

18840

Country

United States

Facility Name

Local Institution - 0025

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29210

Country

United States

Facility Name

Local Institution - 0024

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Local Institution - 0028

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Local Institution - 0033

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Local Institution - 0032

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Local Institution - 0041

City

Kennewick

State/Province

Washington

ZIP/Postal Code

99336

Country

United States

Facility Name

Swedish Cancer Institute

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Local Institution - 0007

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Local Institution - 0019

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506-9162

Country

United States

Facility Name

Local Institution - 0010

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

Local Institution - 0057

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1431

Country

Argentina

Facility Name

Local Institution - 0124

City

Ciudad De Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Local Institution - 0011

City

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Local Institution - 0125

City

La Rioja

ZIP/Postal Code

5300

Country

Argentina

Facility Name

Local Institution

City

Tweed Heads

State/Province

New South Wales

ZIP/Postal Code

2485

Country

Australia

Facility Name

Local Institution

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Local Institution

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Local Institution

City

Kurralta Park

State/Province

South Australia

ZIP/Postal Code

5037

Country

Australia

Facility Name

Local Institution

City

Frankston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

Local Institution

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Local Institution

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Local Institution

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Local Institution

City

Vienna

ZIP/Postal Code

1130

Country

Austria

Facility Name

Local Institution

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Local Institution - 0054

City

Salvador

State/Province

Bahia

ZIP/Postal Code

40170-110

Country

Brazil

Facility Name

Local Institution - 0056

City

Fortaleza

State/Province

Ceara

ZIP/Postal Code

60336550

Country

Brazil

Facility Name

Local Institution - 0053

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90020-090

Country

Brazil

Facility Name

Local Institution - 0055

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Local Institution - 0052

City

Barretos

State/Province

Sao Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Local Institution - 0051

City

Rio De Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

Local Institution - 0133

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Local Institution

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Local Institution - 0110

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 5T1

Country

Canada

Facility Name

Local Institution - 0058

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

7600448

Country

Chile

Facility Name

Local Institution - 0077

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Local Institution - 0134

City

Santiago

State/Province

Metropolitana

Country

Chile

Facility Name

Local Institution - 0012

City

Viña Del Mar

State/Province

Valparaiso

Country

Chile

Facility Name

Local Institution - 0018

City

Praha 8

ZIP/Postal Code

180 81

Country

Czechia

Facility Name

Local Institution

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Local Institution

City

Dijon Cedex

ZIP/Postal Code

21079

Country

France

Facility Name

Local Institution - 0119

City

La Roche Sur Yon Cedex 9

ZIP/Postal Code

85925

Country

France

Facility Name

Local Institution - 0113

City

Lyon Cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

Local Institution - 0112

City

Marseille Cedex 20

ZIP/Postal Code

13915

Country

France

Facility Name

Local Institution

City

Poitiers

ZIP/Postal Code

86000

Country

France

Facility Name

Local Institution - 0114

City

Rennes Cedex 9

ZIP/Postal Code

35033

Country

France

Facility Name

Local Institution

City

Toulouse

ZIP/Postal Code

31300

Country

France

Facility Name

Local Institution

City

Bad Berka

ZIP/Postal Code

99437

Country

Germany

Facility Name

Local Institution

City

Grosshansdorf

ZIP/Postal Code

22927

Country

Germany

Facility Name

Local Institution

City

Heidelberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

Local Institution - 0090

City

Koeln

ZIP/Postal Code

51109

Country

Germany

Facility Name

Local Institution

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Local Institution

City

Recklinghausen

ZIP/Postal Code

45657

Country

Germany

Facility Name

Local Institution

City

Stuttgart

ZIP/Postal Code

70376

Country

Germany

Facility Name

Local Institution

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Local Institution - 0043

City

Hong Kong

ZIP/Postal Code

Country

Hong Kong

Facility Name

Local Institution

City

Hong Kong

Country

Hong Kong

Facility Name

Local Institution - 0074

City

Budapest

ZIP/Postal Code

H-1121

Country

Hungary

Facility Name

Local Institution - 0122

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Local Institution - 0086

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Local Institution - 0087

City

Meldola (fc)

ZIP/Postal Code

47014

Country

Italy

Facility Name

Local Institution - 0085

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution - 0084

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Local Institution - 0121

City

Parma

ZIP/Postal Code

43100

Country

Italy

Facility Name

Local Institution - 0083

City

Perugia

ZIP/Postal Code

06132

Country

Italy

Facility Name

Local Institution - 0088

City

Ravenna

ZIP/Postal Code

48121

Country

Italy

Facility Name

Local Institution - 0082

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Local Institution - 0107

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06735

Country

Mexico

Facility Name

Local Institution - 0108

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Local Institution

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64060

Country

Mexico

Facility Name

Local Institution

City

Hermosillo

State/Province

Sonora

ZIP/Postal Code

83280

Country

Mexico

Facility Name

Local Institution - 0141

City

Oslo

ZIP/Postal Code

0424

Country

Norway

Facility Name

Local Institution - 0131

City

Miraflores

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution - 0050

City

Arequipa

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution - 0048

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution - 0049

City

Lima

ZIP/Postal Code

L-27

Country

Peru

Facility Name

Local Institution - 0073

City

Krakow

State/Province

Małopolskie

ZIP/Postal Code

30-002

Country

Poland

Facility Name

Local Institution - 0068

City

Gdansk

ZIP/Postal Code

80-19

Country

Poland

Facility Name

Local Institution - 0072

City

Olsztyn

ZIP/Postal Code

10-513

Country

Poland

Facility Name

Local Institution - 0067

City

Szczecin

ZIP/Postal Code

70891

Country

Poland

Facility Name

Local Institution - 0070

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Local Institution - 0099

City

Bucuresti

ZIP/Postal Code

010976

Country

Romania

Facility Name

Local Institution - 0123

City

Cluj-Napoca

ZIP/Postal Code

400352

Country

Romania

Facility Name

Local Institution - 0063

City

Craiova

ZIP/Postal Code

200385

Country

Romania

Facility Name

Local Institution - 0061

City

Iasi

ZIP/Postal Code

700106

Country

Romania

Facility Name

Local Institution - 0062

City

Timisoara

ZIP/Postal Code

300167

Country

Romania

Facility Name

Local Institution - 0078

City

Moscow

ZIP/Postal Code

115 478

Country

Russian Federation

Facility Name

Local Institution - 0079

City

Moscow

ZIP/Postal Code

115 478

Country

Russian Federation

Facility Name

Local Institution - 0120

City

Moscow

ZIP/Postal Code

115 478

Country

Russian Federation

Facility Name

Local Institution - 0080

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Local Institution - 0001

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Local Institution

City

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Local Institution

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Local Institution

City

Chur

ZIP/Postal Code

7000

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

33449799

Citation

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.

Results Reference

derived

PubMed Identifier

30215677

Citation

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.

Results Reference

derived

PubMed Identifier

30103096

Citation

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.

Results Reference

derived

PubMed Identifier

29408986

Citation

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.

Results Reference

derived

PubMed Identifier

29023213

Citation

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.

Results Reference

derived

PubMed Identifier

26412456

Citation

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.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

Investigator Inquiry Form

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

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

Non-Squamous Cell Non-small Cell Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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