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Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer (CheckMate331)

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Topotecan

Amrubicin

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

Histologically or cytologically confirmed small cell lung cancer (SCLC)
Subjects with either limited or extensive disease stage at the initial diagnosis
Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

Untreated or symptomatic central nervous system (CNS) metastases
Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
Inadequate hematologic or hepatic function

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm A Nivolumab

Arm B Chemotherapy Topotecan

Arm B Chemotherapy Amrubicin

Arm Description

Nivolumab intravenous infusion as specified

Topotecan as specified

Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)

Outcomes

Primary Outcome Measures

Overall Survival (OS)

The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.

Secondary Outcome Measures

Progression Free Survival (PFS)

PFS is defined as the time from randomization to the date of the first documented tumor progression based on investigator assessment (per RECIST 1.1), or death due to any cause. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to initiation of the subsequent anti-cancer therapy. Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm.

Objective Response Rate (ORR)

ORR is defined as the percentage of randomized participants whose best overall response (BOR) from baseline is either a complete response (CR) or partial response (PR) based on investigator assessment per RECIST 1.1 criteria. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For participants who continue nivolumab beyond progression, the BOR should be determined based on tumor assessments before initial RECIST 1.1 defined progression. CR= Disappearance of all target lesions. Any pathological lymph nodes 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. Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm.

Full Information

NCT ID

NCT02481830

First Posted

June 23, 2015

Last Updated

July 19, 2023

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02481830

Brief Title

Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer

Acronym

CheckMate331

Official Title

An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

September 14, 2015 (Actual)

Primary Completion Date

August 17, 2018 (Actual)

Study Completion Date

August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.

6. Conditions and Keywords

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

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

569 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A Nivolumab

Arm Type

Experimental

Arm Description

Nivolumab intravenous infusion as specified

Arm Title

Arm B Chemotherapy Topotecan

Arm Type

Active Comparator

Arm Description

Topotecan as specified

Arm Title

Arm B Chemotherapy Amrubicin

Arm Type

Active Comparator

Arm Description

Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Intervention Type

Drug

Intervention Name(s)

Topotecan

Intervention Type

Drug

Intervention Name(s)

Amrubicin

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.

Time Frame

OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

From randomization to the date of first documented tumor progression, or death due to any cause. Tumor response assessed every 6 weeks from first dose until week 30, and every 12 weeks (Up to approximately 80 months)

Title

Objective Response Rate (ORR)

Description

Time Frame

From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 80 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed small cell lung cancer (SCLC) Subjects with either limited or extensive disease stage at the initial diagnosis Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: Untreated or symptomatic central nervous system (CNS) metastases Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody Inadequate hematologic or hepatic function

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

Local Institution - 0065

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Local Institution - 0024

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Local Institution - 0018

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Local Institution - 0056

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Local Institution - 0088

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68506

Country

United States

Facility Name

Local Institution - 0173

City

Johnson City

State/Province

New York

ZIP/Postal Code

13790

Country

United States

Facility Name

Local Institution - 0001

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Local Institution - 0090

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Local Institution - 0002

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Local Institution - 0057

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17604

Country

United States

Facility Name

Local Institution - 0053

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111-2412

Country

United States

Facility Name

Local Institution - 0089

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Local Institution - 0009

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Local Institution - 0070

City

Kennewick

State/Province

Washington

ZIP/Postal Code

99336

Country

United States

Facility Name

Local Institution - 0102

City

Waratah

State/Province

New South Wales

ZIP/Postal Code

2298

Country

Australia

Facility Name

Local Institution - 0030

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4032

Country

Australia

Facility Name

Local Institution - 0031

City

Elizabeth Vale

State/Province

South Australia

ZIP/Postal Code

5112

Country

Australia

Facility Name

Local Institution - 0103

City

Kurralta Park

State/Province

South Australia

ZIP/Postal Code

5037

Country

Australia

Facility Name

Local Institution - 0028

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Local Institution - 0027

City

Murdoch

ZIP/Postal Code

6150

Country

Australia

Facility Name

Local Institution - 0085

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Local Institution - 0084

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Local Institution - 0086

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Local Institution - 0013

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Local Institution - 0012

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Local Institution - 0011

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Local Institution - 0010

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Local Institution - 0095

City

Ijui

State/Province

RIO Grande DO SUL

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Local Institution - 0094

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Local Institution - 0093

City

Barretos

State/Province

Sao Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Local Institution - 0099

City

Sao Paulo

ZIP/Postal Code

01321-001

Country

Brazil

Facility Name

Local Institution - 0025

City

Recoleta

State/Province

Santiago De Chile

ZIP/Postal Code

Country

Chile

Facility Name

Local Institution - 0200

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100001

Country

China

Facility Name

Local Institution - 0199

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

Local Institution - 0188

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

Local Institution - 0190

City

Beijing

State/Province

Beijing

ZIP/Postal Code

101149

Country

China

Facility Name

Local Institution - 0197

City

Guanzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

Local Institution - 0189

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450008

Country

China

Facility Name

Local Institution - 0194

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

Facility Name

Local Institution - 0187

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130012

Country

China

Facility Name

Local Institution - 0186

City

Xian

State/Province

Shaanxi

ZIP/Postal Code

710038

Country

China

Facility Name

Local Institution - 0181

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Local Institution - 0185

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Local Institution - 0202

City

Urumqi

State/Province

Xinjiang

ZIP/Postal Code

830011

Country

China

Facility Name

Local Institution - 0183

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Facility Name

Local Institution - 0201

City

Beijing

ZIP/Postal Code

100071

Country

China

Facility Name

Local Institution - 0198

City

Guangzhou

ZIP/Postal Code

Country

China

Facility Name

Local Institution - 0182

City

Hangzhou

ZIP/Postal Code

310016

Country

China

Facility Name

Local Institution - 0192

City

Shanghai

ZIP/Postal Code

200030

Country

China

Facility Name

Local Institution - 0069

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Local Institution - 0067

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Local Institution - 0068

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Local Institution - 0066

City

Praha 4

ZIP/Postal Code

14059

Country

Czechia

Facility Name

Local Institution - 0106

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Local Institution - 0098

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Local Institution - 0100

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Local Institution - 0134

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Local Institution - 0116

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Local Institution - 0118

City

Paris Cedex 14

ZIP/Postal Code

75014

Country

France

Facility Name

Local Institution - 0131

City

Pringy Cedex

ZIP/Postal Code

74374

Country

France

Facility Name

Local Institution - 0132

City

Reims

ZIP/Postal Code

51100

Country

France

Facility Name

Local Institution - 0117

City

Toulon Cedex

ZIP/Postal Code

83056

Country

France

Facility Name

Local Institution - 0061

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Local Institution - 0055

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Local Institution - 0047

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Local Institution - 0071

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Local Institution - 0060

City

Gera

ZIP/Postal Code

07548

Country

Germany

Facility Name

Local Institution - 0019

City

Gerlingen

ZIP/Postal Code

70839

Country

Germany

Facility Name

Local Institution - 0021

City

Grosshansdorf

ZIP/Postal Code

22927

Country

Germany

Facility Name

Local Institution - 0058

City

Halle (saale)

ZIP/Postal Code

06120

Country

Germany

Facility Name

Local Institution - 0059

City

Hamburg

ZIP/Postal Code

21075

Country

Germany

Facility Name

Local Institution - 0020

City

Heidelberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

Local Institution - 0046

City

Immenstadt

ZIP/Postal Code

87509

Country

Germany

Facility Name

Local Institution - 0023

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Local Institution - 0022

City

Muenchen

ZIP/Postal Code

81925

Country

Germany

Facility Name

Local Institution - 0054

City

Oberhausen

ZIP/Postal Code

46145

Country

Germany

Facility Name

Local Institution - 0064

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Local Institution - 0063

City

Heraklion

State/Province

Creta

ZIP/Postal Code

71110

Country

Greece

Facility Name

Local Institution - 0062

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Local Institution - 0097

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

Local Institution - 0112

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Local Institution - 0110

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Local Institution - 0150

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Local Institution - 0139

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Local Institution - 0138

City

Kfar Saba

ZIP/Postal Code

Country

Israel

Facility Name

Local Institution - 0136

City

Ramat -Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution - 0166

City

Safed

ZIP/Postal Code

13100

Country

Israel

Facility Name

Local Institution - 0081

City

Bologna

ZIP/Postal Code

40139

Country

Italy

Facility Name

Local Institution - 0073

City

Livorno

ZIP/Postal Code

57100

Country

Italy

Facility Name

Local Institution - 0108

City

Lucca

ZIP/Postal Code

55100

Country

Italy

Facility Name

Local Institution - 0077

City

Meldola

ZIP/Postal Code

47014

Country

Italy

Facility Name

Local Institution - 0078

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution - 0080

City

Monza

ZIP/Postal Code

20052

Country

Italy

Facility Name

Local Institution - 0107

City

Rimini

ZIP/Postal Code

47923

Country

Italy

Facility Name

Local Institution - 0079

City

Roma

ZIP/Postal Code

00189

Country

Italy

Facility Name

Local Institution - 0159

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

4648681

Country

Japan

Facility Name

Local Institution - 0169

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

Local Institution - 0196

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Local Institution - 0155

City

Matsuyama

State/Province

Ehime

ZIP/Postal Code

7910280

Country

Japan

Facility Name

Local Institution - 0153

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

Local Institution - 0168

City

Akashi-shi

State/Province

Hyogo

ZIP/Postal Code

6738558

Country

Japan

Facility Name

Local Institution - 0163

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

6500047

Country

Japan

Facility Name

Local Institution - 0164

City

Natori-shi

State/Province

Miyagi

ZIP/Postal Code

9811293

Country

Japan

Facility Name

Local Institution - 0161

City

Niigata-shi

State/Province

Niigata

ZIP/Postal Code

951-8566

Country

Japan

Facility Name

Local Institution - 0171

City

Habikino-shi

State/Province

Osaka

ZIP/Postal Code

5838588

Country

Japan

Facility Name

Local Institution - 0175

City

Hirakata-shi

State/Province

Osaka

ZIP/Postal Code

5731191

Country

Japan

Facility Name

Local Institution - 0151

City

Osaka-sayama

State/Province

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Local Institution - 0165

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

5340021

Country

Japan

Facility Name

Local Institution - 0160

City

Sakai

State/Province

Osaka

ZIP/Postal Code

591-8555

Country

Japan

Facility Name

Local Institution - 0162

City

Kitaadachi-gun

State/Province

Saitama

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

Local Institution - 0176

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

1138431

Country

Japan

Facility Name

Local Institution - 0170

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

1040045

Country

Japan

Facility Name

Local Institution - 0174

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

5418567

Country

Japan

Facility Name

Local Institution - 0152

City

Wakayama-Shi

State/Province

Wakayama

ZIP/Postal Code

641-8510

Country

Japan

Facility Name

Local Institution - 0154

City

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Local Institution - 0145

City

Suwon

State/Province

Gyeonggi-do

ZIP/Postal Code

16247

Country

Korea, Republic of

Facility Name

Local Institution - 0146

City

Cheongju-si

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Local Institution - 0147

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Local Institution - 0148

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Local Institution - 0096

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

Local Institution - 0072

City

Oslo

ZIP/Postal Code

0424

Country

Norway

Facility Name

Local Institution - 0044

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Local Institution - 0041

City

Gdansk

ZIP/Postal Code

80-214

Country

Poland

Facility Name

Local Institution - 0032

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

Local Institution - 0033

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Facility Name

Local Institution - 0042

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Local Institution - 0035

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Local Institution - 0135

City

Bucharest

ZIP/Postal Code

020122

Country

Romania

Facility Name

Local Institution - 0114

City

Craiova

ZIP/Postal Code

200347

Country

Romania

Facility Name

Local Institution - 0113

City

Romania

ZIP/Postal Code

400015

Country

Romania

Facility Name

Local Institution - 0149

City

Timisoara, Timis

ZIP/Postal Code

300239

Country

Romania

Facility Name

Local Institution - 0122

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Local Institution - 0121

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

Local Institution - 0126

City

Saint-Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Local Institution - 0119

City

St. Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Local Institution - 0006

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Local Institution - 0005

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 0004

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Local Institution - 0003

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Local Institution - 0008

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Local Institution - 0007

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Local Institution - 0104

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Local Institution - 0133

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Local Institution - 0109

City

Winterthur

ZIP/Postal Code

8401

Country

Switzerland

Facility Name

Local Institution - 0156

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Local Institution - 0143

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Local Institution - 0157

City

London

State/Province

Greater London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Local Institution - 0082

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 4XB

Country

United Kingdom

Facility Name

Local Institution - 0083

City

Maidstone

State/Province

Kent

ZIP/Postal Code

ME16 9QQ

Country

United Kingdom

Facility Name

Local Institution - 0124

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Local Institution - 0123

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

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

Description

BMS Clinical Trial Information

URL

http://www.BMSStudyConnect.com

Description

BMS Clinical Trial Patient Recruiting

Learn more about this trial

Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer

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Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer (CheckMate331)

Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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

Learn more about this trial