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

NCT02481830 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-3312015-001097-18
• Study Type: interventional
• Target: 569
• Locations: 24 countries
• Sites: 145

Brief Summary

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

• Progression Free Survival (PFS)

  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)

• Objective Response Rate (ORR)

  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)

Study Arms (3)

Arm A Nivolumab

EXPERIMENTAL

Nivolumab intravenous infusion as specified

Drug: Nivolumab

Arm B Chemotherapy Topotecan

ACTIVE COMPARATOR

Topotecan as specified

Drug: Topotecan

Arm B Chemotherapy Amrubicin

ACTIVE COMPARATOR

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

Drug: Amrubicin

Interventions

Nivolumab DRUG

Arm A Nivolumab

Topotecan DRUG

Arm B Chemotherapy Topotecan

Amrubicin DRUG

Arm B Chemotherapy Amrubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (151)

Local Institution - 0065

Little Rock, Arkansas, 72205, United States

Location

Local Institution - 0024

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0018

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0056

St Louis, Missouri, 63110, United States

Location

Local Institution - 0088

Lincoln, Nebraska, 68506, United States

Location

Local Institution - 0173

Johnson City, New York, 13790, United States

Location

Local Institution - 0001

Durham, North Carolina, 27710, United States

Location

Local Institution - 0090

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0002

Bethlehem, Pennsylvania, 18015, United States

Location

Local Institution - 0057

Lancaster, Pennsylvania, 17604, United States

Location

Local Institution - 0053

Philadelphia, Pennsylvania, 19111-2412, United States

Location

Local Institution - 0089

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0009

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0070

Kennewick, Washington, 99336, United States

Location

Local Institution - 0102

Waratah, New South Wales, 2298, Australia

Location

Local Institution - 0030

Brisbane, Queensland, 4032, Australia

Location

Local Institution - 0031

Elizabeth Vale, South Australia, 5112, Australia

Location

Local Institution - 0103

Kurralta Park, South Australia, 5037, Australia

Location

Local Institution - 0028

Perth, Western Australia, 6150, Australia

Location

Local Institution - 0027

Murdoch, 6150, Australia

Location

Local Institution - 0085

Graz, 8036, Austria

Location

Local Institution - 0086

Vienna, 1090, Austria

Location

Local Institution - 0084

Wels, 4600, Austria

Location

Local Institution - 0013

Brussels, 1200, Belgium

Location

Local Institution - 0012

Edegem, 2650, Belgium

Location

Local Institution - 0011

Leuven, 3000, Belgium

Location

Local Institution - 0010

Yvoir, 5530, Belgium

Location

Local Institution - 0095

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution - 0094

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Local Institution - 0093

Barretos, São Paulo, 14784-400, Brazil

Location

Local Institution - 0099

São Paulo, 01321-001, Brazil

Location

Local Institution - 0025

Recoleta, Santiago de Chile, 0, Chile

Location

Local Institution - 0200

Beijing, Beijing Municipality, 100001, China

Location

Local Institution - 0199

Beijing, Beijing Municipality, 100021, China

Location

Local Institution - 0188

Beijing, Beijing Municipality, 100032, China

Location

Local Institution - 0190

Beijing, Beijing Municipality, 101149, China

Location

Local Institution - 0197

Guanzhou, Guangdong, 510080, China

Location

Local Institution - 0189

Zhengzhou, Henan, 450008, China

Location

Local Institution - 0194

Nanjing, Jiangsu, 210000, China

Location

Local Institution - 0187

Changchun, Jilin, 130012, China

Location

Local Institution - 0186

Xi'an, Shaanxi, 710038, China

Location

Local Institution - 0181

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution - 0185

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0202

Ürümqi, Xinjiang, 830011, China

Location

Local Institution - 0183

Hangzhou, Zhejiang, 310022, China

Location

Local Institution - 0201

Beijing, 100071, China

Location

Local Institution - 0198

Guangzhou, 0, China

Location

Local Institution - 0182

Hangzhou, 310016, China

Location

Local Institution - 0192

Shanghai, 200030, China

Location

Local Institution - 0069

Brno, 625 00, Czechia

Location

Local Institution - 0067

Brno, 656 53, Czechia

Location

Local Institution - 0068

Olomouc, 779 00, Czechia

Location

Local Institution - 0066

Prague, 14059, Czechia

Location

Local Institution - 0106

Copenhagen, 2100, Denmark

Location

Local Institution - 0098

Herlev, 2730, Denmark

Location

Local Institution - 0100

Odense, 5000, Denmark

Location

Local Institution - 0134

Brest, 29200, France

Location

Local Institution - 0116

Lille, 59037, France

Location

Local Institution - 0118

Paris, 75014, France

Location

Local Institution - 0131

Pringy, 74374, France

Location

Local Institution - 0132

Reims, 51100, France

Location

Local Institution - 0117

Toulon, 83056, France

Location

Local Institution - 0061

Bamberg, 96049, Germany

Location

Local Institution - 0055

Berlin, 13125, Germany

Location

Local Institution - 0023

Cologne, 50937, Germany

Location

Local Institution - 0047

Essen, 45122, Germany

Location

Local Institution - 0071

Frankfurt am Main, 60590, Germany

Location

Local Institution - 0060

Gera, 07548, Germany

Location

Local Institution - 0019

Gerlingen, 70839, Germany

Location

Local Institution - 0021

Großhansdorf, 22927, Germany

Location

Local Institution - 0058

Halle, 06120, Germany

Location

Local Institution - 0059

Hamburg, 21075, Germany

Location

Local Institution - 0020

Heidelberg, 69126, Germany

Location

Local Institution - 0046

Immenstadt im Allgäu, 87509, Germany

Location

Local Institution - 0022

München, 81925, Germany

Location

Local Institution - 0054

Oberhausen, 46145, Germany

Location

Local Institution - 0064

Regensburg, 93053, Germany

Location

Local Institution - 0063

Heraklion, Crete, 71110, Greece

Location

Local Institution - 0062

Athens, 11527, Greece

Location

Local Institution - 0097

Thessaloniki, 56429, Greece

Location

Local Institution - 0112

Budapest, 1083, Hungary

Location

Local Institution - 0110

Budapest, 1121, Hungary

Location

Local Institution - 0150

Budapest, 1121, Hungary

Location

Local Institution - 0139

Beersheba, 84101, Israel

Location

Local Institution - 0138

Kfar Saba, 0, Israel

Location

Local Institution - 0136

Ramat Gan, 52621, Israel

Location

Local Institution - 0166

Safed, 13100, Israel

Location

Local Institution - 0081

Bologna, 40139, Italy

Location

Local Institution - 0073

Livorno, 57100, Italy

Location

Local Institution - 0108

Lucca, 55100, Italy

Location

Local Institution - 0077

Meldola, 47014, Italy

Location

Local Institution - 0078

Milan, 20133, Italy

Location

Local Institution - 0080

Monza, 20052, Italy

Location

Local Institution - 0107

Rimini, 47923, Italy

Location

Local Institution - 0079

Roma, 00189, Italy

Location

Local Institution - 0169

Nagoya, Aichi-ken, 460-0001, Japan

Location

Local Institution - 0159

Nagoya, Aichi-ken, 4648681, Japan

Location

Local Institution - 0196

Kashiwa, Chiba, 277-8577, Japan

Location

Local Institution - 0155

Matsuyama, Ehime, 7910280, Japan

Location

Local Institution - 0153

Fukuoka, Fukuoka, 811-1395, Japan

Location

Local Institution - 0168

Akashi-shi, Hyōgo, 6738558, Japan

Location

Local Institution - 0163

Kobe, Hyōgo, 6500047, Japan

Location

Local Institution - 0164

Natori-shi, Miyagi, 9811293, Japan

Location

Local Institution - 0161

Niigata, Niigata, 951-8566, Japan

Location

Local Institution - 0171

Habikino-shi, Osaka, 5838588, Japan

Location

Local Institution - 0175

Hirakata-shi, Osaka, 5731191, Japan

Location

Local Institution - 0165

Osaka, Osaka, 5340021, Japan

Location

Local Institution - 0151

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Local Institution - 0160

Sakai, Osaka, 591-8555, Japan

Location

Local Institution - 0162

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

Local Institution - 0176

Bunkyo-ku, Tokyo, 1138431, Japan

Location

Local Institution - 0170

Chuo-ku, Tokyo, 1040045, Japan

Location

Local Institution - 0174

Chuo-ku, Tokyo, 5418567, Japan

Location

Local Institution - 0152

Wakayama, Wakayama, 641-8510, Japan

Location

Local Institution - 0154

Tokyo, 135-8550, Japan

Location

Local Institution - 0096

Bergen, 5021, Norway

Location

Local Institution - 0072

Oslo, 0424, Norway

Location

Local Institution - 0044

Elblag, 82-300, Poland

Location

Local Institution - 0041

Gdansk, 80-214, Poland

Location

Local Institution - 0032

Krakow, 31-202, Poland

Location

Local Institution - 0033

Lodz, 93-513, Poland

Location

Local Institution - 0042

Poznan, 60-569, Poland

Location

Local Institution - 0035

Warsaw, 02-781, Poland

Location

Local Institution - 0135

Bucharest, 020122, Romania

Location

Local Institution - 0114

Craiova, 200347, Romania

Location

Local Institution - 0113

Romania, 400015, Romania

Location

Local Institution - 0149

Timisoara, Timis, 300239, Romania

Location

Local Institution - 0122

Moscow, 115478, Russia

Location

Local Institution - 0121

Ryazan, 390011, Russia

Location

Local Institution - 0119

Saint Petersburg, 194291, Russia

Location

Local Institution - 0126

Saint Petersburg, 197758, Russia

Location

Local Institution - 0145

Suwon, Gyeonggi-do, 16247, South Korea

Location

Local Institution - 0146

Cheongju-si, 28644, South Korea

Location

Local Institution - 0147

Seoul, 02841, South Korea

Location

Local Institution - 0148

Seoul, 05505, South Korea

Location

Local Institution - 0006

Barcelona, 08025, Spain

Location

Local Institution - 0005

Barcelona, 08035, Spain

Location

Local Institution - 0004

Madrid, 28034, Spain

Location

Local Institution - 0003

Madrid, 28050, Spain

Location

Local Institution - 0008

Seville, 41009, Spain

Location

Local Institution - 0007

Valencia, 46026, Spain

Location

Local Institution - 0104

Basel, 4031, Switzerland

Location

Local Institution - 0133

Lausanne, 1011, Switzerland

Location

Local Institution - 0109

Winterthur, 8401, Switzerland

Location

Local Institution - 0156

Zurich, 8091, Switzerland

Location

Local Institution - 0143

Taichung, 404, Taiwan

Location

Local Institution - 0157

London, Greater London, SW3 6JJ, United Kingdom

Location

Local Institution - 0082

Manchester, Greater Manchester, M20 4XB, United Kingdom

Location

Local Institution - 0083

Maidstone, Kent, ME16 9QQ, United Kingdom

Location

Local Institution - 0124

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Local Institution - 0123

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Nivolumab; Topotecan; amrubicin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

1(800) 332-2056

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 25, 2015
• Study Start: September 14, 2015
• Primary Completion: August 17, 2018
• Study Completion: August 30, 2022
• Last Updated: July 27, 2023
• Results First Posted: January 9, 2020

Record last verified: 2023-07

Locations

GB (5); JP (20); HU (3); RO (4); DK (3); RU (4); AU (3); CH (4); NO (2); CL (1); TW (1); DE (15); GR (3); IL (4); ES (6); CN (17); US (14); BR (4); CZ (4); BE (4); IT (8); FR (6); PL (6); KR (4)