AzTrials
AzTrials

Lung CancerPhase 3CheckMate331NCT02481830

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

A Phase 3 study testing Nivolumab, Topotecan and Amrubicin in people with Lung Cancer, run by Bristol-Myers Squibb at 151 sites in 25 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 this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Nivolumab, Topotecan and Amrubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
569 participants
Where
151 sitesin 25 countries
Study dates
14 Sep 2015to 30 Aug 2022
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

151 sites in 25 countries.

151 sites in 25 countries

Japan20 sites

  • Local Institution - 0168

    Akashi-shi, Hyōgo, 6738558

  • Local Institution - 0176

    Bunkyo-ku, Tokyo, 1138431

  • Local Institution - 0170

    Chuo-ku, Tokyo, 1040045

  • Local Institution - 0174

    Chuo-ku, Tokyo, 5418567

  • Local Institution - 0153

    Fukuoka, Fukuoka, 811-1395

  • Local Institution - 0171

    Habikino-shi, Osaka, 5838588

  • Local Institution - 0175

    Hirakata-shi, Osaka, 5731191

  • Local Institution - 0196

    Kashiwa, Chiba, 277-8577

  • Local Institution - 0162

    Kitaadachi-gun, Saitama, 362-0806

  • Local Institution - 0163

    Kobe, Hyōgo, 6500047

  • Local Institution - 0155

    Matsuyama, Ehime, 7910280

  • Local Institution - 0169

    Nagoya, Aichi-ken, 460-0001

  • Local Institution - 0159

    Nagoya, Aichi-ken, 4648681

  • Local Institution - 0164

    Natori-shi, Miyagi, 9811293

  • Local Institution - 0161

    Niigata, Niigata, 951-8566

  • Local Institution - 0165

    Osaka, Osaka, 5340021

  • Local Institution - 0151

    Ōsaka-sayama, Osaka, 589-8511

  • Local Institution - 0160

    Sakai, Osaka, 591-8555

  • Local Institution - 0154

    Tokyo, 135-8550

  • Local Institution - 0152

    Wakayama, Wakayama, 641-8510

Other trials in Japan

China17 sites

  • Local Institution - 0200

    Beijing, Beijing Municipality, 100001

  • Local Institution - 0199

    Beijing, Beijing Municipality, 100021

  • Local Institution - 0188

    Beijing, Beijing Municipality, 100032

  • Local Institution - 0190

    Beijing, Beijing Municipality, 101149

  • Local Institution - 0201

    Beijing, 100071

  • Local Institution - 0187

    Changchun, Jilin, 130012

  • Local Institution - 0198

    Guangzhou, 0

  • Local Institution - 0197

    Guanzhou, Guangdong, 510080

  • Local Institution - 0183

    Hangzhou, Zhejiang, 310022

  • Local Institution - 0182

    Hangzhou, 310016

  • Local Institution - 0194

    Nanjing, Jiangsu, 210000

  • Local Institution - 0181

    Shanghai, Shanghai Municipality, 200025

  • Local Institution - 0185

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0192

    Shanghai, 200030

  • Local Institution - 0202

    Ürümqi, Xinjiang, 830011

  • Local Institution - 0186

    Xi'an, Shaanxi, 710038

  • Local Institution - 0189

    Zhengzhou, Henan, 450008

Other trials in China

Germany15 sites

  • Local Institution - 0061

    Bamberg, 96049

  • Local Institution - 0055

    Berlin, 13125

  • Local Institution - 0023

    Cologne, 50937

  • Local Institution - 0047

    Essen, 45122

  • Local Institution - 0071

    Frankfurt am Main, 60590

  • Local Institution - 0060

    Gera, 07548

  • Local Institution - 0019

    Gerlingen, 70839

  • Local Institution - 0021

    Großhansdorf, 22927

  • Local Institution - 0058

    Halle, 06120

  • Local Institution - 0059

    Hamburg, 21075

  • Local Institution - 0020

    Heidelberg, 69126

  • Local Institution - 0046

    Immenstadt im Allgäu, 87509

  • Local Institution - 0022

    München, 81925

  • Local Institution - 0054

    Oberhausen, 46145

  • Local Institution - 0064

    Regensburg, 93053

Other trials in Germany

United States14 sites

  • Local Institution - 0018

    Atlanta, Georgia, 30322

  • Local Institution - 0002

    Bethlehem, Pennsylvania, 18015

  • Local Institution - 0090

    Cleveland, Ohio, 44106

  • Local Institution - 0001

    Durham, North Carolina, 27710

  • Local Institution - 0173

    Johnson City, New York, 13790

  • Local Institution - 0070

    Kennewick, Washington, 99336

  • Local Institution - 0057

    Lancaster, Pennsylvania, 17604

  • Local Institution - 0088

    Lincoln, Nebraska, 68506

  • Local Institution - 0065

    Little Rock, Arkansas, 72205

  • Local Institution - 0089

    Nashville, Tennessee, 37203

  • Local Institution - 0009

    Nashville, Tennessee, 37232

  • Local Institution - 0024

    New Haven, Connecticut, 06520

  • Local Institution - 0053

    Philadelphia, Pennsylvania, 19111-2412

  • Local Institution - 0056

    St Louis, Missouri, 63110

Other trials in United States

Italy8 sites

  • Local Institution - 0081

    Bologna, 40139

  • Local Institution - 0073

    Livorno, 57100

  • Local Institution - 0108

    Lucca, 55100

  • Local Institution - 0077

    Meldola, 47014

  • Local Institution - 0078

    Milan, 20133

  • Local Institution - 0080

    Monza, 20052

  • Local Institution - 0107

    Rimini, 47923

  • Local Institution - 0079

    Roma, 00189

Other trials in Italy

Australia6 sites

  • Local Institution - 0030

    Brisbane, Queensland, 4032

  • Local Institution - 0031

    Elizabeth Vale, South Australia, 5112

  • Local Institution - 0103

    Kurralta Park, South Australia, 5037

  • Local Institution - 0027

    Murdoch, 6150

  • Local Institution - 0028

    Perth, Western Australia, 6150

  • Local Institution - 0102

    Waratah, New South Wales, 2298

Other trials in Australia

France6 sites

  • Local Institution - 0134

    Brest, 29200

  • Local Institution - 0116

    Lille, 59037

  • Local Institution - 0118

    Paris, 75014

  • Local Institution - 0131

    Pringy, 74374

  • Local Institution - 0132

    Reims, 51100

  • Local Institution - 0117

    Toulon, 83056

Other trials in France

Poland6 sites

  • Local Institution - 0044

    Elblag, 82-300

  • Local Institution - 0041

    Gdansk, 80-214

  • Local Institution - 0032

    Krakow, 31-202

  • Local Institution - 0033

    Lodz, 93-513

  • Local Institution - 0042

    Poznan, 60-569

  • Local Institution - 0035

    Warsaw, 02-781

Other trials in Poland

Spain6 sites

  • Local Institution - 0006

    Barcelona, 08025

  • Local Institution - 0005

    Barcelona, 08035

  • Local Institution - 0004

    Madrid, 28034

  • Local Institution - 0003

    Madrid, 28050

  • Local Institution - 0008

    Seville, 41009

  • Local Institution - 0007

    Valencia, 46026

Other trials in Spain

United Kingdom5 sites

  • Local Institution - 0157

    London, Greater London, SW3 6JJ

  • Local Institution - 0083

    Maidstone, Kent, ME16 9QQ

  • Local Institution - 0082

    Manchester, Greater Manchester, M20 4XB

  • Local Institution - 0123

    Southampton, SO16 6YD

  • Local Institution - 0124

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Belgium4 sites

  • Local Institution - 0013

    Brussels, 1200

  • Local Institution - 0012

    Edegem, 2650

  • Local Institution - 0011

    Leuven, 3000

  • Local Institution - 0010

    Yvoir, 5530

Other trials in Belgium

Brazil4 sites

  • Local Institution - 0093

    Barretos, São Paulo, 14784-400

  • Local Institution - 0095

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0094

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution - 0099

    São Paulo, 01321-001

Other trials in Brazil

Czechia4 sites

  • Local Institution - 0069

    Brno, 625 00

  • Local Institution - 0067

    Brno, 656 53

  • Local Institution - 0068

    Olomouc, 779 00

  • Local Institution - 0066

    Prague, 14059

Other trials in Czechia

Israel4 sites

  • Local Institution - 0139

    Beersheba, 84101

  • Local Institution - 0138

    Kfar Saba, 0

  • Local Institution - 0136

    Ramat Gan, 52621

  • Local Institution - 0166

    Safed, 13100

Other trials in Israel

Romania4 sites

  • Local Institution - 0135

    Bucharest, 020122

  • Local Institution - 0114

    Craiova, 200347

  • Local Institution - 0113

    Romania, 400015

  • Local Institution - 0149

    Timisoara, Timis, 300239

Other trials in Romania

Russia4 sites

  • Local Institution - 0122

    Moscow, 115478

  • Local Institution - 0121

    Ryazan, 390011

  • Local Institution - 0119

    Saint Petersburg, 194291

  • Local Institution - 0126

    Saint Petersburg, 197758

Other trials in Russia

South Korea4 sites

  • Local Institution - 0146

    Cheongju-si, 28644

  • Local Institution - 0147

    Seoul, 02841

  • Local Institution - 0148

    Seoul, 05505

  • Local Institution - 0145

    Suwon, Gyeonggi-do, 16247

Other trials in South Korea

Switzerland4 sites

  • Local Institution - 0104

    Basel, 4031

  • Local Institution - 0133

    Lausanne, 1011

  • Local Institution - 0109

    Winterthur, 8401

  • Local Institution - 0156

    Zurich, 8091

Other trials in Switzerland

Austria3 sites

  • Local Institution - 0085

    Graz, 8036

  • Local Institution - 0086

    Vienna, 1090

  • Local Institution - 0084

    Wels, 4600

Other trials in Austria

Denmark3 sites

  • Local Institution - 0106

    Copenhagen, 2100

  • Local Institution - 0098

    Herlev, 2730

  • Local Institution - 0100

    Odense, 5000

Other trials in Denmark

Greece3 sites

  • Local Institution - 0062

    Athens, 11527

  • Local Institution - 0063

    Heraklion, Crete, 71110

  • Local Institution - 0097

    Thessaloniki, 56429

Other trials in Greece

Hungary3 sites

  • Local Institution - 0112

    Budapest, 1083

  • Local Institution - 0110

    Budapest, 1121

  • Local Institution - 0150

    Budapest, 1121

Other trials in Hungary

Norway2 sites

  • Local Institution - 0096

    Bergen, 5021

  • Local Institution - 0072

    Oslo, 0424

Other trials in Norway

Chile1 site

  • Local Institution - 0025

    Recoleta, Santiago de Chile, 0

Other trials in Chile

Taiwan1 site

  • Local Institution - 0143

    Taichung, 404

Other trials in Taiwan

About this study

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)

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

Conditions
Lung Cancer
Being tested
Nivolumab, Topotecan, Amrubicin
Medical subject headings
Lung Neoplasms

What participants receive

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

Study groups in NCT02481830
Study groupRoleWhat they receive
Arm A NivolumabExperimentalNivolumab intravenous infusion as specified
Receives: Drug: Nivolumab
Arm B Chemotherapy TopotecanActive comparatorTopotecan as specified
Receives: Drug: Topotecan
Arm B Chemotherapy AmrubicinActive comparatorAmrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)
Receives: Drug: Amrubicin

What is being measured

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

  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.

    Measured: 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)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

Timeline

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

  1. First posted25 Jun 2015 (estimated)
  2. Study start14 Sep 2015
  3. Primary completion17 Aug 2018
  4. Study completion30 Aug 2022

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
569 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02481830
Sponsor's protocol ID
CA209-331
Other IDs
2015-001097-18, 2015
Acronym
CheckMate331
Status last verified
Jul 2023
First submitted
23 Jun 2015
Last updated
27 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Topotecan and Amrubicin in people with Lung Cancer, run by Bristol-Myers Squibb at 151 sites in 25 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 4 inclusion and 3 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in Japan, China, Germany, United States, Italy and 20 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 9 Jan 2020). 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 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). 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 NCT02481830.

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 27 Jul 2023.

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

Free account

Log in to keep searching

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

Create a free accountLog in