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Small Cell Lung CarcinomaPhase 3NCT01450761

Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

A Phase 3 study testing Ipilimumab, Etoposide and Cisplatin in people with Small Cell Lung Carcinoma, run by Bristol-Myers Squibb at 225 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
Ipilimumab, Etoposide and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,351 participants
Where
225 sitesin 34 countries
Study dates
13 Dec 2011to 17 May 2017
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

  • Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
  • Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Who cannot join

  • Prior systemic therapy for lung cancer
  • Symptomatic Central Nervous System (CNS) metastases
  • History of autoimmune disease

Trial locations and contacts

225 sites in 34 countries.

225 sites in 34 countries

United States42 sites

  • Ashland Bellefonte Cancer Center

    Ashland, Kentucky, 41101

  • Sutter Medical Center

    Auburn, California, 95602

  • Medical Oncology, LLC

    Augusta, Georgia, 30901

  • University Of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Associated in Oncology and Hematology

    Chattanooga, Tennessee, 37421

  • Regional Cancer Care Associates, LLC/Cherry Hill Division

    Cherry Hill, New Jersey, 08003

  • Oncology Hematology Care, Incorporated

    Cincinnati, Ohio, 45242

  • University Hospitals

    Cleveland, Ohio, 44106

  • Florida Cancer Specialists S.

    Fort Myers, Florida, 33916

  • The Jones Clinic, PC

    Germantown, Tennessee, 38138

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • University Of Texas, M. D. Anderson Cancer Center

    Houston, Texas, 77030

  • St. Francis Medical Group Oncology And Hematology Specialist

    Indianapolis, Indiana, 46237

  • Cancer Specialists, LLC

    Jacksonville, Florida, 32256

  • St. Luke'S Cancer Institute

    Kansas City, Missouri, 64111

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

  • Lake City Cancer Care

    Lake City, Florida, 32024

  • University Of Kentucky

    Lexington, Kentucky, 40536-0093

  • Southeast Nebraska Hematology & Oncology Consultants, P.C.

    Lincoln, Nebraska, 68510

  • Joe Arrington Cancer Research And Treatment Center

    Lubbock, Texas, 79410

  • Signal Point Clinical Research Center, Llc

    Middletown, Ohio, 45042

  • Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26506

  • Montgomery Cancer Center

    Mount Sterling, Kentucky, 40353

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Henry-Joyce Cancer Center

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Nassau

    New York, New York, 10065

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Kaiser Permanente

    Portland, Oregon, 97227

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Huntsman Cancer Hospital

    Salt Lake City, Utah, 84112

  • Presence Medical Group Hematology Oncology

    Skokie, Illinois, 60077

  • SIU School Of Medicine

    Springfield, Illinois, 62794-9678

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74104

  • Cancer Center Of Kansas

    Wichita, Kansas, 67214

  • St Joseph Mercy Hospital

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan24 sites

  • Local Institution

    Akashi, Hyogo, 673-8558

  • Local Institution

    Chuo-ku, Tokyo, 104-0045

  • Local Institution

    Fukoka, 811-1395

  • Local Institution

    Fukuoka, 8128582

  • Local Institution

    Hirakata-shi, Osaka, 5731191

  • Local Institution

    Kanazawa, Ishikawa-ken, 9208641

  • Local Institution

    Kashiwa, Chiba, 2778577

  • Local Institution

    Kurashiki-shi, Okayama-ken, 7010192

  • Local Institution

    Kurashiki-shi, Okayama-ken, 710-8602

  • Local Institution

    Matsuyama, Ehime, 7910280

  • Local Institution

    Nagoya, Aichi-ken, 4600001

  • Local Institution

    Nagoya, Aichi-ken, 4648681

  • Local Institution

    Natori-shi, Miyagi, 981-1293

  • Local Institution

    Osaka, 5898511

  • Local Institution

    Oskaka, 5340021

  • Local Institution

    Sapporo, Hokkaido, 0608648

  • Local Institution

    Sapporo, Hokkaido, 0030804

  • Local Institution

    Sendai, Miyagi, 980-0873

  • Local Institution

    Sunto-gun, Shizuoka, 4118777

  • Local Institution

    Takatsuki, Osaka, 5698686

  • Local Institution

    Tokyo, 135-8550

  • Local Institution

    Ube-shi, Yamaguchi, 7550241

  • Local Institution

    Yokohama, Kanagawa, 2360051

  • Local Institution

    Yokohama, Kanagawa, 2408555

Other trials in Japan

China19 sites

  • Local Institution

    Beijing, 100032

  • Local Institution

    Beijing, 100071

  • Local Institution

    Beijing, 100142

  • Local Institution

    Beijing, 100853

  • Local Institution

    Changchun, Jilin, 130012

  • Local Institution

    Chengdu, Sichuan, 610041

  • Local Institution

    Guangzhou, Guangdong, 510060

  • Local Institution

    Guangzhou, Guangdong, 510080

  • Local Institution

    Hangzhou, Zhejiang, 310009

  • Local Institution

    Hangzhou, Zhejiang

  • Local Institution

    Harbin, Heilongjiang, 150084

  • Local Institution

    Nangjing, Jiangsu, 210002

  • Local Institution

    Shanghai, 200030

  • Local Institution

    Shanghai, 200433

  • Local Institution

    Suzhou, Jiangsu, 215006

  • Local Institution

    Ürümqi, Xinjiang, 830011

  • Local Institution

    Wuhan, Hubei, 430023

  • Local Institution

    Xi'an, Shaanxi, 710038

  • Local Institution

    Xi'an, Shaanxi, 710061

Other trials in China

Germany15 sites

  • Local Institution

    Bad Berka, 99438

  • Local Institution

    Bochum, 44791

  • Local Institution

    Dresden, 01307

  • Local Institution

    Erlangen, 91054

  • Local Institution

    Frankfurt am Main, 60590

  • Local Institution

    Gauting, 82131

  • Local Institution

    Großhansdorf, 22927

  • Local Institution

    Hamburg, 20246

  • Local Institution

    Heidelberg, 69126

  • Local Institution

    Kassel, 34125

  • Local Institution

    Mainz, 55131

  • Local Institution

    Mannheim, 68167

  • Local Institution

    München, 81925

  • Local Institution

    Oldenburg, 26121

  • Local Institution

    Ulm, 89081

Other trials in Germany

Russia9 sites

  • Local Institution

    Chelyabinsk, 454087

  • Local Institution

    Krasnodar, 350040

  • Local Institution

    Kursk, 305035

  • Local Institution

    Moscow, 115478

  • Local Institution

    Pyatigorsk, 35702

  • Local Institution

    Saint Petersburg, 194291

  • Local Institution

    Saint Petersburg, 197022

  • Local Institution

    Saint Petersburg, 197758

  • Local Institution

    Saint Petersburg, 198255

Other trials in Russia

South Korea9 sites

  • Local Institution

    Busan, 602-739

  • Local Institution

    Goyang-si, Gyeonggji-do, 410-769

  • Local Institution

    Hwasun-eup, Hwasun-gun, Jeollanam-do, 519-763

  • Local Institution

    Seoul, 120-752

  • Local Institution

    Seoul, 135-710

  • Local Institution

    Seoul, 136-705

  • Local Institution

    Seoul, 138-736

  • Local Institution

    Suwon, 442-723

  • Local Institution

    Suwon, 443-721

Other trials in South Korea

Hungary8 sites

  • Local Institution

    Budapest, 1121

  • Local Institution

    Budapest, 1125

  • Local Institution

    Budapest, H-1121

  • Local Institution

    Farkasgyepű, 8582

  • Local Institution

    Mátraháza, 3233

  • Local Institution

    Pécs, H-7623

  • Local Institution

    Sopron, 9400

  • Local Institution

    Szolnok, H-5000

Other trials in Hungary

Spain8 sites

  • Local Institution

    A Coruña, Galicia, 15006

  • Local Institution

    Barcelona, 08035

  • Local Institution

    Benidorm-alicante, 03501

  • Local Institution

    Castellon, 12002

  • Local Institution

    Lleida, 25198

  • Local Institution

    Majadahonda, 28222

  • Local Institution

    Málaga, 29010

  • Local Institution

    Valencia, 46017

Other trials in Spain

Australia7 sites

  • Local Institution

    Bedford Park, South Australia, 5042

  • Local Institution

    Chermside, Queensland, 4032

  • Local Institution

    Fitzroy, Victoria, 3065

  • Local Institution

    Kogarah, New South Wales, 2217

  • Local Institution

    Perth, Western Australia, 6009

  • Local Institution

    Wodonga, Victoria, 3690

  • Local Institution

    Wollongong, New South Wales, 2500

Other trials in Australia

Poland7 sites

  • Local Institution

    Elblag, 82-300

  • Local Institution

    Karkow, 31-202

  • Local Institution

    Lublin, 20-950

  • Local Institution

    Otwock, 05-400

  • Local Institution

    Poznan, 60-569

  • Local Institution

    Torun, 87-100

  • Local Institution

    Warsaw, 02-781

Other trials in Poland

United Kingdom6 sites

  • Local Institution

    London, N18 1QX

  • Local Institution

    London, SW3 6JJ

  • Local Institution

    Preston, PR2 9HT

  • Local Institution

    Sutton, SM2 5PT

  • Local Institution

    Truro, TR1 3LJ

  • Local Institution

    Withington, Manchester, M20 4BX

Other trials in United Kingdom

Belgium5 sites

  • Local Institution

    Brussels, 1090

  • Local Institution

    Edegem, 2650

  • Local Institution

    Leuven, 3000

  • Local Institution

    Sint-Niklaas, 9100

  • Local Institution

    Yvoir, 5530

Other trials in Belgium

Israel5 sites

  • Local Institution

    Beersheba, 84101

  • Local Institution

    Kfar Saba, 44281

  • Local Institution

    Petah Tikva, 49100

  • Local Institution

    Ramat Gan, 52621

  • Local Institution

    Tsrifin, 70300

Other trials in Israel

Argentina4 sites

  • Local Institution

    Berazategui, Buenos Aires, B1884BBF

  • Local Institution

    Buenos Aires, C1226ANZ

  • Local Institution

    Buenos Aires, C1280AEB

  • Local Institution

    Provincia de Sante Fe, S2000DSV

Other trials in Argentina

Austria4 sites

  • Local Institution

    Linz, 4020

  • Local Institution

    Salzburg, 5020

  • Local Institution

    Vienna, 1130

  • Local Institution

    Vienna, 1145

Other trials in Austria

France4 sites

  • Local Institution

    Caen, 14076

  • Local Institution

    Rennes, 35033

  • Local Institution

    Toulouse, 31059

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy4 sites

  • Local Institution

    Livorno, 57100

  • Local Institution

    Lucca, 55100

  • Local Institution

    Meldola (FC), 47014

  • Local Institution

    Siena, 53100

Other trials in Italy

Romania4 sites

  • Local Institution

    Bucharest

  • Local Institution

    Cluj-Napoca, Cluj, 400058

  • Local Institution

    Cluj-Napoca, 400015

  • Local Institution

    Craiova, Dolj, 200385

Other trials in Romania

Taiwan4 sites

  • Local Institution

    Changhua, R.O.C.

  • Local Institution

    Taichung, 40705

  • Local Institution

    Taipei, 100

  • Local Institution

    Taoyuan County, 33305

Other trials in Taiwan

Brazil3 sites

  • Local Institution

    Passo Fundo, RS, 99010-260

  • Local Institution

    Sao Paulo/SP, CEP 01246000

  • Local Institution

    SP, 12245-750

Other trials in Brazil

Chile3 sites

  • Local Institution

    Santiago, 8360160

  • Local Institution

    Santiago, 8420383

  • Local Institution

    Viña del Mar, Valparaiso, Region de Valparaiso, 2540364

Other trials in Chile

Ireland3 sites

  • Local Institution

    Dublin, 4

  • Local Institution

    Dublin, 8

  • Local Institution

    Limerick

Other trials in Ireland

Netherlands3 sites

  • Local Institution

    's-Hertogenbosch, 5223 GZ

  • Local Institution

    Breda, 4818 CK

  • Local Institution

    Eindhoven, 5623 EJ

Other trials in Netherlands

Peru3 sites

  • Local Institution

    Cercado

  • Local Institution

    Lima, 027

  • Local Institution

    Lima, Lima 41

Other trials in Peru

South Africa3 sites

  • Local Institution

    Cape Town, Western Cape, 7925

  • Local Institution

    Port Elizabeth, Eastern Cape, 6045

  • Local Institution

    Pretoria, 0002

Other trials in South Africa

Sweden3 sites

  • Local Institution

    Linköping, 58185

  • Local Institution

    Stockholm, 17176

  • Local Institution

    Uppsala, 75185

Other trials in Sweden

Switzerland3 sites

  • Local Institution

    Basel, 4031

  • Local Institution

    Winterthur, 8401

  • Local Institution

    Zurich, 8091

Other trials in Switzerland

Canada2 sites

  • Local Institution

    Montreal, Quebec, H2L 4M1

  • Local Institution

    Montreal, Quebec, H2W 1S6

Other trials in Canada

Czechia2 sites

  • Local Institution

    Ostrava - Poruba, 70852

  • Local Institution

    Prague, 180 81

Other trials in Czechia

Hong Kong2 sites

  • Local Institution

    Hong Kong

  • Local Institution

    Kowloon

Other trials in Hong Kong

Mexico2 sites

  • Local Institution

    Guadalajara, Jalisco, 44280

  • Local Institution

    San Luis Potosi, S.l.p., C.P. 78218

Other trials in Mexico

Portugal2 sites

  • Local Institution

    Coimbra, 3041853

  • Local Institution

    Lisbon, 1099-023

Other trials in Portugal

Thailand2 sites

  • Local Institution

    Chiang Mai, 50200

  • Local Institution

    Songkhla, 90110

Other trials in Thailand

Colombia1 site

  • Local Institution

    Córdoba

Other trials in Colombia

About this study

Official title: Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.

Being tested
Ipilimumab, Placebo matching Ipilimumab, Etoposide, Cisplatin, Carboplatin
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • IpilimumabBiological

    Also called Yervoy, BMS-734016

  • Placebo matching IpilimumabBiological

  • EtoposideDrug

    Also called Etopophos, Neoposid, Eposin

  • CisplatinDrug

    Also called Platinol

  • CarboplatinDrug

    Also called Paraplatin

Study groups in NCT01450761
Study groupRoleWhat they receive
Ipilimumab+Etoposide+Cisplatin/CarboplatinExperimentalIpilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Receives: Biological: Ipilimumab; Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin
Placebo matching Ipilimumab+Etoposide+Cisplatin/CarboplatinPlacebo comparatorPlacebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Receives: Biological: Placebo matching Ipilimumab; Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin

What is being measured

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

  1. Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy

    Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

    Measured: Randomization until date of death, up to March 2015, approximately 38 months

Secondary outcomes (2)

  1. Overall Survival in All Randomized Participants

    Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

    Measured: From randomization until date of death, up to March 2015, approximately 38 months

  2. Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy

    Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.

    Measured: From randomization until disease progression, up to March 2015, approximately 38 months

Timeline

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

  1. First posted12 Oct 2011 (estimated)
  2. Study start13 Dec 2011
  3. Primary completion19 Mar 2015
  4. Study completion17 May 2017

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01450761
Sponsor's protocol ID
CA184-156
Other IDs
2011-000850-48
Status last verified
Jul 2020
First submitted
10 Oct 2011
Last updated
8 Jul 2020
Data monitoring committee
Yes

Publications

  • Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601.

    PubMed 27458307

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ipilimumab, Etoposide and Cisplatin in people with Small Cell Lung Carcinoma, run by Bristol-Myers Squibb at 225 sites in 34 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 2 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 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 225 sites in United States, Japan, China, Germany, Russia and 29 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. Some participants in this study may receive a placebo. 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 18 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy (time frame: Randomization until date of death, up to March 2015, approximately 38 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 NCT01450761, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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