Lung Cancer - Non Small Cell SquamousPhase 3NCT01285609

Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

A Phase 3 study testing Ipilimumab, Paclitaxel and Carboplatin in people with Lung Cancer - Non Small Cell Squamous, run by Bristol-Myers Squibb at 290 sites in 36 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 Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer - Non Small Cell Squamous
What is being tested?: Ipilimumab, Paclitaxel and Carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,289 participants
Where: 290 sitesin 36 countries
Study dates: 16 Jan 2011to 22 Aug 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

Non small cell lung cancer (NSCLC) - squamous cell
Stage IV or recurrent NSCLC
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Who cannot join

Brain Metastases
Autoimmune diseases

Trial locations and contacts

290 sites in 36 countries.

Country

City, postcode or hospital

290 sites in 36 countries

United States33 sites

Texas Oncology, PA - South Austin Cancer Center
Austin, Texas, 78745
Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
Lynn Cancer Institute Center For Hematology-Oncology
Boca Raton, Florida, 33486
Gabrail Cancer Center Research
Canton, Ohio, 44718
Associated in Oncology and Hematology
Chattanooga, Tennessee, 37421
University Of Illinois At Chicago Medical Center
Chicago, Illinois, 60612
Wjb Dorn Va Medical Center
Columbia, South Carolina, 29209
Durham Va Medical Center (111g)
Durham, North Carolina, 27705
Cancer Center Of The Carolinas
Greenville, South Carolina, 29615
Kentucky Cancer Clinic
Hazard, Kentucky, 41701
Carolina Biooncology Institute
Huntersville, North Carolina, 28078
St. Francis Hospital & Health Centers
Indianapolis, Indiana, 46237
Integrated Community Oncology Network
Jacksonville, Florida, 32256
University Of Kansas Cancer Center
Kansas City, Missouri, 64131
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
Thompson Oncology Group
Knoxville, Tennessee, 37916
Clinical Research Alliance, Inc.
Lake Success, New York, 11042
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
Novant Health Oncology Specialists
Lexington, North Carolina, 27295
Norton Cancer Institute
Louisville, Kentucky, 40207
Wisconsin Institutes for Medical Research
Madison, Wisconsin, 53705
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353
Floyd Memorial Cancer Center Of Indiana
New Albany, Indiana, 47150
Kaiser Permanente Northwest Region
Portland, Oregon, 97227
Quincy Medical Group
Quincy, Illinois, 62301
Sharp Memorial Hospital
San Diego, California, 92123
Guthrie Medical Group, P.C.
Sayre, Pennsylvania, 18840
Presence Medical Group Hematology Oncology
Skokie, Illinois, 60076
Southern Illinois University School Of Medicine
Springfield, Illinois, 62794-9678
Washington University School Of Medicine
St Louis, Missouri, 63110
Oklahoma Oncology And Hematology, Pc Dba
Tulsa, Oklahoma, 74146
Va Connecticut Healthcare System
West Haven, Connecticut, 06516
St Joseph Mercy Hospital
Ypsilanti, Michigan, 48197

Other trials in United States

Japan24 sites

Local Institution
Akashi, Hyogo, 6738558
Local Institution
Chuo-ku, Tokyo, 104-0045
Local Institution
Fukuoka, 8128582
Local Institution
Hirakata-shi, Osaka, 5731191
Local Institution
Kanazawa, Ishikawa-ken, 9208641
Local Institution
Kashiwa, Chiba, 277-8577
Local Institution
Kurashiki-shi, Okayama-ken, 7010192
Local Institution
Kurashiki-shi, Okayama-ken, 710-8602
Local Institution
Matsuyama, Ehime, 791-0280
Local Institution
Nagoya, Aichi-ken, 4600001
Local Institution
Nagoya, Aichi-ken, 4648681
Local Institution
Natori-shi, Miyagi, 9811293
Local Institution
Osaka, Osaka, 5340021
Local Institution
Sapporo Hokkaido, 003-080
Local Institution
Sapporo, Hokkaido, 0608648
Local Institution
Sayama, 5898511
Local Institution
Sendai, Miyagi, 9808574
Local Institution
Sendai, Miyagi, 980-0873
Local Institution
Sunto-gun, Shizuoka, 411-8777
Local Institution
Takatsuki, 569-8686
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
Guangzhou, Guangdong, 510060
Local Institution
Guanzhou, Guangdong, 510080
Local Institution
Hangzhou, Zhejiang, 310016
Local Institution
Nanjing, Jiangsu, 210002
Local Institution
Nanjing, Jiangsu, 210009
Local Institution
Santiago, 7630370
Local Institution
Shanghai, 200030
Local Institution
Shanghai, 200433
Local Institution
Shantou, Guangdong, 515041
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

Germany19 sites

Local Institution
Bad Berka, 99437
Local Institution
Bochum, 44791
Local Institution
Darmstadt, 64283
Local Institution
Dresden, 01307
Local Institution
Frankfurt am Main, 60590
Local Institution
Gauting, 82131
Local Institution
Grosshandsdorf, 22927
Local Institution
Hamburg, D-21075
Local Institution
Heidelberg, 69126
Local Institution
Kassel, 34125
Local Institution
Lübeck, 23538
Local Institution
Mainz, 55131
Local Institution
München, 81925
Local Institution
Neumünster, 24534
Local Institution
Nuremberg, 90419
Local Institution
Regensburg, 93049
Local Institution
Tübingen, 72076
Local Institution
Ulm, 89081
Local Institution
Villingen-Schwenningen, 78052

Other trials in Germany

South Korea16 sites

Local Institution
Busan, 602-739
Local Institution
Cheonju-si, North Chungcheong, 361-771
Local Institution
Daegu, 700-712
Local Institution
Goyang-si, Gyeonggi-do, 410-769
Local Institution
Gyeonggi-do, 463-802
Local Institution
Seoul, Kangnam-gu, 135-710
Local Institution
Seoul, Seodaemungu, 120-752
Local Institution
Seoul, 110-744
Local Institution
Seoul, 134-791
Local Institution
Seoul, 135-720
Local Institution
Seoul, 136-705
Local Institution
Seoul, 137-701
Local Institution
Seoul, 138-736
Local Institution
Seoul, 156-755
Local Institution
Suwon, Gyeonggi-do, 442-723
Local Institution
Suwon, 443-721

Other trials in South Korea

Brazil11 sites

Local Institution
Barretos, São Paulo, 14784
Local Institution
Belo Horizonte, Minas Gerais, 30150-270
Local Institution
Curitiba, Paraná, 81520-060
Local Institution
Fortaleza, Ceará, 60160-230
Local Institution
Passo Fundo, Rio Grande do Sul, 99010260
Local Institution
Porto Alegre, 90430
Local Institution
Ribeirão Preto, 14015
Local Institution
Rio de Janeiro, 20231-050
Local Institution
São José dos Campos, São Paulo, 12245
Local Institution
São Paulo, 01224-010
Local Institution
São Paulo, 04039-901

Other trials in Brazil

Hungary11 sites

Local Institution
Budapest, 1121
Local Institution
Budapest, 1125
Local Institution
Deszk, 6772
Local Institution
Farkasgyepű, 8582
Local Institution
Gyula, 5703
Local Institution
Mátraháza, 3233
Local Institution
Nyíregyháza, 4400
Local Institution
Pécs, 7602
Local Institution
Sopron, 9400
Local Institution
Székesfehérvár, 8000
Local Institution
Szolnok, 5000

Other trials in Hungary

Italy11 sites

Local Institution
Benevento, 82100
Local Institution
Bologna, 40138
Local Institution
Lido di Camaiore, 55041
Local Institution
Lucca, 55100
Local Institution
Monza, 20052
Local Institution
Padova, 35128
Local Institution
Perugia, 06156
Local Institution
Siena, 53100
Local Institution
Sondrio, 23100
Local Institution
Terni, 05100
Local Institution
Treviglio, 24047

Other trials in Italy

Israel10 sites

Local Institution
Beersheba, 84101
Local Institution
Haifa, 31096
Local Institution
Jerusalem, 91120
Local Institution
Nahariya, 22100
Local Institution
Petah Tikva, 49100
Local Institution
Rehovot, 76100
Local Institution
Tel Aviv, 64239
Local Institution
Tel Aviv, 69710
Local Institution
Tel HaShomer, 52621
Local Institution
Tsrifin, 70300

Other trials in Israel

Poland10 sites

Local Institution
Elblag, 82-300
Local Institution
Gdansk, 80-952
Local Institution
Gdansk- Zaspa, 80-462
Local Institution
Grudziądz, 86-300
Local Institution
Olsztyn, 10-357
Local Institution
Otwock, 05-400
Local Institution
Poznan, 60 569
Local Institution
Szczecin, 70-891
Local Institution
Torun, 87-100
Local Institution
Warsaw, 02-781

Other trials in Poland

Spain10 sites

Local Institution
Ávila, 05004
Local Institution
Barakaldo, Vizcaya, 48903
Local Institution
Benidorm-alicante, 03501
Local Institution
Castellon, 12002
Local Institution
Madrid, 28033
Local Institution
Madrid, 28041
Local Institution
Manresa, 08243
Local Institution
Ourense, 32005
Local Institution
Valencia, 46014
Local Institution
Valencia, 46015

Other trials in Spain

Russia9 sites

Local Institution
Chelyabinsk, 454087
Local Institution
Kazan', 420029
Local Institution
Moscow, 115478
Local Institution
Moscow, 125009
Local Institution
Pyatigorsk, 357502
Local Institution
Saint Petersburg, 197022
Local Institution
Saint Petersburg, 197758
Local Institution
St-Peterburg, 198255
Local Institution
Tula, 300053

Other trials in Russia

Taiwan8 sites

Local Institution
Changhua, 500
Local Institution
Chiayi City, 61363
Local Institution
Kaohsiung County, 83301
Local Institution
Taichung, 404
Local Institution
Taichung, 407.5
Local Institution
Taipei, 100
Local Institution
Taipei, 112
Local Institution
Taipei

Other trials in Taiwan

Argentina7 sites

Local Institution
Córdoba, X5006HBF
Local Institution
Córdoba, X5006IKK
Local Institution
Mendoza, M5500AYB
Local Institution
Quilmes, Buenos Aires, B1878DVB
Local Institution
Rosario, Santa Fe Province, S2000DSV
Local Institution
San Miguel de Tucumán, Tucumán Province, 4000
Local Institution
Santa Fe, S3000FFU

Other trials in Argentina

Czechia7 sites

Local Institution
Ostrava, Poruba, 70852
Local Institution
Prague, 12808
Local Institution
Prague, 150 06
Local Institution
Prague, 180 81
Local Institution
Pribram V-Zdabor, 26195
Local Institution
Ústí nad Labem, 401 13
Local Institution
Znojmo, 669 02

Other trials in Czechia

France7 sites

Local Institution
Caen, 14076
Local Institution
Marseille, 13915
Local Institution
Paris, 75014
Local Institution
Poitiers, 86000
Local Institution
Rennes, 35033
Local Institution
Toulouse, 31059
Local Institution
Vandœuvre-lès-Nancy, 54511

Other trials in France

Portugal6 sites

Local Institution
Lisbon, 1099023
Local Institution
Lisbon, 1769-001
Local Institution
Porto, 4200-072
Local Institution
Santa Maria da Feira, 4520211
Local Institution
São Martinho do Bispo, Coimbra District, 3041801
Local Institution
Vila Nova de Gaia, 4434-502

Other trials in Portugal

Romania6 sites

Local Institution
Bucharest, 010976
Local Institution
Bucharest, 030171
Local Institution
Cluj-Napoca, 400058
Local Institution
Sibiu, 550245
Local Institution
Suceava, 720237
Local Institution
Timișoara, 300239

Other trials in Romania

Thailand6 sites

Local Institution
Bangkok, Tungpayathai, 10400
Local Institution
Bangkok, 10330
Local Institution
Bangkok, 10400
Local Institution
Bangkok, 10700
Local Institution
Chiang Mai, 50200
Local Institution
Songkhla, 90110

Other trials in Thailand

Australia5 sites

Local Institution
Bedford Park, South Australia, 5042
Local Institution
Box Hill, Victoria, 3128
Local Institution
Frankston, Victoria, 3199
Local Institution
Heidelberg, Victoria, 3084
Local Institution
Wodonga, Victoria, 3690

Other trials in Australia

Denmark5 sites

Local Institution
Aalborg, 9000
Local Institution
Herlev, 2730
Local Institution
Hillerød, 3400
Local Institution
Næstved, 4700
Local Institution
Odense, 5000

Other trials in Denmark

United Kingdom5 sites

Local Institution
Dundee, Angus/forfarshire, DD1 9SY
Local Institution
Nottingham, NG51PB
Local Institution
Sheffield, s10 2SJ
Local Institution
Southampton, Hampshire, SO16 6YD
Local Institution
Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Belgium4 sites

Local Institution
Aalst, 9300
Local Institution
Liège, 4000
Local Institution
Sint-Niklaas, 9100
Local Institution
Yvoir, 5530

Other trials in Belgium

Canada4 sites

Local Institution
Montreal, Quebec, H2W 1S6
Local Institution
Montreal, Quebec, H3T 1E2
Local Institution
Montreal, Quebec, H4J 1C5
Local Institution
Oshawa, L1G 2B9

Other trials in Canada

Ireland4 sites

Local Institution
Dublin, 24
Local Institution
Dublin, 4
Local Institution
Dublin, 8
Local Institution
Galway

Other trials in Ireland

Netherlands4 sites

Local Institution
's-Hertogenbosch, 5223 GZ
Local Institution
Breda, 4818 CK
Local Institution
Harderwijk, 3844 DG
Local Institution
Nieuwegein, 3435 CM

Other trials in Netherlands

Peru4 sites

Local Institution
Arequipa
Local Institution
Cercado
Local Institution
Lima, LIMA 11
Local Institution
Trujillo, La Libertad

Other trials in Peru

South Africa4 sites

Local Institution
Cape Town, 7925
Local Institution
Durban, 4067
Local Institution
Panorama,cape Town, Western Cape, 7500
Local Institution
Vereeniging, Gauteng, 1939

Other trials in South Africa

Sweden4 sites

Local Institution
Gothenburg, 413 45
Local Institution
Lund, 221 85
Local Institution
Stockholm, 17176
Local Institution
Umeå, SE-901 85

Other trials in Sweden

Austria3 sites

Local Institution
Graz, 8036
Local Institution
Linz, 4020
Local Institution
Salzburg, 5020

Other trials in Austria

Chile3 sites

Local Institution
Santiago, Santiago Metropolitan, 7520378
Local Institution
Santiago, Santiago Metropolitan, 8380455
Local Institution
Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Hong Kong3 sites

Local Institution
Hong Kong, 8525
Local Institution
Hong Kong
Local Institution
New Territories, 8520

Other trials in Hong Kong

Mexico3 sites

Local Institution
Mexico City, Mexico City, 06760
Local Institution
Monterrey, Nuevo León, 64060
Local Institution
Zapopan, Jalisco, 45170

Other trials in Mexico

Colombia2 sites

Local Institution
Montería, Departamento de Córdoba
Local Institution
Pereira, Risaralda Department

Other trials in Colombia

Switzerland2 sites

Local Institution
Basel, 4031
Local Institution
Winterthur, 8401

Other trials in Switzerland

Singapore1 site

Local Institution
Singapore, 308433

Other trials in Singapore

About this study

Official title: Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)

Read the detailed description

The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).

Conditions: Lung Cancer - Non Small Cell Squamous
Being tested: Ipilimumab, Placebo, Paclitaxel, Carboplatin

What participants receive

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

IpilimumabDrug
Also called BMS-734016
PlaceboDrug
PaclitaxelDrug
Also called Taxol®
CarboplatinDrug
Also called Paraplatin®

Study groups in NCT01285609
Study group	Role	What they receive
Ipilimumab + Paclitaxel and Carboplatin	Experimental	Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses Receives: Drug: Ipilimumab; Drug: Paclitaxel; Drug: Carboplatin
Placebo + Paclitaxel and Carboplatin	Placebo comparator	Placebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses Receives: Drug: Placebo; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Measured: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)

Secondary outcomes (2)

Overall Survival (OS) in All Randomized Participants at Primary Endpoint
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Measured: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Measured: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)

Timeline

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

16 Jan 201122 Aug 2017

First posted28 Jan 2011 (estimated)
Study start16 Jan 2011
Primary completion9 Jun 2015
Study completion22 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung Cancer - Non Small Cell SquamousStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 1,289 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01285609
Sponsor's protocol ID: CA184-104
Other IDs: 2009-017396-19, 2009
Status last verified: Jun 2020
First submitted: 24 Jan 2011
Last updated: 18 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer - Non Small Cell Squamous trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT01285609
Acronym / sponsor ID: CA184-104
Conditions: Lung Cancer - Non Small Cell Squamous
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,289 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 16 Jan 2011 (actual)
Primary completion: 9 Jun 2015 (actual)
Study completion: 22 Aug 2017 (actual)
First posted: 28 Jan 2011 (estimated)
Results: Posted 23 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ipilimumab + Paclitaxel and Carboplatin	Experimental	Drug: Ipilimumab, Drug: Paclitaxel, Drug: CarboplatinIpilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Placebo + Paclitaxel and Carboplatin	Placebo comparator	Drug: Placebo, Drug: Paclitaxel, Drug: CarboplatinPlacebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Non small cell lung cancer (NSCLC) - squamous cell
Stage IV or recurrent NSCLC
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key exclusion criteria (2 listed)

Brain Metastases
Autoimmune diseases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IpilimumabAlso: BMS-734016	Drug	Ipilimumab + Paclitaxel and Carboplatin
Placebo	Drug	Placebo + Paclitaxel and Carboplatin
PaclitaxelAlso: Taxol®	Drug	Ipilimumab + Paclitaxel and Carboplatin, Placebo + Paclitaxel and Carboplatin
CarboplatinAlso: Paraplatin®	Drug	Ipilimumab + Paclitaxel and Carboplatin, Placebo + Paclitaxel and Carboplatin

Primary outcome

Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Time frame: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.

2 secondary outcomes

Overall Survival (OS) in All Randomized Participants at Primary Endpoint
Time frame: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Time frame: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)

Results and safety

Results posted to the registry on 23 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ipilimumab With Paclitaxel/Carboplatin	479	388
Placebo With Paclitaxel/Carboplatin	477	361

Primary outcome: Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint

Time frame: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start). Median (95% Confidence Interval). Unit: months

Measure	Ipilimumab With Paclitaxel/Carboplatin n = 388	Placebo With Paclitaxel/Carboplatin n = 361
Value	13.37 (11.76 to 14.78)	12.42 (11.60 to 13.63)

Ipilimumab With Paclitaxel/Carboplatin vs Placebo With Paclitaxel/Carboplatin: Hazard Ratio (HR): 0.907 (95% CI 0.767 to 1.072), p = 0.2517, Log Rank

Population analysed: All treated participants who received at least one dose of blinded therapy

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day of first dose to 90 days post final dose, up to August 2017 (approximately 72 months post study start). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 MG/KG Ipilimumab + Paclitaxel/ Carbop	300 of 475 (63.2%)	437 of 475 (92%)	359 of 475
Placebo + Paclitaxel/ Carboplatin	235 of 473 (49.7%)	428 of 473 (90.5%)	371 of 473

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

290 sites in 36 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ipilimumab, Paclitaxel and Carboplatin in people with Lung Cancer - Non Small Cell Squamous, run by Bristol-Myers Squibb at 290 sites in 36 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 3 inclusion and 2 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 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 290 sites in United States, Japan, China, Germany, South Korea and 31 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 23 Jun 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 at Primary Endpoint (time frame: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)). 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 NCT01285609.

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 18 Jun 2020.