AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3CheckMate 227NCT02477826

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 study testing Nivolumab, Ipilimumab and Carboplatin in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 290 sites in 33 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 show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Nivolumab, Ipilimumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,747 participants
Where
290 sitesin 33 countries
Study dates
5 Aug 2015to 25 Oct 2024
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

  • Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
  • Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
  • Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria

Who cannot join

  • Subjects with untreated Central nervous system (CNS) metastases are excluded
  • Subjects with an active, known or suspected autoimmune disease are excluded
  • Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection
  • Other protocol defined inclusion/exclusion criteria apply

Trial locations and contacts

290 sites in 33 countries.

290 sites in 33 countries

China37 sites

  • Local Institution - 0313

    Beijing, Beijing Municipality, 100001

  • Local Institution - 0315

    Beijing, Beijing Municipality, 100021

  • Local Institution - 0316

    Beijing, Beijing Municipality, 100021

  • Local Institution - 0314

    Beijing, Beijing Municipality, 100032

  • Local Institution - 0329

    Changchun, Jilin, 130012

  • Local Institution - 0361

    Changchun, Jilin, 130021

  • Local Institution - 0362

    Changsha, Hunan, 410013

  • Local Institution - 0328

    Changsha, 0

  • Local Institution - 0376

    Chengdu, Sichuan, 610041

  • Local Institution - 0365

    Chongqing, Chongqing Municipality, 400037

  • Local Institution - 0364

    Chongqing, Chongqing Municipality, 400038

  • Local Institution - 0378

    Chongqing, Chongqing Municipality, 400042

  • Local Institution - 0322

    Guangzhou, Guangdong, 510060

  • Local Institution - 0372

    Guangzhou, Guangdong, 510095

  • Local Institution - 0319

    Guanzhou, Guangdong, 510080

  • Local Institution - 0325

    Haerbin, Heilongjiang, 150081

  • Local Institution - 0323

    Haikou, Hainan, 570311

  • Local Institution - 0343

    Hangzhou, Zhejiang, 310003

  • Local Institution - 0370

    Hangzhou, Zhejiang, 310009

  • Local Institution - 0342

    Hangzhou, Zhejiang, 310022

  • Local Institution - 0341

    Hangzhou, 310016

  • Local Institution - 0380

    Hefei, Anhui, 230001

  • Local Institution - 0345

    Kunming, 0

  • Local Institution - 0347

    Nanchang, Jiangxi, 0

  • Local Institution - 0360

    Qingdao, Shandong, 266061

  • Local Institution - 0336

    Shanghai, Shanghai Municipality, 200030

  • Local Institution - 0334

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0337

    Shanghai, 200030

  • Local Institution - 0374

    Shantou, 0

  • Local Institution - 0359

    Shenyang, Liaoning, 110000

  • Local Institution - 0373

    Tianjin, Tianjin Municipality, 300060

  • Local Institution - 0340

    Ürümqi, Xinjiang, 830011

  • Local Institution - 0375

    Wuhan, Hubei, 430024

  • Local Institution - 0371

    Xi'an, Shaanxi, 710061

  • Local Institution - 0333

    Xi'an, Shan3xi, 710038

  • Local Institution - 0324

    Zhengzhou, Henan, 0

  • Local Institution - 0379

    Zhengzhou, Henan, 450052

Other trials in China

Japan35 sites

  • Local Institution - 0252

    Akashi-shi, Hyōgo, 6738558

  • Local Institution - 0260

    Chiba, Chiba, 260-8677

  • Local Institution - 0147

    Chuo-ku, Tokyo, 1040045

  • Local Institution - 0160

    Fukuoka, Fukuoka, 8120054

  • Local Institution - 0353

    Hidaka-shi, Saitama, 3501298

  • Local Institution - 0155

    Hirakata-shi, Osaka, 5731191

  • Local Institution - 0258

    Hiroshima, Hiroshima, 7308518

  • Local Institution - 0146

    Kanazawa, Ishikawa-ken, 9208641

  • Local Institution - 0148

    Kashiwa-shi, Chiba, 2778577

  • Local Institution - 0256

    Kitaadachi-gun, Saitama, 3620806

  • Local Institution - 0156

    Kobe, Hyōgo, 6500047

  • Local Institution - 0149

    Koto-ku, Tokyo, 1358550

  • Local Institution - 0158

    Kurashiki-shi, Okayama-ken, 7100052

  • Local Institution - 0259

    Kurume-shi, Fukuoka, 8300011

  • Local Institution - 0159

    Matsuyama, Ehime, 791-0280

  • Local Institution - 0153

    Nagoya, Aichi-ken, 4600001

  • Local Institution - 0152

    Nagoya, Aichi-ken, 4648681

  • Local Institution - 0275

    Natori-shi, Miyagi, 9811293

  • Local Institution - 0164

    Niigata, Niigata, 9518566

  • Local Institution - 0165

    Okayama, 700-8558

  • Local Institution - 0154

    Osaka, Osaka, 5340021

  • Local Institution - 0251

    Osakasayama-shi, Osaka, 5890014

  • Local Institution - 0255

    Ota-shi, Gunma, 3730828

  • Local Institution - 0163

    Sapporo, Hokkaido, 0030804

  • Local Institution - 0253

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0254

    Sendai, Miyagi, 9800873

  • Local Institution - 0145

    Sendai, Miyagi, 9808574

  • Local Institution - 0278

    Shinjuku-ku, Tokyo, 1600023

  • Local Institution - 0151

    Sunto-gun, Shizuoka, 4118777

  • Local Institution - 0257

    Takatsuki-shi, Osaka, 5698686

  • Local Institution - 0162

    Tokyo, 113-8603

  • Local Institution - 0354

    Ube-shi, Yamaguchi, 7550241

  • Local Institution - 0157

    Wakayama, Wakayama, 641-8510

  • Local Institution - 0161

    Yokohama, Kanagawa, 2210855

  • Local Institution - 0150

    Yokohama, Kanagawa, 2360051

Other trials in Japan

United States25 sites

  • Local Institution - 0007

    Allentown, Pennsylvania, 18103

  • Local Institution - 0001

    Atlanta, Georgia, 30322

  • Local Institution - 0005

    Buffalo, New York, 14263

  • Local Institution - 0008

    Charleston, South Carolina, 29425

  • Local Institution - 0014

    Cleveland, Ohio, 44106

  • Local Institution - 0009

    Columbus, Ohio, 43210

  • Local Institution - 0306

    Dallas, Texas, 75390-8852

  • Local Institution - 0003

    Dallas, Texas, 75390

  • Local Institution - 0080

    Greenville, South Carolina, 29605

  • Local Institution - 0010

    Greenville, South Carolina, 29607

  • Local Institution - 0102

    Houston, Texas, 77030

  • Local Institution - 0074

    Kennewick, Washington, 99336

  • Local Institution - 0075

    Langhorne, Pennsylvania, 19047

  • Local Institution - 0004

    Lexington, Kentucky, 40503

  • Local Institution - 0013

    Marietta, Georgia, 30060

  • Southern Cancer Center, Inc.

    Mobile, Alabama, 36608

  • Local Institution - 0020

    Nashville, Tennessee, 37232

  • Local Institution - 0021

    New Haven, Connecticut, 06520

  • Local Institution - 0019

    New York, New York, 10065

  • Local Institution - 0299

    Philadelphia, Pennsylvania, 19107

  • Local Institution - 0012

    Philadelphia, Pennsylvania, 19111-2412

  • Local Institution - 0011

    Salt Lake City, Utah, 84108

  • Local Institution - 0017

    San Francisco, California, 94115

  • Local Institution - 0015

    Sayre, Pennsylvania, 18840

  • Local Institution - 0115

    St Louis, Missouri, 63110

Other trials in United States

France15 sites

  • Local Institution - 0216

    Angers, 49055

  • Local Institution - 0229

    Besançon, 0

  • Local Institution - 0222

    Bron, Rhône, 69677

  • Local Institution - 0283

    Caen, 14076

  • Local Institution - 0218

    Créteil, 94010

  • Local Institution - 0228

    Limoges, 87042

  • Local Institution - 0215

    Marseille, 13915

  • Local Institution - 0230

    Paris, 75018

  • Local Institution - 0227

    Pessac, 33604

  • Local Institution - 0223

    Rennes, 350330

  • Local Institution - 0225

    Rouen, 76000

  • Local Institution - 0217

    Saint-Herblain, 44805

  • Local Institution - 0221

    Saint-Priest-en-Jarez, 42271

  • Local Institution - 0224

    Strasbourg, 67000

  • Local Institution - 0226

    Toulon, 83056

Other trials in France

Germany14 sites

  • Local Institution - 0213

    Bad Berka, 99437

  • Local Institution - 0208

    Berlin, 13125

  • Local Institution - 0205

    Essen, 45147

  • Local Institution - 0210

    Frankfurt, 60590

  • Local Institution - 0211

    Gera, 07548

  • Local Institution - 0203

    Großhansdorf, 22927

  • Local Institution - 0209

    Halle, 06120

  • Local Institution - 0202

    Heidelberg, 69126

  • Local Institution - 0214

    Hemer, 58675

  • Local Institution - 0206

    Immenstadt im Allgäu, 87509

  • Local Institution - 0231

    Magdeburg, Saxony-Anhalt, 39120

  • Local Institution - 0204

    München, 81925

  • Local Institution - 0201

    Stuttgart, 70376

  • Local Institution - 0212

    Wiesbaden, 65199

Other trials in Germany

Italy13 sites

  • Azienda Ospedaliera Moscati

    Avellino, 83024

  • Local Institution - 0179

    Bergamo, 24127

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, 40138

  • Local Institution - 0084

    Livorno, 57124

  • Policlinico G. Martino

    Messina, 98125

  • Local Institution - 0083

    Milan, Lombardy, 20141

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Nazionale Tumori Fondazione Pascale

    Naples, 80131

  • Local Institution - 0087

    Perugia, 06132

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121

  • Ifo-Istituto Regina Elena

    Roma, 00144

  • Local Institution - 0089

    Roma, 00161

  • Local Institution - 0085

    Terni, 05100

Other trials in Italy

Mexico12 sites

  • Local Institution - 0192

    Chihuahua City, 31217

  • Local Institution - 0198

    Cuautitlán, State of Mexico, 54769

  • Local Institution - 0196

    Df, Mexico City, 06720

  • Local Institution - 0197

    Guadalajara, Jalisco, 44270

  • Local Institution - 0303

    Mérida, Yucatán, 97070

  • Local Institution - 0193

    Mexico City, Mexico City, 14080

  • Local Institution - 0277

    Monterrey, Nuevo León, 64060

  • Local Institution - 0267

    Morelia, Michoacán, 58000

  • Local Institution - 0195

    San Luis Potosí City, 78200

  • Local Institution - 0236

    San Luis Potosí City, 78213

  • Local Institution - 0194

    Toluca, 50180

  • Local Institution - 0191

    Zapopan, Jalisco, 44280

Other trials in Mexico

Argentina10 sites

  • Local Institution - 0170

    Berazategui, Buenos Aires, 1880

  • Local Institution - 0171

    Capital Federal, Buenos Aires, 1426

  • Local Institution - 0172

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1181

  • Local Institution - 0176

    Ciudad de Buenos Aires, Buenos Aires, 1025

  • Local Institution - 0268

    Córdoba, 5000

  • Local Institution - 0272

    Córdoba, 5016

  • Local Institution - 0297

    Córdoba, X50004FHP

  • Local Institution - 0296

    Mar del Plata, Buenos Aires, 7600

  • Local Institution - 0130

    San Miguel de Tucumán, Tucumán Province, 4000

  • Local Institution - 0177

    Viedma, 8500

Other trials in Argentina

Australia10 sites

  • Local Institution - 0301

    Blacktown, New South Wales, 2148

  • Local Institution - 0045

    Brisbane, Queensland, 4102

  • Local Institution - 0043

    Clayton, Victoria, 3168

  • Local Institution - 0046

    Elizabeth Vale, South Australia, 5112

  • Local Institution - 0042

    Fitzroy, Victoria, 3065

  • Local Institution - 0182

    Garran, Australian Capital Territory, 2605

  • Local Institution - 0300

    Gosford, New South Wales, 2250

  • Local Institution - 0040

    Murdoch, 6150

  • Local Institution - 0183

    North Tamworth, 2340

  • Local Institution - 0180

    Perth, Western Australia, 6150

Other trials in Australia

United Kingdom10 sites

  • Local Institution - 0265

    Birmingham, B4 6DHH

  • Local Institution - 0051

    Cambridgeshire, CB2 2QQ

  • Local Institution - 0109

    Edinburgh, EH4 2XU

  • Local Institution - 0118

    Leicester, Leicestershire, LE1 5WW

  • Local Institution - 0098

    London, Greater London, SW3 6JJ

  • Local Institution - 0097

    London, N18 1QX

  • Local Institution - 0050

    London, SE1 9RT

  • Local Institution - 0266

    Middlesbrough, Cleveland, TS4 3BW

  • Local Institution - 0099

    Southampton, Hampshire, SO16 0YD

  • Local Institution - 0119

    Surrey, SM2 5PT

Other trials in United Kingdom

Canada9 sites

  • Local Institution - 0103

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 0104

    London, Ontario, N6A 5W9

  • Local Institution - 0122

    Montreal, Quebec, H3T 1E2

  • Local Institution - 0106

    Québec, Quebec, G1J 1Z4

  • Local Institution - 0302

    Québec, Quebec, G1V 4G5

  • Local Institution - 0107

    Rimouski, Quebec, G5L 5T1

  • Local Institution - 0291

    Sherbrooke, Quebec, J1H 5N4

  • Local Institution - 0290

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Local Institution - 0292

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Brazil8 sites

  • Local Institution - 0127

    Barretos, São Paulo, 14784-400

  • Local Institution - 0124

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0123

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution - 0129

    Rio de Janeiro, 20231-050

  • Local Institution - 0125

    Salvador, Estado de Bahia, 40170-110

  • Local Institution - 0144

    São Paulo, 01321-001

  • Local Institution - 0126

    São Paulo, 01509-010

  • Local Institution - 0128

    São Paulo, 05403-010

Other trials in Brazil

Poland7 sites

  • Local Institution - 0060

    Bydgoszcz, 85-796

  • Local Institution - 0058

    Gdansk, 80-19

  • Local Institution - 0063

    Gdynia, 81-519

  • Local Institution - 0072

    Gliwice, 44-101

  • Local Institution - 0057

    Lodz, 93-513

  • Local Institution - 0059

    Warsaw, 02-781

  • Local Institution - 0070

    Wroclaw, 52-229

Other trials in Poland

Russia7 sites

  • Local Institution - 0137

    Chelyabinsk, 454048

  • Local Institution - 0142

    Kazan', 420029

  • Local Institution - 0022

    Moscow, 115478

  • Local Institution - 0028

    Saint Petersburg, 194291

  • Local Institution - 0049

    Saint Petersburg, 197758

  • Local Institution - 0027

    Saint Petersburg, 198255

  • Local Institution - 0143

    Ufa, 450054

Other trials in Russia

Belgium6 sites

  • Local Institution - 0034

    Charleroi, Hainaut, 6060

  • Local Institution - 0030

    Edegem, 2650

  • Local Institution - 0031

    Ghent, 9000

  • Local Institution - 0117

    Hasselt, 3500

  • Local Institution - 0121

    Roeselare, West-Vlaanderen, 8800

  • Local Institution - 0033

    Sint-Niklaas, 9100

Other trials in Belgium

Spain6 sites

  • Local Institution - 0066

    Barcelona, 08035

  • Local Institution - 0067

    Barcelona, 08916

  • Local Institution - 0065

    Madrid, 28041

  • Local Institution - 0064

    Majadahonda, Madrid, 28222

  • Local Institution - 0069

    Seville, 41013

  • Local Institution - 0068

    Valencia, 46014

Other trials in Spain

Israel5 sites

  • Local Institution - 0187

    Jerusalem, 91120

  • Local Institution - 0186

    Kfar Saba, 44281

  • Local Institution - 0185

    Petah Tikva, 49100

  • Local Institution - 0184

    Tel HaShomer, 52621

  • Local Institution - 0188

    Tsrifin, 70300

Other trials in Israel

Netherlands5 sites

  • Local Institution - 0036

    Amsterdam, 1066 CX

  • Local Institution - 0189

    Amsterdam, 1081 HV

  • Local Institution - 0169

    Breda, 4818 CK

  • Local Institution - 0037

    Rotterdam, 3014 GD

  • Local Institution - 0039

    Veldhoven, 5504 DB

Other trials in Netherlands

Peru5 sites

  • Local Institution - 0262

    Lima, 0

  • Local Institution - 0263

    Lima, 0

  • Local Institution - 0350

    Lima, 27

  • Local Institution - 0261

    Lima, 34

  • Local Institution - 0351

    Lima, Lima 41

Other trials in Peru

South Korea5 sites

  • Local Institution - 0249

    Cheongju-si, 28644

  • Local Institution - 0133

    Gangnam-gu, 06351

  • Local Institution - 0136

    Seongnam-si, Kyǒnggi-do, 436-707

  • Local Institution - 0132

    Seoul, 05505

  • Local Institution - 0135

    Seoul, 06591

Other trials in South Korea

Taiwan5 sites

  • Local Institution - 0139

    Taichung, 407

  • Local Institution - 0138

    Taipei, 100

  • Local Institution - 0140

    Taipei, 112

  • Local Institution - 0310

    Taipei, 235

  • Local Institution - 0141

    Taoyuan City, 333

Other trials in Taiwan

Colombia4 sites

  • Local Institution - 0237

    Bogotá, 0

  • Local Institution - 0238

    Bogotá, 0

  • Local Institution - 0282

    Medellín, 050034

  • Local Institution - 0273

    Pereira, Risaralda Department, 0

Other trials in Colombia

Czechia4 sites

  • Local Institution - 0112

    Hradec Králové, 500 05

  • Local Institution - 0113

    Olomouc, 779 00

  • Local Institution - 0111

    Prague, 140 59

  • Local Institution - 0232

    Příbram, 261 01

Other trials in Czechia

Greece4 sites

  • Local Institution - 0094

    Athens, Attikí, 115 27

  • Local Institution - 0095

    Heraklion, 711 10

  • Local Institution - 0190

    Neo Faliro, 18547

  • Local Institution - 0101

    Thessaloniki, 54007

Other trials in Greece

Ireland4 sites

  • Local Institution - 0053

    Beaumont, Dublin 9

  • Local Institution - 0054

    Dublin, Dublin

  • Local Institution - 0055

    Galway, 0

  • Local Institution - 0100

    Limerick, 0

Other trials in Ireland

Romania4 sites

  • Local Institution - 0167

    Craiova, 200542

  • Local Institution - 0250

    Floreşti, 407280

  • Local Institution - 0166

    Romania, 400015

  • Local Institution - 0284

    Sector 2, 022328

Other trials in Romania

South Africa4 sites

  • Local Institution - 0264

    Pretoria, Gauteng, 0002

  • Local Institution - 0234

    Sandton, Gauteng, 2196

  • Local Institution - 0233

    Saxonwold, Johannesburg, Gauteng, 2196

  • Local Institution - 0305

    Vereeniging, 1936

Other trials in South Africa

Switzerland4 sites

  • Local Institution - 0243

    Basel, 4031

  • Local Institution - 0246

    Chur, 7000

  • Local Institution - 0244

    Lausanne, 1011

  • Local Institution - 0245

    Winterthur, 8401

Other trials in Switzerland

Austria3 sites

  • Local Institution - 0241

    Graz, 8036

  • Local Institution - 0240

    Vienna, 1090

  • Local Institution - 0239

    Wels, 4600

Other trials in Austria

Chile3 sites

  • Local Institution - 0173

    Santiago, Santiago Metropolitan, 7500921

  • Local Institution - 0131

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0174

    Viña del Mar, Valparaiso, 254 0364

Other trials in Chile

Hungary3 sites

  • Local Institution - 0025

    Budapest, 1083

  • Local Institution - 0024

    Budapest, 1121

  • Local Institution - 0026

    Mátraháza, 3233

Other trials in Hungary

Finland2 sites

  • Local Institution - 0270

    Oulu, 90029

  • Local Institution - 0271

    Turku, 20520

Other trials in Finland

Lebanon2 sites

  • Local Institution - 0287

    Beirut, 00961

  • Local Institution - 0286

    Beirut, 166830

Other trials in Lebanon

About this study

Official title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

Study groups in NCT02477826
Study groupRoleWhat they receive
Arm A: NivolumabExperimentalNivolumab intravenously (IV) as specified
Receives: Drug: Nivolumab
Arm B: Nivolumab + IpilimumabExperimentalNivolumab + Ipilimumab IV as specified
Receives: Drug: Nivolumab; Drug: Ipilimumab
Arm C: Nivolumab + Platinum doublet chemotherapyExperimentalNivolumab + Platinum doublet chemotherapy (IV) dose as specified
Receives: Drug: Nivolumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Paclitaxel
Arm D: Platinum doublet chemotherapyExperimentalChemotherapy administered on specified days of IV chemotherapy
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Paclitaxel

What is being measured

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

  1. Progression-Free Survival Per BICR

    Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

    Measured: From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)

  2. Overall Survival

    OS for all randomized participants is the time between randomization date and the date of death from any cause.

    Measured: From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks)

Secondary outcomes (2)

  1. Objective Response Rate (ORR) Per BICR

    Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)

  2. Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale

    The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.

    Measured: Week 12

Timeline

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

  1. First posted23 Jun 2015 (estimated)
  2. Study start5 Aug 2015
  3. Primary completion25 Oct 2024
  4. Study completion25 Oct 2024

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
2,747 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02477826
Sponsor's protocol ID
CA209-227
Other IDs
2014-003630-23, 2014
Acronym
CheckMate 227
Status last verified
Oct 2025
First submitted
18 Jun 2015
Last updated
30 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Nishio M, Hayashi H, Goto Y, Ikeda S, Yokoyama T, Tanaka H, Tambo Y, Hotta K, Fukuhara T, Daga H, Masubuchi K, Aoyama T, Tschaika M, Hu N, Mizutani H. Nivolumab plus ipilimumab-based treatment in Japanese patients with metastatic non-small cell lung cancer and tumor PD-L1 < 1%: a pooled analysis. Int J Clin Oncol. 2026 Aug 11. doi: 10.1007/s10147-026-03116-w. Online ahead of print.

    PubMed 42579028

  • Peters S, Paz-Ares LG, Reck M, Carbone DP, Brahmer JR, Borghaei H, Lu S, O'Byrne KJ, John T, Ciuleanu TE, Schenker M, Bernabe Caro R, Nishio M, Cobo M, Lee JS, Zurawski B, Pluzanski A, Aoyama T, Tschaika M, Devas V, Grootendorst DJ, Ramalingam SS. Long-Term Survival Outcomes With First-Line Nivolumab Plus Ipilimumab-Based Treatment in Patients With Metastatic NSCLC and Tumor Programmed Death-Ligand 1 Lower Than 1%: A Pooled Analysis. J Thorac Oncol. 2025 Jan;20(1):94-108. doi: 10.1016/j.jtho.2024.09.1439. Epub 2024 Oct 4.

    PubMed 39369790

  • Mason M, Lapuente-Santana O, Halkola AS, Wang W, Mall R, Xiao X, Kaufman J, Fu J, Pfeil J, Banerjee J, Chung V, Chang H, Chasalow SD, Lin HY, Chai R, Yu T, Finotello F, Mirtti T, Mayranpaa MI, Bao J, Verschuren EW, Ahmed EI, Ceccarelli M, Miller LD, Monaco G, Hendrickx WRL, Sherif S, Yang L, Tang M, Gu SS, Zhang W, Zhang Y, Zeng Z, Das Sahu A, Liu Y, Yang W, Bedognetti D, Tang J, Eduati F, Laajala TD, Geese WJ, Guinney J, Szustakowski JD, Vincent BG, Carbone DP. A community challenge to predict clinical outcomes after immune checkpoint blockade in non-small cell lung cancer. J Transl Med. 2024 Feb 21;22(1):190. doi: 10.1186/s12967-023-04705-3.

    PubMed 38383458

  • Brahmer JR, Lee JS, Ciuleanu TE, Bernabe Caro R, Nishio M, Urban L, Audigier-Valette C, Lupinacci L, Sangha R, Pluzanski A, Burgers J, Mahave M, Ahmed S, Schoenfeld AJ, Paz-Ares LG, Reck M, Borghaei H, O'Byrne KJ, Gupta RG, Bushong J, Li L, Blum SI, Eccles LJ, Ramalingam SS. Five-Year Survival Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Metastatic Non-Small-Cell Lung Cancer in CheckMate 227. J Clin Oncol. 2023 Feb 20;41(6):1200-1212. doi: 10.1200/JCO.22.01503. Epub 2022 Oct 12.

    PubMed 36223558

  • Reck M, Ciuleanu TE, Lee JS, Schenker M, Audigier-Valette C, Zurawski B, Linardou H, Otterson GA, Salman P, Nishio M, de la Mora Jimenez E, Lesniewski-Kmak K, Albert I, Ahmed S, Syrigos K, Penrod JR, Yuan Y, Blum SI, Nathan FE, Sun X, Moreno-Koehler A, Taylor F, O'Byrne KJ. First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1. J Thorac Oncol. 2021 Apr;16(4):665-676. doi: 10.1016/j.jtho.2020.12.019. Epub 2021 Jan 21.

    PubMed 33485960

  • Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora Jimenez E, Sakai H, Albert I, Vergnenegre A, Peters S, Syrigos K, Barlesi F, Reck M, Borghaei H, Brahmer JR, O'Byrne KJ, Geese WJ, Bhagavatheeswaran P, Rabindran SK, Kasinathan RS, Nathan FE, Ramalingam SS. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019 Nov 21;381(21):2020-2031. doi: 10.1056/NEJMoa1910231. Epub 2019 Sep 28.

    PubMed 31562796

  • Reck M, Schenker M, Lee KH, Provencio M, Nishio M, Lesniewski-Kmak K, Sangha R, Ahmed S, Raimbourg J, Feeney K, Corre R, Franke FA, Richardet E, Penrod JR, Yuan Y, Nathan FE, Bhagavatheeswaran P, DeRosa M, Taylor F, Lawrance R, Brahmer J. Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial. Eur J Cancer. 2019 Jul;116:137-147. doi: 10.1016/j.ejca.2019.05.008. Epub 2019 Jun 11.

    PubMed 31195357

  • Hellmann MD, Ciuleanu TE, Pluzanski A, Lee JS, Otterson GA, Audigier-Valette C, Minenza E, Linardou H, Burgers S, Salman P, Borghaei H, Ramalingam SS, Brahmer J, Reck M, O'Byrne KJ, Geese WJ, Green G, Chang H, Szustakowski J, Bhagavatheeswaran P, Healey D, Fu Y, Nathan F, Paz-Ares L. Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden. N Engl J Med. 2018 May 31;378(22):2093-2104. doi: 10.1056/NEJMoa1801946. Epub 2018 Apr 16.

    PubMed 29658845

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Ipilimumab and Carboplatin in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 290 sites in 33 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 4 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 30 Oct 2025. 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 China, Japan, United States, France, Germany and 28 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 30 Oct 2025). 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?

Progression-Free Survival Per BICR (time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)). The study lists 2 primary outcomes in all. 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 NCT02477826, which also lists 8 linked publications.

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 30 Oct 2025.

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