Non-Small Cell Lung Cancer Clinical Trial
— CheckMate 227Official 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)
| Verified date | January 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 2748 |
| Est. completion date | August 30, 2024 |
| Est. primary completion date | August 29, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0170 | Berazategui | Buenos Aires |
| Argentina | Local Institution - 0171 | Capital Federal | Buenos Aires |
| Argentina | Local Institution - 0172 | Ciudad Autonoma De Buenos Aire | Buenos Aires |
| Argentina | Local Institution - 0176 | Ciudad de Buenos Aires | Buenos Aires |
| Argentina | Local Institution - 0268 | Cordoba | |
| Argentina | Local Institution - 0297 | Cordoba | |
| Argentina | Local Institution - 0272 | Córdoba | |
| Argentina | Local Institution - 0296 | Mar Del Plata | Buenos Aires |
| Argentina | Local Institution - 0130 | San Miguel de Tucuman | Tucuman |
| Argentina | Local Institution - 0177 | Viedma | RIO Negro |
| Australia | Local Institution - 0301 | Blacktown | New South Wales |
| Australia | Local Institution - 0045 | Brisbane | Queensland |
| Australia | Local Institution - 0043 | Clayton | Victoria |
| Australia | Local Institution - 0046 | Elizabeth Vale | South Australia |
| Australia | Local Institution - 0042 | Fitzroy | Victoria |
| Australia | Local Institution - 0182 | Garran | Australian Capital Territory |
| Australia | Local Institution - 0300 | Gosford | New South Wales |
| Australia | Local Institution - 0040 | Murdoch | |
| Australia | Local Institution - 0180 | Perth | Western Australia |
| Australia | Local Institution - 0183 | Tamworth | New South Wales |
| Austria | Local Institution - 0241 | Graz | |
| Austria | Local Institution - 0240 | Vienna | |
| Austria | Local Institution - 0239 | Wels | |
| Belgium | Local Institution - 0030 | Edegem | |
| Belgium | Local Institution - 0031 | Gent | |
| Belgium | Local Institution - 0034 | Gilly | |
| Belgium | Local Institution - 0117 | Hasselt | |
| Belgium | Local Institution - 0121 | Roeselare | West-Vlaanderen |
| Belgium | Local Institution - 0033 | Sint Niklaas | |
| Brazil | Local Institution - 0127 | Barretos | Sao Paulo |
| Brazil | Local Institution - 0124 | Ijui | RIO Grande DO SUL |
| Brazil | Local Institution - 0123 | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution - 0129 | Rio De Janeiro | |
| Brazil | Local Institution - 0125 | Salvador | Bahia |
| Brazil | Local Institution - 0126 | Sao Paulo | |
| Brazil | Local Institution - 0128 | Sao Paulo | |
| Brazil | Local Institution - 0144 | Sao Paulo | |
| Canada | Local Institution - 0103 | Edmonton | Alberta |
| Canada | Local Institution - 0104 | London | Ontario |
| Canada | Local Institution - 0122 | Montreal | Quebec |
| Canada | Local Institution - 0302 | Quebec | |
| Canada | Local Institution - 0106 | Quebec City | Quebec |
| Canada | Local Institution - 0107 | Rimouski | Quebec |
| Canada | Local Institution - 0291 | Sherbrooke | Quebec |
| Canada | Local Institution - 0290 | St. John's | Newfoundland and Labrador |
| Canada | Local Institution - 0292 | Trois-Rivieres | Quebec |
| Chile | Local Institution - 0131 | Santiago | Metropolitana |
| Chile | Local Institution - 0173 | Santiago | Metropolitana |
| Chile | Local Institution - 0174 | Vina Del Mar | Valparaiso |
| China | Local Institution - 0313 | Beijing | Beijing |
| China | Local Institution - 0314 | Beijing | Beijing |
| China | Local Institution - 0315 | Beijing | Beijing |
| China | Local Institution - 0316 | Beijing | Beijing |
| China | Local Institution - 0329 | Changchun | Jilin |
| China | Local Institution - 0361 | Changchun | Jilin |
| China | Local Institution - 0328 | Changsha | |
| China | Local Institution - 0362 | Changsha | Hunan |
| China | Local Institution - 0376 | Chengdu | Sichuan |
| China | Local Institution - 0364 | Chongqing | Chongqing |
| China | Local Institution - 0365 | Chongqing | Chongqing |
| China | Local Institution - 0378 | Chongqing | Chongqing |
| China | Local Institution - 0322 | Guangzhou | Guangdong |
| China | Local Institution - 0372 | Guangzhou | Guangdong |
| China | Local Institution - 0319 | Guanzhou | Guangdong |
| China | Local Institution - 0325 | Haerbin | Heilongjiang |
| China | Local Institution - 0323 | Haikou | |
| China | Local Institution - 0341 | Hangzhou | |
| China | Local Institution - 0342 | Hangzhou | Zhejiang |
| China | Local Institution - 0343 | Hangzhou | Zhejiang |
| China | Local Institution - 0370 | Hangzhou | Zhejiang |
| China | Local Institution - 0380 | Hefei | Anhui |
| China | Local Institution - 0345 | Kunming | |
| China | Local Institution - 0347 | Nanchang | Jiangxi |
| China | Local Institution - 0360 | Qingdao | Shandong |
| China | Local Institution - 0334 | Shanghai | Shanghai |
| China | Local Institution - 0336 | Shanghai | |
| China | Local Institution - 0337 | Shanghai | |
| China | Local Institution - 0374 | Shantou | |
| China | Local Institution - 0359 | Shenyang | Liaoning |
| China | Local Institution - 0373 | Tianjin | Tianjin |
| China | Local Institution - 0340 | Urumqi | Xinjiang |
| China | Local Institution - 0375 | Wuhan | Hubei |
| China | Local Institution - 0333 | Xi'an | Shan3xi |
| China | Local Institution - 0371 | Xi'an | Shaanxi |
| China | Local Institution - 0324 | Zhengzhou | Henan |
| China | Local Institution - 0379 | Zhengzhou | Henan |
| Colombia | Local Institution - 0237 | Bogota | |
| Colombia | Local Institution - 0238 | Bogota | |
| Colombia | Local Institution - 0282 | Medellin | |
| Colombia | Local Institution - 0273 | Pereira | Risaralda |
| Czechia | Local Institution - 0112 | Hradec Kralove | |
| Czechia | Local Institution - 0113 | Olomouc | |
| Czechia | Local Institution - 0111 | Praha 4 | |
| Czechia | Local Institution - 0232 | Pribram | |
| Finland | Local Institution - 0270 | Oulu | |
| Finland | Local Institution - 0271 | Turku | |
| France | Local Institution - 0216 | ANGERS Cedex 2 | |
| France | Local Institution - 0229 | Besançon Cedex | |
| France | Local Institution - 0222 | Bron | Rhône |
| France | Local Institution - 0283 | Caen | |
| France | Local Institution - 0218 | Creteil | |
| France | Local Institution - 0228 | Limoges | |
| France | Local Institution - 0215 | Marseille Cedex 20 | |
| France | Local Institution - 0230 | Paris | |
| France | Local Institution - 0227 | Pessac | |
| France | Local Institution - 0223 | Rennes | |
| France | Local Institution - 0225 | Rouen Cedex | |
| France | Local Institution - 0221 | Saint Priest En Jarez | |
| France | Local Institution - 0217 | Saint-herblain Cedex | |
| France | Local Institution - 0224 | Strasbourg | |
| France | Local Institution - 0226 | Toulon | |
| Germany | Local Institution - 0213 | Bad Berka | |
| Germany | Local Institution - 0208 | Berlin | |
| Germany | Local Institution - 0205 | Essen | |
| Germany | Local Institution - 0210 | Frankfurt | |
| Germany | Local Institution - 0211 | Gera | |
| Germany | Local Institution - 0203 | Grosshansdorf | |
| Germany | Local Institution - 0209 | Halle | |
| Germany | Local Institution - 0202 | Heidelberg | |
| Germany | Local Institution - 0214 | Hemer | |
| Germany | Local Institution - 0206 | Immenstadt | |
| Germany | Local Institution - 0231 | Magdeburg | Sachsen-Anhalt |
| Germany | Local Institution - 0204 | Muenchen | |
| Germany | Local Institution - 0201 | Stuttgart | |
| Germany | Local Institution - 0212 | Wiesbaden | |
| Greece | Local Institution - 0094 | Athens | Attikí |
| Greece | Local Institution - 0095 | Heraklion | |
| Greece | Local Institution - 0190 | Neo Faliro | |
| Greece | Local Institution - 0101 | Thessaloniki | |
| Hungary | Local Institution - 0024 | Budapest | |
| Hungary | Local Institution - 0025 | Budapest | |
| Hungary | Local Institution - 0026 | Matrahaza | |
| Ireland | Local Institution - 0053 | Dublin | |
| Ireland | Local Institution - 0054 | Dublin 8 | Dublin |
| Ireland | Local Institution - 0055 | Galway | |
| Ireland | Local Institution - 0100 | Limerick | |
| Israel | Local Institution - 0187 | Jerusalem | |
| Israel | Local Institution - 0186 | Kfar-saba | |
| Israel | Local Institution - 0185 | Petach Tikva | |
| Israel | Local Institution - 0184 | Tel-hashomer | |
| Israel | Local Institution - 0188 | Zerifin | |
| Italy | Azienda Ospedaliera Moscati | Avellino | |
| Italy | ASST Papa Giovanni XXIII | Bergamo | |
| Italy | IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola | Bologna | |
| Italy | Local Institution - 0084 | Livorno | |
| Italy | Policlinico G. Martino | Messina | |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | |
| Italy | Istituto Europeo di Oncologia IRCCS | Milan | Lombardia |
| Italy | Istituto Nazionale Tumori Fondazione Pascale | Napoli | |
| Italy | S.C. Di Oncologia Medica Azienda Ospedaliera Di Perugia | Perugia | |
| Italy | Ospedale Santa Maria delle Croci | Ravenna | |
| Italy | Ifo-Istituto Regina Elena | Roma | |
| Italy | Local Institution - 0089 | Roma | |
| Italy | Ospedale S.Maria | Terni | |
| Japan | Local Institution - 0252 | Akashi-shi | Hyogo |
| Japan | Local Institution - 0260 | Chiba-shi | Chiba |
| Japan | Local Institution - 0147 | Chuo-ku | Tokyo |
| Japan | Local Institution - 0160 | Fukuoka-shi | Fukuoka |
| Japan | Local Institution - 0353 | Hidaka-shi | Saitama |
| Japan | Local Institution - 0155 | Hirakata-shi | Osaka |
| Japan | Local Institution - 0258 | Hiroshima-shi | Hiroshima |
| Japan | Local Institution - 0146 | Kanazawa-shi | Ishikawa |
| Japan | Local Institution - 0148 | Kashiwa-shi | Chiba |
| Japan | Local Institution - 0256 | Kitaadachi-gun | Saitama |
| Japan | Local Institution - 0156 | Kobe-shi | Hyogo |
| Japan | Local Institution - 0149 | Koto-ku | Tokyo |
| Japan | Local Institution - 0158 | Kurashiki-shi | Okayama |
| Japan | Local Institution - 0259 | Kurume-shi | Fukuoka |
| Japan | Local Institution - 0159 | Matsuyama | Ehime |
| Japan | Local Institution - 0152 | Nagoya | Aichi |
| Japan | Local Institution - 0153 | Nagoya-shi | Aichi |
| Japan | Local Institution - 0275 | Natori-shi | Miyagi |
| Japan | Local Institution - 0164 | Niigata-shi | Niigata |
| Japan | Local Institution - 0165 | Okayama | |
| Japan | Local Institution - 0154 | Osaka-shi | Osaka |
| Japan | Local Institution - 0251 | Osakasayama-shi | Osaka |
| Japan | Local Institution - 0255 | Ota-shi | Gunma |
| Japan | Local Institution - 0163 | Sapporo-shi | Hokkaido |
| Japan | Local Institution - 0253 | Sapporo-shi | Hokkaido |
| Japan | Local Institution - 0145 | Sendai-shi | Miyagi |
| Japan | Local Institution - 0254 | Sendai-shi | Miyagi |
| Japan | Local Institution - 0278 | Shinjuku-ku | Tokyo |
| Japan | Local Institution - 0151 | Sunto-gun | Shizuoka |
| Japan | Local Institution - 0257 | Takatsuki-shi | Osaka |
| Japan | Local Institution - 0162 | Tokyo | |
| Japan | Local Institution - 0354 | Ube-shi | Yamaguchi |
| Japan | Local Institution - 0157 | Wakayama-shi | Wakayama |
| Japan | Local Institution - 0150 | Yokohama-Shi | Kanagawa |
| Japan | Local Institution - 0161 | Yokohama-shi | Kanagawa |
| Korea, Republic of | Local Institution - 0249 | Cheongju-si | |
| Korea, Republic of | Local Institution - 0133 | Gangnam-gu | |
| Korea, Republic of | Local Institution - 0136 | Seongnam-si | Kyonggi-do |
| Korea, Republic of | Local Institution - 0132 | Seoul | |
| Korea, Republic of | Local Institution - 0135 | Seoul | |
| Lebanon | Local Institution - 0286 | Beirut | |
| Lebanon | Local Institution - 0287 | Beirut | |
| Mexico | Local Institution - 0192 | Chihuahua | |
| Mexico | Local Institution - 0198 | Cuautitlan | Estado DE Mexico |
| Mexico | Local Institution - 0196 | Df | Distrito Federal |
| Mexico | Local Institution - 0197 | Guadalajara | Jalisco |
| Mexico | Local Institution - 0303 | Merida | Yucatán |
| Mexico | Local Institution - 0193 | Mexico | Distrito Federal |
| Mexico | Local Institution - 0277 | Monterrey | Nuevo Leon |
| Mexico | Local Institution - 0267 | Morelia | Michoacan |
| Mexico | Local Institution - 0195 | San Luis Potosi | |
| Mexico | Local Institution - 0236 | San Luis Potosi | |
| Mexico | Local Institution - 0194 | Toluca | |
| Mexico | Local Institution - 0191 | Zapopan | Jalisco |
| Netherlands | Local Institution - 0036 | Amsterdam | |
| Netherlands | Local Institution - 0189 | Amsterdam | |
| Netherlands | Local Institution - 0169 | Breda | |
| Netherlands | Local Institution - 0037 | Rotterdam | |
| Netherlands | Local Institution - 0039 | Veldhoven | |
| Peru | Local Institution - 0261 | Lima | |
| Peru | Local Institution - 0262 | Lima | |
| Peru | Local Institution - 0263 | Lima | |
| Peru | Local Institution - 0350 | Lima | |
| Peru | Local Institution - 0351 | Lima | |
| Poland | Local Institution - 0060 | Bydgoszcz | |
| Poland | Local Institution - 0058 | Gdansk | |
| Poland | Local Institution - 0063 | Gdynia | |
| Poland | Local Institution - 0072 | Gliwice | |
| Poland | Local Institution - 0057 | Lodz | |
| Poland | Local Institution - 0059 | Warszawa | |
| Poland | Local Institution - 0070 | Wroclaw | |
| Romania | Local Institution - 0167 | Craiova | |
| Romania | Local Institution - 0250 | Floresti | |
| Romania | Local Institution - 0166 | Romania | |
| Romania | Local Institution - 0284 | Sector 2 | |
| Russian Federation | Local Institution - 0137 | Chelyabinsk | |
| Russian Federation | Local Institution - 0142 | Kazan | |
| Russian Federation | Local Institution - 0022 | Moscow | |
| Russian Federation | Local Institution - 0049 | Saint-Petersburg | |
| Russian Federation | Local Institution - 0027 | St. Petersburg | |
| Russian Federation | Local Institution - 0028 | St. Petersburg | |
| Russian Federation | Local Institution - 0143 | Ufa | |
| South Africa | Local Institution - 0264 | Pretoria | Gauteng |
| South Africa | Local Institution - 0234 | Sandton | Gauteng |
| South Africa | Local Institution - 0233 | Saxonwold, Johannesburg | Gauteng |
| South Africa | Local Institution - 0305 | Vereeniging | |
| Spain | Local Institution - 0066 | Barcelona | |
| Spain | Local Institution - 0067 | Barcelona | |
| Spain | Local Institution - 0065 | Madrid | |
| Spain | Local Institution - 0064 | Majadahonda | Madrid |
| Spain | Local Institution - 0069 | Sevilla | |
| Spain | Local Institution - 0068 | Valencia | |
| Switzerland | Local Institution - 0243 | Basel | |
| Switzerland | Local Institution - 0246 | Chur | |
| Switzerland | Local Institution - 0244 | Lausanne | |
| Switzerland | Local Institution - 0245 | Winterthur | |
| Taiwan | Local Institution - 0139 | Taichung | |
| Taiwan | Local Institution - 0138 | Taipei | |
| Taiwan | Local Institution - 0140 | Taipei | |
| Taiwan | Local Institution - 0310 | Taipei | |
| Taiwan | Local Institution - 0141 | Taoyuan city | |
| United Kingdom | Local Institution - 0265 | Birmingham | |
| United Kingdom | Local Institution - 0051 | Cambridgeshire | |
| United Kingdom | Local Institution - 0109 | Edinburgh | |
| United Kingdom | Local Institution - 0118 | Leicester | Leicestershire |
| United Kingdom | Local Institution - 0050 | London | |
| United Kingdom | Local Institution - 0097 | London | |
| United Kingdom | Local Institution - 0098 | London | Greater London |
| United Kingdom | Local Institution - 0266 | Middlesborough | Cleveland |
| United Kingdom | Local Institution - 0099 | Southampton | Hampshire |
| United Kingdom | Local Institution - 0119 | Surrey | |
| United States | Local Institution - 0007 | Allentown | Pennsylvania |
| United States | Local Institution - 0001 | Atlanta | Georgia |
| United States | Local Institution - 0005 | Buffalo | New York |
| United States | Local Institution - 0008 | Charleston | South Carolina |
| United States | University Hospitals | Cleveland | Ohio |
| United States | Local Institution - 0009 | Columbus | Ohio |
| United States | Local Institution - 0003 | Dallas | Texas |
| United States | Local Institution - 0306 | Dallas | Texas |
| United States | Local Institution - 0010 | Greenville | South Carolina |
| United States | Local Institution - 0080 | Greenville | South Carolina |
| United States | Local Institution - 0102 | Houston | Texas |
| United States | Local Institution - 0074 | Kennewick | Washington |
| United States | St. Mary Medical Center | Langhorne | Pennsylvania |
| United States | Local Institution - 0004 | Lexington | Kentucky |
| United States | Local Institution - 0013 | Marietta | Georgia |
| United States | Southern Cancer Center, Inc. | Mobile | Alabama |
| United States | Local Institution - 0020 | Nashville | Tennessee |
| United States | Local Institution - 0021 | New Haven | Connecticut |
| United States | Local Institution - 0019 | New York | New York |
| United States | Local Institution - 0012 | Philadelphia | Pennsylvania |
| United States | Local Institution - 0299 | Philadelphia | Pennsylvania |
| United States | Washington University School Of Medicine | Saint Louis | Missouri |
| United States | Local Institution - 0011 | Salt Lake City | Utah |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | Local Institution - 0015 | Sayre | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, South Africa, Spain, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival (OS) | approximately 48 months | ||
| Primary | Progression-free Survival (PFS) as determined by blinded independent central review (BICR) | approximately 40 months | ||
| Secondary | Objective response rate (ORR) | ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer | Up to 48 months | |
| Secondary | Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects | Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment | Up to 48 months |
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