Non-Small Cell Lung Cancer (NSCLC) Clinical Trial
— CheckMate73LOfficial title:
A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
| Verified date | January 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).
| Status | Active, not recruiting |
| Enrollment | 888 |
| Est. completion date | December 3, 2026 |
| Est. primary completion date | July 7, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status =1 - Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible. - Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease Exclusion Criteria: - Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation - Active infection requiring systemic therapy within 14 days prior to randomization - History of organ or tissue transplant that requires systemic use of immune suppressive agents - Prior thoracic radiotherapy Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0043 | Buenos Aires | Distrito Federal |
| Argentina | Local Institution - 0042 | Caba | Distrito Federal |
| Argentina | Local Institution - 0044 | Caba | Buenos Aires |
| Argentina | Local Institution - 0045 | Río Cuarto | Cordoba |
| Australia | Local Institution - 0028 | Adelaide | South Australia |
| Australia | Local Institution - 0224 | Ballarat Central | Victoria |
| Australia | Local Institution - 0031 | Darlinghurst | New South Wales |
| Australia | Local Institution - 0134 | Gosford | New South Wales |
| Australia | Local Institution - 0029 | Greenslopes | Queensland |
| Australia | Local Institution - 0033 | Kingswood | New South Wales |
| Australia | Local Institution | Melbourne | Victoria |
| Australia | Local Institution - 0052 | Melbourne | Victoria |
| Australia | Local Institution - 0030 | Murdoch | Western Australia |
| Belgium | Local Institution - 0003 | Bruxelles | |
| Belgium | Local Institution - 0001 | Gent | |
| Belgium | Local Institution - 0004 | Liege | |
| Belgium | Local Institution - 0002 | Yvoir | |
| Brazil | Local Institution - 0036 | Barretos | SAO Paulo |
| Brazil | Local Institution - 0037 | Blumenau | Santa Catarina |
| Brazil | Local Institution - 0234 | Ijui | RIO Grande DO SUL |
| Brazil | Local Institution - 0038 | Ipatinga | Minas Gerais |
| Brazil | Local Institution - 0034 | Porto Alegre | RIO Grande DO SUL |
| Brazil | Local Institution - 0035 | Rio de Janeiro | |
| Canada | Local Institution - 0237 | Chicoutimi | Quebec |
| Canada | Local Institution - 0127 | Kingston | Ontario |
| Canada | Local Institution - 0078 | Oshawa | Ontario |
| Canada | Local Institution - 0126 | Quebec | |
| Canada | Local Institution - 0070 | Rimouski | Quebec |
| Canada | Local Institution - 0092 | Trois-Rivieres | Quebec |
| Chile | Local Institution - 0041 | Santiago | Metropolitana |
| Chile | Local Institution - 0040 | Vina del Mar | Valparaiso |
| China | Local Institution - 0146 | Beijing | BEI |
| China | Local Institution - 0170 | Changchun | Jilin |
| China | Local Institution - 0183 | Changchun | Jilin |
| China | Local Institution - 0154 | Changsha | Hunan |
| China | Local Institution - 0186 | Chengdu | Sichuan |
| China | Local Institution - 0189 | Chengdu | Sichuan |
| China | Local Institution - 0149 | Chongqing | Chongqing |
| China | Local Institution - 0179 | Fuzhou | Fujian |
| China | Local Institution - 0180 | Gongzhuling | Jilin |
| China | Local Institution - 0192 | Guiyang | Guizhou |
| China | Local Institution - 0140 | Hangzhou | Zhejiang |
| China | Local Institution - 0147 | Hankou | Hubei |
| China | Local Institution - 0138 | Jinan | Shandong |
| China | Local Institution - 0184 | Linhai | Zhejiang |
| China | Local Institution - 0178 | Nanchang | Jiangxi |
| China | Local Institution - 0139 | Nanjing | Jiangsu |
| China | Local Institution - 0145 | Shanghai | Shanghai |
| China | Local Institution - 0148 | Wuhan | Hubei |
| China | Local Institution - 0150 | Wuhan | Hubei |
| China | Local Institution - 0164 | Xiamen | Fujian |
| France | Local Institution - 0086 | Bordeaux | |
| France | Local Institution - 0087 | Dijon | |
| France | Local Institution - 0081 | Lyon | |
| France | Local Institution - 0082 | Montpellier | |
| France | Local Institution - 0084 | Nantes | |
| France | Local Institution - 0091 | Paris | |
| France | Local Institution - 0227 | Paris | |
| France | Local Institution - 0090 | Paris Cedex 14 | |
| France | Local Institution - 0083 | Paris Cedex 5 | |
| France | Local Institution - 0089 | Tours Cedex 09 | |
| Germany | Local Institution - 0060 | Berlin | |
| Germany | Local Institution - 0063 | Essen | |
| Germany | Local Institution - 0076 | Grosshansdorf | |
| Germany | Local Institution - 0101 | Hamm | |
| Germany | Local Institution - 0073 | Heidelberg | |
| Germany | Local Institution - 0061 | Immenhausen | |
| Germany | Local Institution - 0062 | Kempten | |
| Germany | Local Institution - 0075 | Loewenstein | |
| Germany | Local Institution - 0109 | Mainz | |
| Germany | Local Institution - 0072 | Stuttgart | |
| Greece | Local Institution - 0135 | Athens | |
| Greece | Local Institution - 0161 | Athens | |
| Greece | Local Institution - 0136 | Larissa | |
| Greece | Local Institution - 0162 | N.Kifissia | |
| Ireland | Local Institution - 0023 | Dublin | |
| Ireland | Local Institution - 0024 | Dublin 8 | Dublin |
| Italy | Local Institution - 0068 | Brescia | |
| Italy | Aou Policlinico V. Emanuele Di Catania | Catania | |
| Italy | Azienda Ospedaliero-Universitaria Mater Domini | Catanzaro | |
| Italy | Ospedale San Luca | Lucca | |
| Italy | Istituto Europeo di Oncologia IRCCS | Milano | |
| Italy | ASST di Monza - Azienda Ospedaliera San Gerardo | Monza | |
| Italy | Azienda Ospedaliera Di Perugia | Perugia | |
| Japan | Local Institution - 0199 | Bunkyo-ku | Tokyo |
| Japan | Local Institution - 0200 | Chuo-ku | Tokyo |
| Japan | Local Institution - 0212 | Fukuoka-shi | Fukuoka |
| Japan | Local Institution - 0198 | Hidaka-shi | Saitama |
| Japan | Local Institution - 0203 | Kanazawa-shi | Ishikawa |
| Japan | Local Institution - 0174 | Kitaadachi-gun | Saitama |
| Japan | Local Institution - 0206 | Kobe | Hyogo |
| Japan | Local Institution - 0211 | Kurume-shi | Fukuoka |
| Japan | Local Institution - 0204 | Nagoya | Aichi |
| Japan | Local Institution - 0202 | Niigata-shi | Niigata |
| Japan | Local Institution - 0205 | Osaka-shi | Osaka |
| Japan | Local Institution - 0210 | Osakasayama | Osaka |
| Japan | Local Institution - 0197 | Ota | Gunma |
| Japan | Local Institution - 0195 | Sapporo-shi | Hokkaido |
| Japan | Local Institution - 0196 | Sendai-shi | Miyagi |
| Japan | Local Institution - 0232 | Ube | Yamaguchi |
| Japan | Local Institution - 0175 | Wakayama-shi | Wakayama |
| Japan | Local Institution - 0217 | Yokohama | Kanagawa |
| Japan | Local Institution - 0201 | Yokohama-Shi | Kanagawa |
| Japan | Local Institution - 0216 | Yokohama-shi | Kanagawa |
| Korea, Republic of | Local Institution - 0167 | Cheongju-si, Chungcheonbuk-do, | |
| Korea, Republic of | Local Institution - 0152 | Seoul | |
| Korea, Republic of | Local Institution - 0168 | Seoul | |
| Mexico | Local Institution - 0015 | Culiacan | Sinaloa |
| Mexico | Local Institution - 0067 | Df | Distrito Federal |
| Mexico | Local Institution - 0080 | Guadalajara | Jalisco |
| Mexico | Local Institution - 0027 | La Paz | BAJA Californa SUR |
| Mexico | Local Institution - 0014 | Monterrey | Nuevo LEON |
| Netherlands | Local Institution - 0006 | Amsterdam | |
| Netherlands | Local Institution - 0025 | Arnhem | |
| Netherlands | Local Institution - 0240 | Leiden | |
| Netherlands | Local Institution - 0005 | Maastrict | |
| Netherlands | Local Institution - 0026 | Veldhoven | |
| Poland | Local Institution - 0107 | Bydgoszcz | |
| Poland | Local Institution - 0102 | Gdansk | |
| Poland | Local Institution - 0104 | Krakow | |
| Poland | Local Institution - 0235 | Tomaszow Mazowiecki | |
| Puerto Rico | Local Institution - 0120 | Hato Rey | |
| Puerto Rico | GCM Medical Group, PSC - Hato Rey Site | San Juan | |
| Romania | Local Institution - 0018 | Bucharest | |
| Romania | Local Institution - 0222 | Bucuresti | |
| Romania | Local Institution - 0019 | Cluj-Napoca | |
| Romania | Local Institution - 0020 | Constanta | |
| Romania | Local Institution - 0017 | Craiova | |
| Romania | Local Institution - 0021 | Floresti/ Cluj | |
| Russian Federation | Local Institution | Moscow | |
| Russian Federation | Local Institution | Moscow | |
| Russian Federation | Local Institution | Moscow | |
| Russian Federation | Local Institution | St. Petersburg | |
| Singapore | Local Institution - 0171 | Singapore | |
| Spain | Local Institution - 0106 | Barcelona | |
| Spain | Local Institution - 0099 | Hospitalet de Llobregat | |
| Spain | Local Institution - 0095 | Madrid | |
| Spain | Local Institution - 0096 | Madrid | |
| Spain | Local Institution - 0098 | Pamplona | |
| Spain | Local Institution - 0105 | Santiago de Compostela | |
| Spain | Local Institution - 0097 | Sevilla | |
| Spain | Local Institution - 0100 | Zaragoza | |
| Sweden | Local Institution - 0065 | Goteborg | Vastra Gotalands Lan |
| Sweden | Local Institution - 0064 | Stockholm | |
| Switzerland | Local Institution - 0057 | Basel | |
| Switzerland | Local Institution - 0058 | Lausanne | |
| Switzerland | Local Institution - 0059 | St.Gallen | |
| Switzerland | Local Institution - 0056 | Zuerich | |
| Taiwan | Local Institution - 0208 | KaohsiungCity | |
| Taiwan | Local Institution - 0214 | New Taipei City | |
| Taiwan | Local Institution - 0209 | Tainan | |
| Taiwan | Local Institution - 0143 | Taipei | |
| Taiwan | Local Institution - 0213 | Taipei | |
| Taiwan | Local Institution - 0133 | Taipei City | |
| United Kingdom | Local Institution - 0054 | Aberdeen | |
| United Kingdom | Local Institution - 0007 | Bebington | |
| United Kingdom | Local Institution - 0009 | Hull | |
| United Kingdom | Local Institution - 0010 | Poole | Dorset |
| United Kingdom | Local Institution - 0012 | Swansea | Glamorgan |
| United States | Local Institution - 0125 | Atlanta | Georgia |
| United States | Local Institution - 0165 | Augusta | Georgia |
| United States | Local Institution - 0191 | Austin | Texas |
| United States | Local Institution - 0108 | Bethesda | Maryland |
| United States | Local Institution - 0079 | Bryan | Texas |
| United States | Local Institution - 0071 | Burlington | Vermont |
| United States | Local Institution - 0077 | Charleston | South Carolina |
| United States | Local Institution - 0053 | Cincinnati | Ohio |
| United States | Local Institution - 0131 | Cincinnati | Ohio |
| United States | Local Institution - 0188 | Cincinnati | Ohio |
| United States | Local Institution - 0047 | Cleveland | Ohio |
| United States | Local Institution - 0112 | Cleveland | Ohio |
| United States | Local Institution - 0124 | Cleveland | Ohio |
| United States | Local Institution - 0130 | Dallas | Texas |
| United States | Local Institution - 0218 | Edgewood | Kentucky |
| United States | Local Institution - 0233 | Jacksonville | Florida |
| United States | Local Institution - 0119 | La Jolla | California |
| United States | Local Institution - 0129 | Lone Tree | Colorado |
| United States | Local Institution - 0219 | Orlando | Florida |
| United States | Local Institution - 0039 | Pensacola | Florida |
| United States | Local Institution - 0166 | San Francisco | California |
| United States | Local Institution - 0207 | San Francisco | California |
| United States | Local Institution - 0116 | Traverse City | Michigan |
| United States | Local Institution - 0123 | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Greece, Ireland, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A vs Arm C | Up to 7 years | ||
| Secondary | Overall Survival (OS) for Arm A vs Arm C | Up to 7 years | ||
| Secondary | PFS by RECIST 1.1 per BICR for Arm B vs Arm C | Up to 7 years | ||
| Secondary | OS for Arm B vs Arm C | Up to 7 years | ||
| Secondary | PFS by RECIST 1.1 per BICR for Arm A vs Arm B | Up to 7 years | ||
| Secondary | OS for Arm A vs Arm B | Up to 7 years | ||
| Secondary | Objective Response Rate (ORR) by RECIST 1.1 per BICR | Up to 7 years | ||
| Secondary | Duration of Response (DoR) by RECIST 1.1 per BICR | Up to 7 years | ||
| Secondary | Time to Response (TTR) by RECIST 1.1 per BICR | Up to 7 years | ||
| Secondary | PFS by RECIST 1.1 per Investigator assessment | Up to 7 years | ||
| Secondary | ORR by RECIST 1.1 per Investigator assessment | Up to 7 years | ||
| Secondary | DoR by RECIST 1.1 per Investigator assessment | Up to 7 years | ||
| Secondary | TTR by RECIST 1.1 per Investigator assessment | Up to 7 years | ||
| Secondary | Time to Death or Distant Metastases (TTDM) by RECIST 1.1 per Investigator assessment | Up to 7 years | ||
| Secondary | Incidence of Adverse Events (AEs) | Up to 7 years | ||
| Secondary | Incidence of Serious Adverse Events (SAEs) | Up to 7 years | ||
| Secondary | Incidence of select AEs | Up to 7 years | ||
| Secondary | Proportion of participants without symptom deterioration based on NSCLC-SAQ | Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) | Up to 7 years |
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