Non Small Cell Lung Cancer Clinical Trial
— CheckMate 816Official title:
Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC
Verified date | October 2023 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.
Status | Active, not recruiting |
Enrollment | 505 |
Est. completion date | November 8, 2028 |
Est. primary completion date | September 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue - Lung function capacity capable of tolerating the proposed lung surgery - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 - Available tissue of primary lung tumor Exclusion Criteria: - Presence of locally advanced, inoperable or metastatic disease - Participants with active, known or suspected autoimmune disease - Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply |
Country | Name | City | State |
---|---|---|---|
Argentina | Local Institution - 0022 | Capital Federal | Buenos Aires |
Argentina | Local Institution - 0023 | Ciudad Autonoma De Buenos Aire | Buenos Aires |
Brazil | Fundacao Pio Xii Hosp Cancer De Barretos | Barretos | Sao Paulo |
Brazil | Local Institution - 0077 | Belo Horizonte | Minas Gerais |
Brazil | Local Institution - 0079 | Brasilia | Distrito Federal |
Brazil | Local Institution - 0076 | Ijui | RIO Grande DO SUL |
Brazil | Local Institution - 0073 | Porto Alegre | RIO Grande DO SUL |
Brazil | Local Institution - 0075 | Rio de Janeiro | |
Canada | Local Institution - 0095 | Gatineau | Quebec |
Canada | Local Institution - 0017 | Montreal | Quebec |
Canada | Local Institution - 0138 | Montreal | Quebec |
Canada | Local Institution - 0016 | Saskatoon | Saskatchewan |
Canada | Local Institution - 0052 | Trois-Rivieres | Quebec |
China | Local Institution | Beijing | Beijing |
China | Local Institution - 0156 | Beijing | Beijing |
China | Local Institution - 0161 | Beijing | Beijing |
China | Local Institution | Changchun | Jilin |
China | Local Institution - 0175 | Changsha | Hunan |
China | Local Institution - 0192 | Changsha | Hunan |
China | Local Institution - 0193 | Changsha | Hunan |
China | Local Institution - 0178 | Chengdu | Sichuan |
China | Local Institution - 0190 | Guangzhou | Guangdong |
China | Local Institution - 0182 | Hangzhou | Zhejiang |
China | Local Institution - 0183 | Hangzhou | Zhejiang |
China | Local Institution - 0189 | Hangzhou | Zhejiang |
China | Local Institution - 0166 | Nanchang | Jiangxi |
China | Local Institution - 0179 | Nanchang | Jiangxi |
China | Local Institution - 0160 | Shanghai | Shanghai |
China | Local Institution - 0165 | Shanghai | |
China | Local Institution - 0163 | Tianjin | Tianjin |
China | Local Institution - 0159 | XiAn | Shan1xi |
China | Local Institution - 0180 | Xian | Shan3xi |
France | Local Institution - 0059 | Marseille Cedex 20 | |
France | Local Institution - 0060 | Paris | |
France | Local Institution - 0112 | Paris Cedex 5 | |
France | Local Institution - 0064 | Pierre Benite | |
France | Local Institution - 0061 | Rennes Cedex 9 | |
France | Local Institution - 0113 | Strasbourg | |
France | Local Institution - 0058 | Toulouse | |
France | Local Institution - 0062 | Tours Cedex 09 | |
Greece | Local Institution - 0019 | Athens | |
Greece | Local Institution - 0122 | Thessaloniki | |
Hungary | Local Institution | Budapest | |
Hungary | Local Institution | Szekesfehervar | |
Italy | Local Institution - 0068 | Bari | |
Italy | Local Institution - 0080 | Genova | |
Italy | Local Institution - 0070 | Perugia | |
Italy | Local Institution - 0066 | Ravenna | |
Italy | Local Institution - 0067 | Roma | |
Japan | Local Institution - 0126 | Bunkyo-ku | Tokyo |
Japan | Local Institution - 0110 | Fukushima-shi | Fukushima |
Japan | Local Institution - 0109 | Hiroshima-Shi | Hiroshima |
Japan | Local Institution - 0118 | Kashiwa-shi | Chiba |
Japan | Local Institution - 0111 | Kitakyushu-shi | Fukuoka |
Japan | Local Institution - 0133 | Kobe-shi | Hyogo |
Japan | Local Institution - 0131 | Nagoya-shi | Aichi |
Japan | Local Institution - 0108 | Osaka-sayama-shi | Osaka |
Japan | Local Institution - 0127 | Osaka-shi | Osaka |
Japan | Local Institution - 0119 | Sakai-shi | Osaka |
Japan | Local Institution - 0147 | Sapporo-shi | Hokkaido |
Japan | Local Institution - 0148 | Sendai-shi | Miyagi |
Japan | Local Institution - 0120 | Shinjuku-ku | Tokyo |
Japan | Local Institution - 0132 | Sunto-gun | Shizuoka |
Japan | Local Institution - 0124 | Tokyo | |
Japan | Local Institution - 0123 | Yokohama-shi | Kanagawa |
Korea, Republic of | Local Institution - 0097 | Busan | |
Korea, Republic of | Local Institution - 0098 | Hwasun | |
Korea, Republic of | Local Institution - 0105 | Seoul | |
Romania | Local Institution - 0050 | Craiova | |
Romania | Local Institution - 0051 | Romania | |
Romania | Local Institution - 0069 | Sector 2 | |
Spain | Local Institution - 0028 | Barcelona | |
Spain | Local Institution - 0029 | Madrid | |
Spain | Local Institution - 0031 | Majadahonda - Madrid | |
Taiwan | Local Institution - 0102 | New Taipei City | |
Taiwan | Local Institution - 0107 | Taichung | |
Taiwan | Local Institution - 0099 | Taipei | |
Taiwan | Local Institution - 0100 | Taipei | |
Turkey | Local Institution - 0093 | Adana | |
Turkey | Local Institution - 0084 | Ankara | |
Turkey | Local Institution - 0115 | Istanbul | |
United States | Local Institution - 0027 | Albany | New York |
United States | Local Institution - 0035 | Austin | Texas |
United States | Local Institution - 0001 | Baltimore | Maryland |
United States | Local Institution - 0151 | Baltimore | Maryland |
United States | Texas Oncology | Bedford | Texas |
United States | St Vincent Frontier Cancer Center | Billings | Montana |
United States | Local Institution - 0006 | Boston | Massachusetts |
United States | Local Institution - 0008 | Boston | Massachusetts |
United States | Local Institution - 0135 | Burlington | Vermont |
United States | Local Institution - 0013 | Charleston | South Carolina |
United States | Local Institution - 0021 | Charleston | South Carolina |
United States | Local Institution - 0002 | Chicago | Illinois |
United States | Local Institution - 0015 | Chicago | Illinois |
United States | Christ Hospital | Cincinnati | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | Local Institution - 0025 | Denver | Colorado |
United States | Local Institution - 0012 | Detroit | Michigan |
United States | Local Institution - 0125 | Fairfax | Virginia |
United States | Southcoast Center For Cancer | Fairhaven | Massachusetts |
United States | Local Institution - 0153 | Fort Bliss | Texas |
United States | Local Institution - 0171 | Fort Wayne | Indiana |
United States | Local Institution - 0198 | Fredericksburg | Virginia |
United States | Local Institution - 0121 | Glendale | Arizona |
United States | Local Institution - 0146 | Greenville | South Carolina |
United States | Local Institution - 0009 | Hackensack | New Jersey |
United States | Local Institution - 0090 | Hattiesburg | Mississippi |
United States | Local Institution - 0140 | High Point | North Carolina |
United States | Memorial Regional Hospital | Hollywood | Florida |
United States | Local Institution - 0106 | Houston | Texas |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Local Institution - 0170 | Lexington | Kentucky |
United States | Local Institution - 0081 | Los Angeles | California |
United States | Local Institution - 0186 | Louisville | Kentucky |
United States | Southwest Cancer Center | Lubbock | Texas |
United States | Northwest Georgia Oncology Center, P.C. | Marietta | Georgia |
United States | Local Institution - 0136 | Miami | Florida |
United States | Intermountain Medical Center | Murray | Utah |
United States | Local Institution - 0005 | Nashville | Tennessee |
United States | Local Institution - 0092 | Nashville | Tennessee |
United States | University Medical Center New Orleans | New Orleans | Louisiana |
United States | Local Institution - 0011 | New York | New York |
United States | Illinois Cancer Specialists | Niles | Illinois |
United States | Cancer Institute Of Florida | Orlando | Florida |
United States | Orlando Health, Inc. | Orlando | Florida |
United States | Local Institution - 0010 | Philadelphia | Pennsylvania |
United States | Local Institution - 0018 | Pittsburgh | Pennsylvania |
United States | Local Institution - 0007 | Plainville | Connecticut |
United States | Kaiser Permanente | Portland | Oregon |
United States | Local Institution - 0139 | Portland | Oregon |
United States | Southwest Regional Cancer Clinic | Saint George | Utah |
United States | Local Institution - 0003 | Salt Lake City | Utah |
United States | Texas Cancer Center - Sherman | Sherman | Texas |
United States | Local Institution - 0143 | Tyler | Texas |
United States | Indian River Medical Center | Vero Beach | Florida |
United States | Local Institution - 0026 | Waco | Texas |
United States | Valley Hospital Luckow Pavili | Westwood | New Jersey |
United States | Genesis Health Care System | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd |
United States, Argentina, Brazil, Canada, China, France, Greece, Hungary, Italy, Japan, Korea, Republic of, Romania, Spain, Taiwan, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-Free Survival (EFS) | Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months) | |
Primary | Pathologic Complete Response (pCR) Rate | Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). | From randomization up to a median of 30 months after randomization. | |
Secondary | Major Pathologic Response (MPR) Rate | Major pathologic response (MPR) rate is defined as number of randomized participants with | From randomization up to a median of 30 months after randomization. | |
Secondary | Overall Survival (OS) | Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive. | From randomization to the date of death | |
Secondary | Time to Death or Distant Metastases (TTDM) | TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment. | From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months) |
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