Lung Cancer Clinical Trial
Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
Summary
The primary hypotheses are that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC.
Has not received prior systemic treatment for metastatic NSCLC.
Has measurable disease based on RECIST 1.1, as determined by the local site assessment.
Has a life expectancy of at least 3 months.
Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method.
Exclusion Criteria:
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Severe hypersensitivity to vibostolimab, pembrolizumab, chemotherapy components, and/or any of its excipients.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus.
Received prior systemic anticancer therapy for metastatic disease.
Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
History of allogenic tissue/solid organ transplant.
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
Is unable or unwilling to take folic acid or vitamin B12 supplementation.
Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
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There are 142 Locations for this study
Colorado Springs Colorado, 80909, United States
Fort Collins Colorado, 80528, United States
Jacksonville Florida, 32224, United States
Chicago Illinois, 60608, United States
Chicago Illinois, 60637, United States
Scarborough Maine, 04074, United States
Grand Rapids Michigan, 49503, United States
Rochester Minnesota, 55905, United States
Stony Brook New York, 11794, United States
Lancaster Pennsylvania, 17604, United States
Charleston South Carolina, 29414, United States
Charlottesville Virginia, 22903, United States
Berazategui Buenos Aires, B1884, Argentina
Mar del Plata Buenos Aires, B7600, Argentina
ABB Caba, C1199, Argentina
Buenos Aires Caba, C1431, Argentina
Rosario Santa Fe, 2000, Argentina
Rosario Santa Fe, 2002, Argentina
La Rioja , F5300, Argentina
Linz Oberosterreich, 4020, Austria
Linz Oberosterreich, 4021, Austria
Graz Steiermark, 8036, Austria
Innsbruck Tirol, 6020, Austria
Vienna Wien, 1140, Austria
Wien , 1210, Austria
Natal Rio Grande Do Norte, 59075, Brazil
Porto Alegre Rio Grande Do Sul, 91350, Brazil
Blumenau Santa Catarina, 89010, Brazil
Rio de Janeiro , 20230, Brazil
Sao Paulo , 01321, Brazil
Temuco Araucania, 48008, Chile
Temuco Araucania, 48101, Chile
Concepción Biobio, 40701, Chile
Santiago Region M. De Santiago, 69009, Chile
Santiago Region M. De Santiago, 75609, Chile
Santiago Region M. De Santiago, 84203, Chile
Viña del Mar Valparaiso, 25205, Chile
Antofagasta , 12400, Chile
Hefei Anhui, 23003, China
Beijing Beijing, 10014, China
Fuzhou Fujian, 35001, China
Xiamen City Fujian, 36100, China
Guangzhou Guangdong, 51051, China
Harbin Heilongjiang, 15000, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43003, China
Changsha Hunan, 41000, China
Changsha Hunan, 41001, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Nanchang Jiangxi, 33000, China
Nanchang Jiangxi, 33000, China
Changchun Jilin, 13200, China
Xi'an Shaanxi, 71006, China
Jinan Shandong, 25011, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20043, China
Cheng Du Sichuan, 61004, China
Chengdu Sichuan, 61004, China
Yibin Sichuan, 64400, China
Tianjin Tianjin, 30006, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Hangzhou Zhejiang, 31002, China
Hangzhou Zhejiang, 31005, China
Medellin Antioquia, 05003, Colombia
Valledupar Cesar, 20000, Colombia
Montería Cordoba, 23000, Colombia
Bogotá Distrito Capital De Bogota, 11022, Colombia
Pereira Risaralda, 66000, Colombia
Orléans Centre, 45067, France
Epagny Metz-Tessy Haute-Savoie, 74370, France
ANGERS cedex 02 Maine-et-Loire, 49055, France
Lille Nord-Pas-de-Calais, 59037, France
Lyon CEDEX 08 Rhone, 69373, France
Toulon Var, 83800, France
Avignon Vaucluse, 84000, France
Gießen Hessen, 35392, Germany
Dortmund Nordrhein-Westfalen, 44263, Germany
Lübeck Schleswig-Holstein, 23538, Germany
Gera Thuringen, 07548, Germany
Berlin , 13353, Germany
Haifa , 31096, Israel
Jerusalem , 90131, Israel
Kfar Saba , 44281, Israel
Ramat Gan , 52656, Israel
Tel Aviv , 64239, Israel
Matsuyama Ehime, 791-0, Japan
Toon Ehime, 791-0, Japan
Akashi Hyogo, 673-8, Japan
Kanazawa Ishikawa, 920-8, Japan
Yokohama Kanagawa, 241-8, Japan
Natori Miyagi, 981-1, Japan
Hirakata Osaka, 573-1, Japan
Ina-machi Saitama, 362-0, Japan
Nagaizumi Shizuoka, 411-8, Japan
Koto Tokyo, 135-8, Japan
Shinagawa Tokyo, 14286, Japan
Fukuoka , 810-8, Japan
Fukuoka , 811-1, Japan
Okayama , 700-8, Japan
Tokyo , 113-8, Japan
Hwasun Jeonranamdo, 58128, Korea, Republic of
Busan Pusan-Kwangyokshi, 49241, Korea, Republic of
Songpa-gu Seoul, 05505, Korea, Republic of
Deagu Taegu-Kwangyokshi, 41404, Korea, Republic of
Daejeon Taejon-Kwangyokshi, 35015, Korea, Republic of
Seoul , , Korea, Republic of
Saltillo Coahuila, 25279, Mexico
Ciudad de Mexico Distrito Federal, 06760, Mexico
Mexico Distrito Federal, 06700, Mexico
Guadalajara Jalisco, 44280, Mexico
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Warsaw Mazowieckie, 04-12, Poland
Warszawa Mazowieckie, 02-78, Poland
Przemysl Podkarpackie, 37-70, Poland
Prabuty Pomorskie, 82-55, Poland
Bystra Slaskie, 43-36, Poland
Konin Wielkopolskie, 62-50, Poland
Poznan Wielkopolskie, 60-69, Poland
A Coruña La Coruna, 15006, Spain
Las Palmas de Gran Canaria Las Palmas, 35001, Spain
Barcelona , 08035, Spain
Madrid , 28040, Spain
Sevilla , 41009, Spain
Zaragoza , 50009, Spain
Kaohsiung , 807, Taiwan
Taichung , 40447, Taiwan
Tainan , 704, Taiwan
Taipei , 100, Taiwan
Taoyuan , 333, Taiwan
Muang Khon Kaen, 40002, Thailand
Bangkok Krung Thep Maha Nakhon, 10700, Thailand
Lak Si Krung Thep Maha Nakhon, 10210, Thailand
Hatyai Songkhla, 90110, Thailand
Chiang Mai , 50200, Thailand
Üsküdar / Stanbul Istanbul, 34662, Turkey
Adana , 01250, Turkey
Ankara , 06230, Turkey
Ankara , 06680, Turkey
Ankara , 06800, Turkey
Edirne , 22030, Turkey
Istanbul , 34722, Turkey
Istanbul , 34766, Turkey
Leicester England, , United Kingdom
London England, SW10 , United Kingdom
London-Camden London, City Of, NW1 2, United Kingdom
London London, City Of, EC1A , United Kingdom
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