Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

NCT06170788 | Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 2870-007MK-2870-0072023-503376-24-00jRCT2051240089U1111-1287-1395
• Study Type: interventional
• Target: 614
• Locations: 26 countries
• Sites: 218

Brief Summary

The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Cell Death 1 Ligand 1(PDL1, PD-L1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined as the time from randomization to death from any cause.

  Up to approximately 49 months

Secondary Outcomes (13)

• Progression free survival (PFS)

  Up to approximately 49 months

• Objective Response (OR)

  Up to approximately 49 months

• Duration of Response (DOR)

  Up to approximately 49 months

• Change from Baseline in Global Health Status/Quality of Life (QOL) [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) 29 Items and 30] Score

  Baseline and up to approximately 77 months

• Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score

  Baseline and up to approximately 77 months

Study Arms (2)

Pembrolizumab + Sacituzumab tirumotecan

EXPERIMENTAL

Participants receive sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle + 400 mg Pembrolizumab every 6 weeks (q6w) via IV infusion on Day 1 of each 6-week cycle for 18 cycles. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.

Biological: Sacituzumab tirumotecan; Biological: Pembrolizumab; Drug: Supportive care measures

Pembrolizumab

ACTIVE COMPARATOR

Participants receive 400 mg Pembrolizumab via IV infusion q6w on Day 1 of each 6-week cycle for 18 cycles

Biological: Pembrolizumab; Drug: Supportive care measures

Interventions

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475, KEYTRUDA®, SCH 900475

Pembrolizumab; Pembrolizumab + Sacituzumab tirumotecan

Supportive care measures DRUG

Participants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions

Pembrolizumab; Pembrolizumab + Sacituzumab tirumotecan

Sacituzumab tirumotecan BIOLOGICAL

IV infusion

Also known as: SKB264, MK-2870

Pembrolizumab + Sacituzumab tirumotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC
• Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
• Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
• A life expectancy of at least 3 months.
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

You may not qualify if:

• Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
• Has Grade ≥2 peripheral neuropathy.
• History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
• Received prior systemic anticancer therapy for their metastatic NSCLC.
• Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
• Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
• Received radiation therapy to the lung that is \>30 Gy within 6 months of start of study intervention.
• Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
• 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.
• Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (218)

Mayo Clinic in Arizona - Phoenix ( Site 0147)

Phoenix, Arizona, 85054, United States

RECRUITING

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)

Burbank, California, 91505, United States

RECRUITING

Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)

Grand Junction, Colorado, 81501, United States

RECRUITING

Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133)

Jacksonville, Florida, 32224, United States

RECRUITING

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106)

Marietta, Georgia, 30060, United States

COMPLETED

The University of Louisville, James Graham Brown Cancer Center ( Site 0121)

Louisville, Kentucky, 40202, United States

RECRUITING

New England Cancer Specialists ( Site 0143)

Westbrook, Maine, 04092, United States

RECRUITING

University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144)

Worcester, Massachusetts, 01655, United States

COMPLETED

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)

Minneapolis, Minnesota, 55407, United States

RECRUITING

Mayo Clinic - Rochester ( Site 0148)

Rochester, Minnesota, 55905, United States

RECRUITING

Hattiesburg Clinic Hematology/Oncology ( Site 0104)

Hattiesburg, Mississippi, 39401, United States

RECRUITING

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)

Reno, Nevada, 89502, United States

RECRUITING

University Hospitals Cleveland Medical Center ( Site 0119)

Cleveland, Ohio, 44106, United States

COMPLETED

Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117)

Corvallis, Oregon, 97330, United States

RECRUITING

Oncology Consultants P.A. ( Site 0129)

Houston, Texas, 77030, United States

COMPLETED

Instituto Alexander Fleming ( Site 0306)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

RECRUITING

Hospital Británico de Buenos Aires-Oncology ( Site 0304)

Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

RECRUITING

Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)

Río Cuarto, Córdoba Province, X5800ALB, Argentina

RECRUITING

Instituto de Oncología de Rosario ( Site 0301)

Rosario, Santa Fe Province, S2000KZE, Argentina

RECRUITING

Hospital Aleman-Oncology ( Site 0300)

Buenos Aires, C1118AAT, Argentina

RECRUITING

Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002)

Port Macquarie, New South Wales, 2444, Australia

RECRUITING

Westmead Hospital ( Site 3000)

Westmead, New South Wales, 2145, Australia

RECRUITING

Grampians Health-Medical Oncology ( Site 3001)

Ballarat Central, Victoria, 3350, Australia

COMPLETED

Northern Hospital ( Site 3003)

Epping, Victoria, 3076, Australia

RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0409)

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

RECRUITING

Clinica Viver ( Site 0400)

Santa Maria, Rio Grande do Sul, 97015-450, Brazil

RECRUITING

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0402)

Barretos, São Paulo, 14784400, Brazil

RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0406)

São José do Rio Preto, São Paulo, 15090000, Brazil

RECRUITING

Instituto Nacional de Câncer - INCA ( Site 0405)

Rio de Janeiro, 20230-130, Brazil

RECRUITING

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401)

São Paulo, 04014-012, Brazil

RECRUITING

William Osler Health System ( Site 0203)

Brampton, Ontario, L6R 3J7, Canada

RECRUITING

Trillium Health Partners - Credit Valley Hospital ( Site 0202)

Mississauga, Ontario, L5M 2N1, Canada

RECRUITING

McGill University Health Centre ( Site 0200)

Montreal, Quebec, H4A 3J1, Canada

ACTIVE NOT RECRUITING

Clinica Universidad Catolica del Maule-Oncology ( Site 0501)

Talca, Maule Region, 3465584, Chile

RECRUITING

Orlandi Oncologia-Oncology ( Site 0504)

Santiago, Region M. de Santiago, 7500713, Chile

RECRUITING

FALP-UIDO ( Site 0509)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Bradfordhill-Clinical Area ( Site 0507)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

Bradford Hill Norte ( Site 0516)

Antofagasta, 1263521, Chile

RECRUITING

Second Affiliated hospital of Anhui Medical University ( Site 3133)

Hefei, Anhui, 230000, China

COMPLETED

Beijing Cancer hospital-intrathoratic deparmtment II ( Site 3101)

Beijing, Beijing Municipality, 100142, China

ACTIVE NOT RECRUITING

Beijing Peking Union Medical College Hospital-pneumology department ( Site 3100)

Beijing, Beijing Municipality, 100730, China

RECRUITING

Fujian Provincial Cancer Hospital ( Site 3131)

Fuzhou, Fujian, 350014, China

RECRUITING

The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 3107)

Xiamen, Fujian, 361003, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University ( Site 3134)

Guangzhou, Guangdong, 510140, China

RECRUITING

Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3108)

Guangzhou, Guangdong, 510515, China

RECRUITING

Affiliated Hospital of Guangdong Medical University ( Site 3123)

Zhanjiang, Guangdong, 524004, China

ACTIVE NOT RECRUITING

The Second Hospital of Hebei Medical University ( Site 3135)

Shijiazhuang, Hebei, 050000, China

RECRUITING

Harbin Medical University Cancer Hospital-oncology of department ( Site 3132)

Harbin, Heilongjiang, 150000, China

ACTIVE NOT RECRUITING

Henan Cancer Hospital ( Site 3116)

Zhengzhou, Henan, 450008, China

RECRUITING

Tongji Hospital Tongji Medical,Science & Technology ( Site 3117)

Wuhan, Hubei, 430000, China

ACTIVE NOT RECRUITING

Wuhan Union Hospital ( Site 3130)

Wuhan, Hubei, 430048, China

RECRUITING

Hubei Cancer Hospital ( Site 3106)

Wuhan, Hubei, 430079, China

ACTIVE NOT RECRUITING

Xiangyang Central Hospital-oncology department ( Site 3136)

Xiangyang, Hubei, 441106, China

ACTIVE NOT RECRUITING

The Second Xiangya Hospital of Central South University ( Site 3138)

Changsha, Hunan, 410011, China

RECRUITING

Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3113)

Wuxi, Jiangsu, 214122, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical College ( Site 3112)

Xuzhou, Jiangsu, 221002, China

COMPLETED

The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 3127)

Nanchang, Jiangxi, 330006, China

ACTIVE NOT RECRUITING

The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3121)

Nanchang, Jiangxi, 330006, China

ACTIVE NOT RECRUITING

Jiangxi Provincial Cancer Hospital ( Site 3143)

Nanchang, Jiangxi, 330029, China

ACTIVE NOT RECRUITING

Jilin Province Tumor Hospital-oncology department ( Site 3126)

Changchun, Jilin, 130000, China

ACTIVE NOT RECRUITING

Jinan Central Hospital-oncology department ( Site 3122)

Jinan, Shandong, 250013, China

RECRUITING

Shandong Cancer Hospital ( Site 3119)

Jinan, Shandong, 250117, China

RECRUITING

Shanghai Changhai Hospital ( Site 3125)

Shanghai, Shanghai Municipality, 200082, China

RECRUITING

West China Hospital, Sichuan University ( Site 3124)

Chengdu, Sichuan, 610041, China

RECRUITING

Sichuan Cancer hospital. ( Site 3105)

Chengdu, Sichuan, 610042, China

COMPLETED

The Second People's Hospital of Neijiang ( Site 3140)

Neijiang, Sichuan, 641099, China

RECRUITING

Yunnan Province Cancer Hospital ( Site 3139)

Kunming, Yunnan, 650107, China

RECRUITING

The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)

Hangzhou, Zhejiang, 310003, China

COMPLETED

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3111)

Hangzhou, Zhejiang, 310016, China

RECRUITING

Taizhou Hospital of Zhejiang Province-Respiratory ( Site 3114)

Taizhou, Zhejiang, 317000, China

ACTIVE NOT RECRUITING

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0600)

Bogotá, Bogota D.C., 110131, Colombia

RECRUITING

IMAT S.A.S ( Site 0602)

Montería, Departamento de Córdoba, 230002, Colombia

RECRUITING

Oncologos del Occidente ( Site 0603)

Pereira, Risaralda Department, 660001, Colombia

RECRUITING

Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 1103)

Ostrava, Ostrava Mesto, 703 00, Czechia

RECRUITING

Multiscan-Onkologicke a radiologicke centrum Multiscan Pardubice ( Site 1105)

Pardubice, Pardubice Region, 532 03, Czechia

RECRUITING

Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1106)

Prague, Praha 2, 128 08, Czechia

RECRUITING

Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102)

Olomouc, 779 00, Czechia

RECRUITING

Regionshospitalet Gødstrup-Kræftklinikken ( Site 1204)

Herning, Central Jutland, 7400, Denmark

RECRUITING

Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1201)

Aalborg, North Denmark, 9000, Denmark

RECRUITING

Odense Universitetshospital ( Site 1200)

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Hôpital Saint Joseph-ONCOLOGY ( Site 1308)

Marseille, Bouches-du-Rhone, 13008, France

RECRUITING

Institut Régional du Cancer Montpellier-Medical Oncology ( Site 1309)

Montpellier, Herault, 34298, France

RECRUITING

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 1303)

Limoges, Limousin, 87042, France

RECRUITING

Centre d'Oncologie de Gentilly ( Site 1301)

Nancy, Meurthe-et-Moselle, 54000, France

RECRUITING

Centre Hospitalier de la Côte Basque ( Site 1300)

Bayonne, Pyrenees-Atlantiques, 64109, France

RECRUITING

L HOPITAL NORD OUEST ( Site 1310)

Villefranche-sur-Saône, Rhone, 69655, France

RECRUITING

Clinique de l'Europe-Service de pneumologie ( Site 1304)

Amiens, Somme, 80000, France

RECRUITING

Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1305)

Poitiers, Vienne, 86021, France

RECRUITING

Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik V ( Site 1409)

München, Bavaria, 80336, Germany

RECRUITING

Klinikum Bogenhausen-Klinik für Pneumologie und Onkologische Pneumologie ( Site 1406)

München, Bavaria, 81925, Germany

RECRUITING

Klinikum Nürnberg Nord-5. Med. Klinik ( Site 1407)

Nuremberg, Bavaria, 90419, Germany

RECRUITING

Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 1412)

Marburg, Hesse, 35043, Germany

RECRUITING

Medizinische Hochschule Hannover-Department of Pneumology ( Site 1411)

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Bethanien Krankenhaus Moers ( Site 1400)

Moers, North Rhine-Westphalia, 47441, Germany

RECRUITING

Universitätsklinikum Münster - Albert Schweitzer Campus-Medizinische Klinik A ( Site 1410)

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Universitätsmedizin Johannes Gutenberg Universität Mainz- Klinik für Pneumologie ( Site 1404)

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

LungenClinic Grosshansdorf-Onkologie ( Site 1401)

Großhansdorf, Schleswig-Holstein, 22927, Germany

RECRUITING

SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1403)

Gera, Thuringia, 07548, Germany

RECRUITING

Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1402)

Berlin, 13353, Germany

RECRUITING

Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1804)

Bari, Apulia, 70124, Italy

RECRUITING

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1807)

Meldola, Emilia-Romagna, 47014, Italy

RECRUITING

P.O. "S. Maria della Misericordia" Azienda Sanitaria Univers-Oncology Department ( Site 1803)

Udine, Friuli Venezia Giulia, 33100, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)

Milan, Lombardy, 20133, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1810)

Bergamo, 24127, Italy

RECRUITING

AOU Renato Dulbecco ( Site 1801)

Catanzaro, 88100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Careggi ( Site 1809)

Florence, 50134, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1806)

Roma, 00168, Italy

RECRUITING

Fujita Health University Hospital ( Site 3411)

Toyoake, Aichi-ken, 470-1192, Japan

RECRUITING

Hirosaki University Hospital ( Site 3429)

Hirosaki, Aomori, 036-8563, Japan

RECRUITING

National Cancer Center Hospital East ( Site 3403)

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

National Hospital Organization Shikoku Cancer Center ( Site 3415)

Matsuyama, Ehime, 791-0280, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center ( Site 3417)

Fukuoka, Fukuoka, 811-1395, Japan

RECRUITING

Kurume University Hospital ( Site 3418)

Kurume, Fukuoka, 830-0011, Japan

RECRUITING

Gunma Prefectural Cancer Center ( Site 3402)

Ōta, Gunma, 373-8550, Japan

RECRUITING

National Hospital Organization Himeji Medical Center ( Site 3426)

Himeji, Hyōgo, 670-8520, Japan

RECRUITING

Iwate Medical University Hospital ( Site 3428)

Shiwa-gun, Iwate, 028-3695, Japan

RECRUITING

St. Marianna University Hospital ( Site 3421)

Kawasaki, Kanagawa, 216-8511, Japan

RECRUITING

Yokohama Municipal Citizen's Hospital ( Site 3425)

Yokohama, Kanagawa, 221-0855, Japan

RECRUITING

Kanagawa Cancer Center ( Site 3408)

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Saiseikai Matsusaka Municipal Hospital ( Site 3422)

Matsusaka, Mie-ken, 515-8544, Japan

RECRUITING

Tohoku University Hospital ( Site 3424)

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Sendai Kousei Hospital ( Site 3400)

Sendai, Miyagi, 981-0914, Japan

RECRUITING

Kansai Medical University Hospital ( Site 3412)

Hirakata, Osaka, 573-1191, Japan

RECRUITING

Osaka Medical and Pharmaceutical University Hospital ( Site 3413)

Takatsuki, Osaka, 569-8686, Japan

RECRUITING

National Hospital Organization Ureshino Medical Center ( Site 3427)

Ureshino, Saga-ken, 843-0393, Japan

RECRUITING

Niigata Cancer Center Hospital ( Site 3409)

Niigata, Saitama, 951-8566, Japan

RECRUITING

Shizuoka Cancer Center ( Site 3410)

Suntogun, Shizuoka, 411-8777, Japan

RECRUITING

Dokkyo Medical University Hospital ( Site 3401)

Shimotsugagun, Tochigi, 321-0293, Japan

RECRUITING

Tokyo Metropolitan Komagome Hospital ( Site 3405)

Bunkyo, Tokyo, 113-8677, Japan

RECRUITING

Cancer Institute Hospital of JFCR ( Site 3404)

Koto, Tokyo, 135-8550, Japan

RECRUITING

Toho University Omori Medical Center ( Site 3420)

Ōta-ku, Tokyo, 143-8541, Japan

RECRUITING

Tokyo Medical University Hospital ( Site 3407)

Shinjuku, Tokyo, 160-0023, Japan

RECRUITING

National Center for Global Health and Medicine ( Site 3406)

Shinjuku, Tokyo, 162-8655, Japan

RECRUITING

National Hospital Organization Yamaguchi Ube Medical Center ( Site 3423)

Ube, Yamaguchi, 755-0241, Japan

RECRUITING

National Hospital Organization Kyushu Medical Center ( Site 3416)

Fukuoka, 810-8563, Japan

RECRUITING

Saiseikai Kumamoto Hospital ( Site 3419)

Kumamoto, 861-4193, Japan

RECRUITING

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3414)

Osaka, 541-8567, Japan

RECRUITING

CIO - Centro de Inmuno-Oncología de Occidente ( Site 0715)

Guadalajara, Jalisco, 44630, Mexico

RECRUITING

Higiea Oncologia ( Site 0721)

Mexico City, Mexico City, 11819, Mexico

RECRUITING

Axis Heilsa S. de R.L. de C.V. ( Site 0719)

Monterrey, Nuevo León, 64060, Mexico

COMPLETED

Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0713)

San Luis Potosí City, San Luis Potosí, 78200, Mexico

RECRUITING

Oaxaca Site Management Organization S.C. ( Site 0718)

Oaxaca City, 68000, Mexico

RECRUITING

Clinica Integral Internacional de Oncología ( Site 0714)

Puebla City, 72530, Mexico

RECRUITING

Amphia Ziekenhuis, locatie Breda Molengracht-long oncologie ( Site 1901)

Breda, North Brabant, 4818 CK, Netherlands

RECRUITING

ETZ Elisabeth-Department of Pulmonary Diseases ( Site 1902)

Tilburg, North Brabant, 5022 GC, Netherlands

RECRUITING

Isala, locatie Zwolle-Poli Longziekten ( Site 1903)

Zwolle, Overijssel, 8025 AB, Netherlands

RECRUITING

Clinica Vallesur - AUNA ( Site 0854)

Arequipa, Ariqipa, 15036, Peru

RECRUITING

Detecta Clínica ( Site 0853)

Surquillo, Muni Metro de Lima, 15038, Peru

RECRUITING

IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0851)

Lima, 15036, Peru

RECRUITING

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0850)

Lima, 15038, Peru

RECRUITING

Instituto Neuro Cardiovascular de las Americas ( Site 0856)

Lima, 15047, Peru

RECRUITING

Hospital Cayetano Heredia-Oncology ( Site 0855)

Lima, Lima 31, Peru

RECRUITING

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

RECRUITING

Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 2013)

Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300, Poland

ACTIVE NOT RECRUITING

Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2016)

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

COMPLETED

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 2015)

Krakow, Lesser Poland Voivodeship, 31-826, Poland

RECRUITING

Instytut Gruźlicy i Chorób Płuc w Warszawie-3rd Dep of Lung Diseases and Oncology ( Site 2011)

Warsaw, Masovian Voivodeship, 01-138, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

RECRUITING

Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2018)

Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland

RECRUITING

SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital ( Site 2012)

Lodz, Łódź Voivodeship, 90-549, Poland

RECRUITING

Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 2104)

Lisbon, Lisbon District, 1099-023, Portugal

RECRUITING

Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2101)

Lisbon, Lisbon District, 1769-001, Portugal

RECRUITING

Hospital Dr. Nélio Mendonça ( Site 2105)

Funchal, Madeira, 9004-514, Portugal

RECRUITING

Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 2103)

Vila Nova de Gaia, Porto District, 4434-502, Portugal

RECRUITING

Hospital CUF - Tejo ( Site 2100)

Lisbon, 1350-352, Portugal

RECRUITING

Wonju Severance Christian Hospital ( Site 3808)

Wŏnju, Kang-won-do, 26426, South Korea

COMPLETED

National Cancer Center ( Site 3801)

Goyang-si, Kyonggi-do, 10408, South Korea

RECRUITING

The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3800)

Suwon, Kyonggi-do, 16247, South Korea

RECRUITING

Ajou University Hospital-Hematology-Oncology ( Site 3806)

Suwon, Kyonggi-do, 16499, South Korea

COMPLETED

Chungbuk National University Hospital-Internal medicine ( Site 3804)

Cheongju-si, North Chungcheong, 28644, South Korea

RECRUITING

Keimyung University Dongsan Hospital CRC room 1 ( Site 3807)

Daegu, Taegu-Kwangyokshi, 42601, South Korea

RECRUITING

Asan Medical Center-Lung Cancer Center ( Site 3805)

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center-Division of Hematology/Oncology ( Site 3802)

Seoul, 06351, South Korea

RECRUITING

Hospital Jerez de la Frontera-UGC Oncología ( Site 2333)

Jerez de la Frontera, Cadiz, 11407, Spain

RECRUITING

CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2335)

A Coruña, La Coruna, 15006, Spain

RECRUITING

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2331)

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

H.R.U Malaga - Hospital General ( Site 2332)

Málaga, Malaga, 29011, Spain

RECRUITING

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2336)

Valencia, Valenciana, Comunitat, 46009, Spain

RECRUITING

Hospital Universitari Vall d'Hebron-Oncology ( Site 2330)

Barcelona, 08035, Spain

RECRUITING

Hospital La Princesa ( Site 2338)

Madrid, 28006, Spain

RECRUITING

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2337)

Seville, 41013, Spain

RECRUITING

Chi Mei Hospital - Liouying Branch ( Site 3908)

Tainan, Tainan, 73657, Taiwan

RECRUITING

National Taiwan University Cancer Center (NTUCC) ( Site 3907)

Taipei City, Taipei, 106, Taiwan

RECRUITING

National Taiwan University Hospital - Hsinchu branch ( Site 3901)

Hsinchu, 300, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3904)

Kaohsiung City, 807, Taiwan

COMPLETED

Chang Gung Memorial Hospital at Kaohsiung ( Site 3902)

Kaohsiung City, 83301, Taiwan

RECRUITING

Taipei Medical University Shuang Ho Hospital ( Site 3912)

New Taipei City, 23561, Taiwan

RECRUITING

Taichung Veterans General Hospital-Chest ( Site 3905)

Taichung, 40705, Taiwan

ACTIVE NOT RECRUITING

National Cheng Kung University Hospital-Clinical Trial Center ( Site 3903)

Tainan, 704, Taiwan

RECRUITING

Chi Mei Medical Center ( Site 3915)

Tainan, 71004, Taiwan

RECRUITING

National Taiwan University Hospital-Oncology ( Site 3906)

Taipei, 10002, Taiwan

RECRUITING

Mackay Memorial Hospital ( Site 3909)

Taipei, 10449, Taiwan

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 4000)

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Chulalongkorn University ( Site 4003)

Pathumwan, Bangkok, 10330, Thailand

RECRUITING

Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 4001)

Chiang Mai, 50200, Thailand

RECRUITING

Medipol Mega Universite Hastanesi-oncology ( Site 2508)

Stanbul, Istanbul, 34214, Turkey (Türkiye)

RECRUITING

Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2503)

Bornova, İzmir, 35100, Turkey (Türkiye)

RECRUITING

Erciyes University ( Site 2511)

Talas, Kayseri, 38039, Turkey (Türkiye)

RECRUITING

Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2507)

Adana, 01140, Turkey (Türkiye)

RECRUITING

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2506)

Ankara, 06200, Turkey (Türkiye)

RECRUITING

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501)

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Memorial Ankara Hastanesi-Medical Oncology ( Site 2505)

Ankara, 06520, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Şehir Hastanesi ( Site 2500)

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre-Oncolgyy-Hematology ( Site 2510)

Denizli, 20070, Turkey (Türkiye)

RECRUITING

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)

Istanbul, 34722, Turkey (Türkiye)

RECRUITING

Ondokuz Mayıs Universitesi ( Site 2509)

Samsun, 55139, Turkey (Türkiye)

RECRUITING

Royal Free Hospital ( Site 2601)

London, England, NW3 2QG, United Kingdom

RECRUITING

Queen Alexandra Hospital-Oncology Department ( Site 2603)

Portsmouth, Hampshire, PO6 3LY, United Kingdom

RECRUITING

Kent and Canterbury Hospital-Oncology Research ( Site 2606)

Canterbury, Kent, CT1 3NG, United Kingdom

RECRUITING

Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2605)

London, London, City of, SE1 9RT, United Kingdom

RECRUITING

James Cook University Hospital ( Site 2604)

Central Middlesbrough, Middlesbrough, TS4 3BW, United Kingdom

RECRUITING

National Lung Hospital-Oncology Department ( Site 4175)

Hanoi, Hanoi, 100000, Vietnam

RECRUITING

Tam Anh General Hospital ( Site 4179)

Hanoi, Hanoi, 100000, Vietnam

RECRUITING

Cho Ray Hospital ( Site 4171)

Ho Chi Minh, Hanoi, 700000, Vietnam

RECRUITING

K Hospital - National Cancer Hospital ( Site 4174)

Hà Nội, 100000, Vietnam

RECRUITING

Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 4173)

Ho Chi Minh City, 700000, Vietnam

RECRUITING

Thong Nhat Hospital ( Site 4170)

Ho Chi Minh City, 700000, Vietnam

ACTIVE NOT RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 14, 2023
• Study Start: December 15, 2023
• Primary Completion (Estimated): January 25, 2028
• Study Completion (Estimated): May 27, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

ME (6); VN (6); CN (32); PL (9); KR (8); CZ (4); DE (11); IT (8); JP (30); PT (5); ES (8); PE (6); AU (4); FR (8); TW (11); DK (3); TH (3); AR (5); CO (3); NL (3); TU (11); GB (5); BR (6); CA (3); CL (5); US (15)