Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus... | NCT05298423 | Trialant

Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus... | NCT05298423 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria

Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.

Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8

Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon

Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain

Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review

Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC

Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional])

Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention

Has a life expectancy of at least 6 months

Exclusion Criteria

Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible

Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer

Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention

Is expected to require any other form of antineoplastic therapy, while on study

Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention

Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Is 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

Has a 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 prior to the first dose of study medication

Has a known additional malignancy that is progressing or has required active treatment within the past 5 years

Has an active autoimmune disease that has required systemic treatment in past 2 years

Has a 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) infection

Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection

Has had an allogenic tissue/solid organ transplant

Pemetrexed-specific Criteria:

Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed

Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

VA Long Beach Healthcare System ( Site 2831)

Long Beach, California 90822, United States

VA West Los Angeles Medical Center ( Site 2808)

Los Angeles, California 90073, United States

Millennium Oncology Research Clinic ( Site 2801)

Hollywood, Florida 33024, United States

Mid Florida Hematology and Oncology Center ( Site 2800)

Orange City, Florida 32763, United States

Moffitt Cancer Center ( Site 2818)

Tampa, Florida 33612, United States

University of Chicago Medical Center ( Site 2828)

Chicago, Illinois 60637, United States

Franciscan St. Francis Health ( Site 2812)

Indianapolis, Indiana 46237, United States

MFSMC-HJWCI ( Site 2804)

Baltimore, Maryland 21237, United States

Boston Medical Center ( Site 2829)

Boston, Massachusetts 02118, United States

University of Massachusetts Chan Medical School ( Site 2815)

Worcester, Massachusetts 01655, United States

University of Missouri Hospital ( Site 2839)

Columbia, Missouri 65212, United States

Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 2837)

Springfield, Missouri 65807, United States

Rutgers Cancer Institute of New Jersey ( Site 2805)

New Brunswick, New Jersey 08901, United States

Icahn School of Medicine at Mount Sinai ( Site 2821)

New York, New York 10029, United States

White Plains Hospital ( Site 2835)

White Plains, New York 10601, United States

Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 2816)

Portland, Oregon 97227, United States

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 2827)

Lancaster, Pennsylvania 17601, United States

Thomas Jefferson University - Clinical Research Institute ( Site 2813)

Philadelphia, Pennsylvania 19107, United States

Millennium Research & Clinical Development ( Site 2811)

Houston, Texas 77090, United States

Central Texas Veterans health care-Oncology & Hematology ( Site 2819)

Temple, Texas 76504, United States

MultiCare Health System ( Site 2817)

Tacoma, Washington 98405, United States

Clinica Adventista Belgrano ( Site 3601)

Caba., Buenos Aires F.D. C1430EGF, Argentina

Instituto Médico Río Cuarto ( Site 3600)

Río Cuarto, Córdoba Province X5800, Argentina

Sanatorio Parque ( Site 3602)

Rosario, Santa Fe Province S2000DSV, Argentina

Canberra Hospital ( Site 0010)

Canberra, Australian Capital Territory 2605, Australia

Icon Cancer Centre Hobart ( Site 0003)

Hobart, Tasmania 7000, Australia

Ballarat Health Services-Medical Oncology ( Site 0002)

Ballarat Central, Victoria 3350, Australia

Frankston Hospital-Oncology and Haematology ( Site 0009)

Frankston, Victoria 3199, Australia

St Vincent's Hospital-Oncology Clinical Trials ( Site 0005)

Melbourne, Victoria 3065, Australia

Hospital Nossa Senhora da Conceição ( Site 0111)

Porto Alegre, Rio Grande do Sul 91350-200, Brazil

Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0105)

Rio de Janeiro, 22793-080, Brazil

A. C. Camargo Cancer Center-CAPEC ( Site 0102)

São Paulo, 01509-010, Brazil

James Lind Centro de Investigacion del Cancer ( Site 0202)

Temuco, Araucania 4800827, Chile

Biocenter ( Site 0208)

Concepción, Biobio 4070196, Chile

FALP-UIDO ( Site 0205)

Santiago, Region M. de Santiago 7500921, Chile

Centro de Oncología de Precisión ( Site 0209)

Santiago, Region M. de Santiago 7560908, Chile

Bradfordhill ( Site 0200)

Santiago, Region M. de Santiago 8420383, Chile

ONCOCENTRO APYS-ACEREY ( Site 0203)

Viña del Mar, Valparaiso 2520598, Chile

Beijing Cancer hospital-intrathoratic deparmtment II ( Site 0328)

Beijing, Beijing Municipality 100142, China

Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 0309)

Beijing, Beijing Municipality 100142, China

Beijing Peking Union Medical College Hospital-pneumology department ( Site 0300)

Beijing, Beijing Municipality 100730, China

Army Medical Center of People's Liberation Army-Oncology Department ( Site 0321)

Chongqing, Chongqing Municipality 400042, China

Fujian Provincial Cancer Hospital ( Site 0316)

Fuzhou, Fujian 350014, China

Fujian Medical University Union Hospital-1 Bingfanglou ( Site 0330)

Fuzhou Fujian, Fujian 350001, China

The First Affiliated hospital of Xiamen University-oncology ( Site 0317)

Xiamen, Fujian 361003, China

Southern Medical University Nanfang Hospital-Department of Oncology ( Site 0336)

Guangzhou, Guangdong 510515, China

Fourth Hospital of Hebei Medical University ( Site 0331)

Shijiazhuang, Hebei 050035, China

Henan Cancer Hospital ( Site 0333)

Zhengzhou, Henan 450008, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0315)

Wuhan, Hubei 430000, China

Hubei Cancer Hospital ( Site 0311)

Wuhan, Hubei 430079, China

Xiangya Hospital Central South University-Oncology department ( Site 0310)

Changsha, Hunan 410008, China

Hunan Cancer Hospital ( Site 0307)

Changsha, Hunan 410013, China

The Second Affiliated Hospital of Soochow University ( Site 0314)

Suzhou, Jiangsu 215004, China

Affiliated Hospital of Jiangsu University ( Site 0305)

Zhenjiang, Jiangsu 212001, China

Jilin Cancer Hospital-oncology department ( Site 0319)

Changchun, Jilin 130012, China

Shandong Provincial Hospital ( Site 0326)

Jinan, Shandong 250001, China

Qingdao Central Hospital-Endocrinology ( Site 0332)

Qingdao, Shandong 266042, China

Shanghai Chest Hospital-Radiotherapy Department ( Site 0306)

Shanghai, Shanghai Municipality 200030, China

Fudan University Shanghai Cancer Center ( Site 0304)

Shanghai, Shanghai Municipality 200032, China

Shanghai Pulmonary Hospital-Radiotherapy department ( Site 0335)

Shanghai, Shanghai Municipality 200433, China

Shanxi Cancer Hospital-Pulmonology ( Site 0322)

Taiyuan, Shanxi 030000, China

West China Hospital of Sichuan University ( Site 0324)

Chengdu, Sichuan 610041, China

Tianjin Cancer Hospital ( Site 0329)

Tianjin, Tianjin Municipality 300060, China

Hangzhou Cancer Hospital-Medical Oncology ( Site 0302)

Hangzhou, Zhejiang 310002, China

The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0301)

Hangzhou, Zhejiang 310009, China

Zhejiang Cancer Hospital ( Site 0308)

Hangzhou, Zhejiang 310022, China

CIMCA ( Site 0501)

San José, Provincia de San José 10103, Costa Rica

PROCLINICAL Pharma ( Site 0504)

San José, Provincia de San José 11303, Costa Rica

Hospital Metropolitano - Sede Lindora ( Site 0503)

Santa Ana, Provincia de San José 10903, Costa Rica

Masarykuv onkologicky ustav ( Site 3500)

Brno, Brno-mesto 656 53, Czechia

Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 3502)

Ostrava, Moravian-Silesian Region 708 52, Czechia

Instituto de Oncologia ( Site 3003)

Santo Domingo, Nacional 10102, Dominican Republic

Onconet ( Site 3002)

Distrito Nacional, Santo Domingo Province 10148, Dominican Republic

Klinikum Chemnitz-Klinik für Innere Medizin IV ( Site 0607)

Chemnitz, Saxony 09116, Germany

LungenClinic Grosshansdorf-Onkologie ( Site 0602)

Großhansdorf, Schleswig-Holstein 22927, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel-Medizinische Klinik II, Hämatologie und Onkolo ( Site 0609)

Kiel, Schleswig-Holstein 24105, Germany

Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0603)

Berlin, 13353, Germany

Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 0703)

Athens, Attica 115 26, Greece

Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0706)

Athens, Attica 115 28, Greece

Sotiria Thoracic Diseases Hospital of Athens ( Site 0704)

Athens, Attica 11527, Greece

Metropolitan Hospital ( Site 0702)

Athens, Attica 185 47, Greece

General Oncology Hospital of Kifissia "Agioi Anargiroi"-2nd Department of Medical Oncology ( Site 0705)

Nea Kifissia, Attica 136 77, Greece

University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0700)

Heraklion, Irakleio 715 00, Greece

European Interbalkan Medical Center ( Site 0701)

Thessaloniki, 570 01, Greece

MEDI-K ( Site 0807)

Guatemala City, 01009, Guatemala

Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0802)

Guatemala City, 01010, Guatemala

Centro Regional de Sub Especialidades Médicas SA ( Site 0801)

Quetzaltenango, 09001, Guatemala

Centro Medico Integral De Cancerología (CEMIC) ( Site 0805)

Quetzaltenango, 09002, Guatemala

Rambam Health Care Campus-Oncology ( Site 1001)

Haifa, 3109601, Israel

Shaare Zedek Medical Center ( Site 1003)

Jerusalem, 9103102, Israel

Rabin Medical Center ( Site 1004)

Petah Tikva, 4941492, Israel

Sheba Medical Center-ONCOLOGY ( Site 1000)

Ramat Gan, 5265601, Israel

Sourasky Medical Center ( Site 1002)

Tel Aviv, 6423906, Israel

Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia medica Toraco-Polmonare ( Site 1107)

Naples, Campania 80131, Italy

Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 1101)

Rome, Lazio 00128, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1100)

Milan, Lombardy 20133, Italy

Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1102)

Monza, Lombardy 20900, Italy

Azienda Ospedaliera Spedali Civili di Brescia ( Site 1105)

Brescia, 25123, Italy

Ospedale San Raffaele. ( Site 1104)

Milan, 20132, Italy

Fondazione IRCCS Policlinico San Matteo ( Site 1103)

Pavia, 27100, Italy

National Hospital Organization Shikoku Cancer Center ( Site 1211)

Matsuyama, Ehime 791-0280, Japan

Kurume University Hospital ( Site 1212)

Kurume, Fukuoka 830-0011, Japan

Kobe Minimally Invasive Cancer Center ( Site 1210)

Kobe, Hyōgo 650-0046, Japan

Kanagawa Cancer Center ( Site 1204)

Yokohama, Kanagawa 241-8515, Japan

Miyagi Cancer Center ( Site 1200)

Natori-shi, Miyagi 981-1293, Japan

Sendai Kousei Hospital ( Site 1213)

Sendai, Miyagi 981-0914, Japan

Niigata Cancer Center Hospital ( Site 1205)

Niigata, Niigata 951-8566, Japan

Kansai Medical University Hospital ( Site 1207)

Hirakata, Osaka 573-1191, Japan

Osaka Medical and Pharmaceutical University Hospital ( Site 1208)

Takatsuki, Osaka 569-8686, Japan

Saitama Prefectural Cancer Center ( Site 1201)

Ina-machi, Saitama 362-0806, Japan

Cancer Institute Hospital of JFCR ( Site 1202)

Koto, Tokyo 135-8550, Japan

Showa Medical University Hospital ( Site 1203)

Shinagawa, Tokyo 142-8666, Japan

Osaka International Cancer Institute ( Site 1209)

Osaka, 541-8567, Japan

University Malaya Medical Centre-Clinical Oncology ( Site 1402)

Lembah Pantai, Kuala Lumpur 59100, Malaysia

Hospital Pulau Pinang ( Site 1400)

George Town, Pulau Pinang 10450, Malaysia

Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1401)

Kuala Lumpur, 50586, Malaysia

Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 1505)

Guadalajara, Jalisco 44680, Mexico

Arké SMO S.A. de C.V. ( Site 1504)

Mexico City, Mexico City 06700, Mexico

Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 1507)

Chihuahua City, 31217, Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 1501)

Oaxaca City, 68020, Mexico

THE MEDICAL CITY-Cancer Research Center ( Site 3200)

Pasig, National Capital Region 1605, Philippines

Veterans Memorial Medical Center-Section of Oncology ( Site 3201)

Quezon City, National Capital Region 1100, Philippines

Champalimaud Foundation ( Site 2003)

Lisbon, Lisbon District 1400-038, Portugal

Hospital CUF Descobertas ( Site 2006)

Lisbon, Lisbon District 1998-018, Portugal

Unidade Local de Saude de Santo António - Hospital Santo António ( Site 2004)

Porto, 4099-001, Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2001)

Porto, 4200-072, Portugal

Centrul Medical Medicover Victoria ( Site 2106)

Bucharest, Bucharest 010626, Romania

Amethyst Radiotherapy Center ( Site 2102)

Florești, Cluj 407280, Romania

Centrul de Oncologie "Sfântul Nectarie" ( Site 2100)

Craiova, Dolj 200542, Romania

Radiology Therapeutic Center ( Site 2108)

Otopeni, Ilfov 075100, Romania

Cabinet Medical Oncomed ( Site 2101)

Timișoara, Timiș County 300239, Romania

Centrul Medical Neolife- Baneasa ( Site 2110)

Bucharest, 077190, Romania

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2304)

Port Elizabeth, Eastern Cape 6055, South Africa

Wilgers Oncology Centre ( Site 2301)

Pretoria, Gauteng 0040, South Africa

The Oncology Centre ( Site 2300)

Durban, KwaZulu-Natal 4091, South Africa

Abraham Oncology ( Site 2303)

Richards Bay, KwaZulu-Natal 3900, South Africa

Cape Town Oncology Trials ( Site 2306)

Cape Town, Western Cape 7570, South Africa

The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2401)

Suwon, Kyonggi-do 16247, South Korea

Ajou University Hospital-Hematology-Oncology ( Site 2402)

Suwon, Kyonggi-do 16499, South Korea

Chungbuk National University Hospital-Internal medicine ( Site 2400)

Cheongju-si, North Chungcheong 28644, South Korea

Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 2403)

Seoul, 03722, South Korea

Hospital Universitari Vall d'Hebron ( Site 2501)

Barcelona, Catalonia 08035, Spain

HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2503)

Barcelona, Catalonia 08036, Spain

CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2502)

Santiago de Compostela, La Coruna 15706, Spain

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2504)

Pozuelo de Alarcón, Madrid, Comunidad de 28223, Spain

Medipol Mega Universite Hastanesi-oncology ( Site 2611)

Stanbul, Istanbul 34214, Turkey (Türkiye)

Ege University Medicine of Faculty-Chest Diseases Department ( Site 2603)

Bornova, İzmir 35100, Turkey (Türkiye)

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2607)

Adana, 01250, Turkey (Türkiye)

Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 2602)

Ankara, 06010, Turkey (Türkiye)

Hacettepe Universitesi-oncology hospital ( Site 2605)

Ankara, 06230, Turkey (Türkiye)

Memorial Ankara Hastanesi-Medical Oncology ( Site 2609)

Ankara, 06520, Turkey (Türkiye)

Ankara City Hospital-Medical Oncology ( Site 2601)

Ankara, 06800, Turkey (Türkiye)

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2610)

Istanbul, 34722, Turkey (Türkiye)

I.E.U. Medical Point Hastanesi-Oncology ( Site 2612)

Izmir, 35575, Turkey (Türkiye)

Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 2905)

Kropyvnytskyi, Kirovohrad Oblast 25011, Ukraine

Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital ( Site 2920)

Lviv, Lviv Oblast 79059, Ukraine

Rivne Regional Clinical Hospital ( Site 2919)

Rivne, Rivne Oblast 33007, Ukraine

Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2900)

Vinnytsia, Vinnytsia Oblast 21029, Ukraine

Volyn Regional clinical hospital. Regional Medical Oncology Centre. Oncology chemotherapy department ( Site 2918)

Lutsk, Volyn Oblast 43018, Ukraine

Universal Clinic Oberig-Oncology Center ( Site 2916)

Kyiv, 03057, Ukraine