AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3KEYVIBE-006NCT05298423

Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006)

A Phase 3 study testing pembrolizumab/vibostolimab, durvalumab and cisplatin in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 160 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
pembrolizumab/vibostolimab, durvalumab and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
610 participants
Where
160 sitesin 25 countries
Study dates
3 May 2022to 15 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

160 sites in 25 countries.

160 sites in 25 countries

China28 sites

  • Beijing Cancer hospital-intrathoratic deparmtment II ( Site 0328)

    Beijing, Beijing Municipality, 100142

  • Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 0309)

    Beijing, Beijing Municipality, 100142

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

    Beijing, Beijing Municipality, 100730

  • Jilin Cancer Hospital-oncology department ( Site 0319)

    Changchun, Jilin, 130012

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

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 0307)

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University ( Site 0324)

    Chengdu, Sichuan, 610041

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

    Chongqing, Chongqing Municipality, 400042

  • Fujian Provincial Cancer Hospital ( Site 0316)

    Fuzhou, Fujian, 350014

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

    Fuzhou Fujian, Fujian, 350001

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

    Guangzhou, Guangdong, 510515

  • Hangzhou Cancer Hospital-Medical Oncology ( Site 0302)

    Hangzhou, Zhejiang, 310002

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

    Hangzhou, Zhejiang, 310009

  • Zhejiang Cancer Hospital ( Site 0308)

    Hangzhou, Zhejiang, 310022

  • Shandong Provincial Hospital ( Site 0326)

    Jinan, Shandong, 250001

  • Qingdao Central Hospital-Endocrinology ( Site 0332)

    Qingdao, Shandong, 266042

  • Shanghai Chest Hospital-Radiotherapy Department ( Site 0306)

    Shanghai, Shanghai Municipality, 200030

  • Fudan University Shanghai Cancer Center ( Site 0304)

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Pulmonary Hospital-Radiotherapy department ( Site 0335)

    Shanghai, Shanghai Municipality, 200433

  • Fourth Hospital of Hebei Medical University ( Site 0331)

    Shijiazhuang, Hebei, 050035

  • The Second Affiliated Hospital of Soochow University ( Site 0314)

    Suzhou, Jiangsu, 215004

  • Shanxi Cancer Hospital-Pulmonology ( Site 0322)

    Taiyuan, Shanxi, 030000

  • Tianjin Cancer Hospital ( Site 0329)

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430000

  • Hubei Cancer Hospital ( Site 0311)

    Wuhan, Hubei, 430079

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

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital ( Site 0333)

    Zhengzhou, Henan, 450008

  • Affiliated Hospital of Jiangsu University ( Site 0305)

    Zhenjiang, Jiangsu, 212001

Other trials in China

United States21 sites

  • MFSMC-HJWCI ( Site 2804)

    Baltimore, Maryland, 21237

  • Boston Medical Center ( Site 2829)

    Boston, Massachusetts, 02118

  • University of Chicago Medical Center ( Site 2828)

    Chicago, Illinois, 60637

  • University of Missouri Hospital ( Site 2839)

    Columbia, Missouri, 65212

  • Millennium Oncology Research Clinic ( Site 2801)

    Hollywood, Florida, 33024

  • Millennium Research & Clinical Development ( Site 2811)

    Houston, Texas, 77090

  • Franciscan St. Francis Health ( Site 2812)

    Indianapolis, Indiana, 46237

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

    Lancaster, Pennsylvania, 17601

  • VA Long Beach Healthcare System ( Site 2831)

    Long Beach, California, 90822

  • VA West Los Angeles Medical Center ( Site 2808)

    Los Angeles, California, 90073

  • Rutgers Cancer Institute of New Jersey ( Site 2805)

    New Brunswick, New Jersey, 08901

  • Icahn School of Medicine at Mount Sinai ( Site 2821)

    New York, New York, 10029

  • Mid Florida Hematology and Oncology Center ( Site 2800)

    Orange City, Florida, 32763

  • Thomas Jefferson University - Clinical Research Institute ( Site 2813)

    Philadelphia, Pennsylvania, 19107

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

    Portland, Oregon, 97227

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

    Springfield, Missouri, 65807

  • MultiCare Health System ( Site 2817)

    Tacoma, Washington, 98405

  • Moffitt Cancer Center ( Site 2818)

    Tampa, Florida, 33612

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

    Temple, Texas, 76504

  • White Plains Hospital ( Site 2835)

    White Plains, New York, 10601

  • University of Massachusetts Chan Medical School ( Site 2815)

    Worcester, Massachusetts, 01655

Other trials in United States

Japan13 sites

  • Kansai Medical University Hospital ( Site 1207)

    Hirakata, Osaka, 573-1191

  • Saitama Prefectural Cancer Center ( Site 1201)

    Ina-machi, Saitama, 362-0806

  • Kobe Minimally Invasive Cancer Center ( Site 1210)

    Kobe, Hyōgo, 650-0046

  • Cancer Institute Hospital of JFCR ( Site 1202)

    Koto, Tokyo, 135-8550

  • Kurume University Hospital ( Site 1212)

    Kurume, Fukuoka, 830-0011

  • National Hospital Organization Shikoku Cancer Center ( Site 1211)

    Matsuyama, Ehime, 791-0280

  • Miyagi Cancer Center ( Site 1200)

    Natori-shi, Miyagi, 981-1293

  • Niigata Cancer Center Hospital ( Site 1205)

    Niigata, Niigata, 951-8566

  • Osaka International Cancer Institute ( Site 1209)

    Osaka, 541-8567

  • Sendai Kousei Hospital ( Site 1213)

    Sendai, Miyagi, 981-0914

  • Showa Medical University Hospital ( Site 1203)

    Shinagawa, Tokyo, 142-8666

  • Osaka Medical and Pharmaceutical University Hospital ( Site 1208)

    Takatsuki, Osaka, 569-8686

  • Kanagawa Cancer Center ( Site 1204)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Turkey (Türkiye)9 sites

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

    Adana, 01250

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

    Ankara, 06010

  • Hacettepe Universitesi-oncology hospital ( Site 2605)

    Ankara, 06230

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 2609)

    Ankara, 06520

  • Ankara City Hospital-Medical Oncology ( Site 2601)

    Ankara, 06800

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

    Bornova, İzmir, 35100

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

    Istanbul, 34722

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

    Izmir, 35575

  • Medipol Mega Universite Hastanesi-oncology ( Site 2611)

    Stanbul, Istanbul, 34214

Other trials in Turkey (Türkiye)

Greece7 sites

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

    Athens, Attica, 115 26

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

    Athens, Attica, 115 28

  • Sotiria Thoracic Diseases Hospital of Athens ( Site 0704)

    Athens, Attica, 11527

  • Metropolitan Hospital ( Site 0702)

    Athens, Attica, 185 47

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

    Heraklion, Irakleio, 715 00

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

    Nea Kifissia, Attica, 136 77

  • European Interbalkan Medical Center ( Site 0701)

    Thessaloniki, 570 01

Other trials in Greece

Italy7 sites

  • Azienda Ospedaliera Spedali Civili di Brescia ( Site 1105)

    Brescia, 25123

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1100)

    Milan, Lombardy, 20133

  • Ospedale San Raffaele. ( Site 1104)

    Milan, 20132

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

    Monza, Lombardy, 20900

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

    Naples, Campania, 80131

  • Fondazione IRCCS Policlinico San Matteo ( Site 1103)

    Pavia, 27100

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

    Rome, Lazio, 00128

Other trials in Italy

Chile6 sites

  • Biocenter ( Site 0208)

    Concepción, Biobio, 4070196

  • FALP-UIDO ( Site 0205)

    Santiago, Region M. de Santiago, 7500921

  • Centro de Oncología de Precisión ( Site 0209)

    Santiago, Region M. de Santiago, 7560908

  • Bradfordhill ( Site 0200)

    Santiago, Region M. de Santiago, 8420383

  • James Lind Centro de Investigacion del Cancer ( Site 0202)

    Temuco, Araucania, 4800827

  • ONCOCENTRO APYS-ACEREY ( Site 0203)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Romania6 sites

  • Centrul Medical Medicover Victoria ( Site 2106)

    Bucharest, Bucharest, 010626

  • Centrul Medical Neolife- Baneasa ( Site 2110)

    Bucharest, 077190

  • Centrul de Oncologie "Sfântul Nectarie" ( Site 2100)

    Craiova, Dolj, 200542

  • Amethyst Radiotherapy Center ( Site 2102)

    Florești, Cluj, 407280

  • Radiology Therapeutic Center ( Site 2108)

    Otopeni, Ilfov, 075100

  • Cabinet Medical Oncomed ( Site 2101)

    Timișoara, Timiș County, 300239

Other trials in Romania

Ukraine6 sites

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

    Kropyvnytskyi, Kirovohrad Oblast, 25011

  • Universal Clinic Oberig-Oncology Center ( Site 2916)

    Kyiv, 03057

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

    Lutsk, Volyn Oblast, 43018

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

    Lviv, Lviv Oblast, 79059

  • Rivne Regional Clinical Hospital ( Site 2919)

    Rivne, Rivne Oblast, 33007

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

    Vinnytsia, Vinnytsia Oblast, 21029

Other trials in Ukraine

Australia5 sites

  • Ballarat Health Services-Medical Oncology ( Site 0002)

    Ballarat Central, Victoria, 3350

  • Canberra Hospital ( Site 0010)

    Canberra, Australian Capital Territory, 2605

  • Frankston Hospital-Oncology and Haematology ( Site 0009)

    Frankston, Victoria, 3199

  • Icon Cancer Centre Hobart ( Site 0003)

    Hobart, Tasmania, 7000

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

    Melbourne, Victoria, 3065

Other trials in Australia

Israel5 sites

  • Rambam Health Care Campus-Oncology ( Site 1001)

    Haifa, 3109601

  • Shaare Zedek Medical Center ( Site 1003)

    Jerusalem, 9103102

  • Rabin Medical Center ( Site 1004)

    Petah Tikva, 4941492

  • Sheba Medical Center-ONCOLOGY ( Site 1000)

    Ramat Gan, 5265601

  • Sourasky Medical Center ( Site 1002)

    Tel Aviv, 6423906

Other trials in Israel

South Africa5 sites

  • Cape Town Oncology Trials ( Site 2306)

    Cape Town, Western Cape, 7570

  • The Oncology Centre ( Site 2300)

    Durban, KwaZulu-Natal, 4091

  • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2304)

    Port Elizabeth, Eastern Cape, 6055

  • Wilgers Oncology Centre ( Site 2301)

    Pretoria, Gauteng, 0040

  • Abraham Oncology ( Site 2303)

    Richards Bay, KwaZulu-Natal, 3900

Other trials in South Africa

Germany4 sites

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

    Berlin, 13353

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

    Chemnitz, Saxony, 09116

  • LungenClinic Grosshansdorf-Onkologie ( Site 0602)

    Großhansdorf, Schleswig-Holstein, 22927

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

    Kiel, Schleswig-Holstein, 24105

Other trials in Germany

Guatemala4 sites

  • MEDI-K ( Site 0807)

    Guatemala City, 01009

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

    Guatemala City, 01010

  • Centro Regional de Sub Especialidades Médicas SA ( Site 0801)

    Quetzaltenango, 09001

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

    Quetzaltenango, 09002

Other trials in Guatemala

Mexico4 sites

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

    Chihuahua City, 31217

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

    Guadalajara, Jalisco, 44680

  • Arké SMO S.A. de C.V. ( Site 1504)

    Mexico City, Mexico City, 06700

  • Centro de Investigacion Clinica de Oaxaca ( Site 1501)

    Oaxaca City, 68020

Other trials in Mexico

Portugal4 sites

  • Champalimaud Foundation ( Site 2003)

    Lisbon, Lisbon District, 1400-038

  • Hospital CUF Descobertas ( Site 2006)

    Lisbon, Lisbon District, 1998-018

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

    Porto, 4099-001

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

    Porto, 4200-072

Other trials in Portugal

South Korea4 sites

  • Chungbuk National University Hospital-Internal medicine ( Site 2400)

    Cheongju-si, North Chungcheong, 28644

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

    Seoul, 03722

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

    Suwon, Kyonggi-do, 16247

  • Ajou University Hospital-Hematology-Oncology ( Site 2402)

    Suwon, Kyonggi-do, 16499

Other trials in South Korea

Spain4 sites

  • Hospital Universitari Vall d'Hebron ( Site 2501)

    Barcelona, Catalonia, 08035

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

    Barcelona, Catalonia, 08036

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2504)

    Pozuelo de Alarcón, Madrid, Comunidad de, 28223

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

    Santiago de Compostela, La Coruna, 15706

Other trials in Spain

Argentina3 sites

  • Clinica Adventista Belgrano ( Site 3601)

    Caba., Buenos Aires F.D., C1430EGF

  • Instituto Médico Río Cuarto ( Site 3600)

    Río Cuarto, Córdoba Province, X5800

  • Sanatorio Parque ( Site 3602)

    Rosario, Santa Fe Province, S2000DSV

Other trials in Argentina

Brazil3 sites

  • Hospital Nossa Senhora da Conceição ( Site 0111)

    Porto Alegre, Rio Grande do Sul, 91350-200

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

    Rio de Janeiro, 22793-080

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

    São Paulo, 01509-010

Other trials in Brazil

Costa Rica3 sites

  • CIMCA ( Site 0501)

    San José, Provincia de San José, 10103

  • PROCLINICAL Pharma ( Site 0504)

    San José, Provincia de San José, 11303

  • Hospital Metropolitano - Sede Lindora ( Site 0503)

    Santa Ana, Provincia de San José, 10903

Other trials in Costa Rica

Malaysia3 sites

  • Hospital Pulau Pinang ( Site 1400)

    George Town, Pulau Pinang, 10450

  • Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1401)

    Kuala Lumpur, 50586

  • University Malaya Medical Centre-Clinical Oncology ( Site 1402)

    Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

Czechia2 sites

  • Masarykuv onkologicky ustav ( Site 3500)

    Brno, Brno-mesto, 656 53

  • Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 3502)

    Ostrava, Moravian-Silesian Region, 708 52

Other trials in Czechia

Dominican Republic2 sites

  • Onconet ( Site 3002)

    Distrito Nacional, Santo Domingo Province, 10148

  • Instituto de Oncologia ( Site 3003)

    Santo Domingo, Nacional, 10102

Other trials in Dominican Republic

Philippines2 sites

  • THE MEDICAL CITY-Cancer Research Center ( Site 3200)

    Pasig, National Capital Region, 1605

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

    Quezon City, National Capital Region, 1100

Other trials in Philippines

About this study

Official title: Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC

Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.

Read the detailed description

As of protocol amendment 4, participants receiving combination vibostolimab and pembrolizumab (MK-7684A) discontinued treatment due to lack of efficacy observed in other MK-7684A studies, and are given the option to transition to durvalumab therapy.

Being tested
pembrolizumab/vibostolimab, durvalumab, cisplatin, pemetrexed, etoposide
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pembrolizumab/vibostolimabBiological

    Also called MK-7684A

    Administered as an intravenous (IV) infusion

  • durvalumabBiological

    Also called IMFINZI®

    Administered as an IV infusion

  • cisplatinDrug

    Also called PLATINOL-AQ®

    Cisplatin 75 mg/m^2 administered as an IV infusion in combination with pemetrexed on Day 1 of Cycles 1-3 for non-squamous histology only; In combination with etoposide, cisplatin 50 mg/m^2 is administered on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3

  • pemetrexedDrug

    Also called ALIMTA®

    Pemetrexed 500 mg/m^2 administered as an IV infusion on Day 1 of Cycles 1-3 for non-squamous histology only

  • etoposideDrug

    Also called TOPOSAR®

    Etoposide 50 mg/m^2 is administered as an IV infusion on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3;

  • carboplatinDrug

    Also called PARAPLATIN®

    Carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion

  • paclitaxelDrug

    Also called TAXOL®

    Paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion

  • thoracic radiotherapyRadiation

    60 Gray [Gy] in 2 Gy fractions for 30 days total administered as an external beam radiation

Study groups in NCT05298423
Study groupRoleWhat they receive
pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapyExperimentalFor the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to ~14 months). Cycles 1-20 are 21-day cycles. As of protocol amendment 4, participants receiving pembrolizumab/vibostolimab must stop ongoing treatment with pembrolizumab/vibostolimab and will be offered the option to transition to post-cCRT durvalumab consolidation therapy, to complete up to 1 year of consolidation immunotherapy.
Receives: Biological: pembrolizumab/vibostolimab; Biological: durvalumab; Drug: cisplatin; Drug: pemetrexed; Drug: etoposide; Drug: carboplatin; Drug: paclitaxel; Radiation: thoracic radiotherapy
chemotherapy+radiotherapy+durvalumabActive comparatorFor the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy during Cycles 2 and 3. Following concurrent chemoradiotherapy (cCRT), participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles.
Receives: Biological: durvalumab; Drug: cisplatin; Drug: pemetrexed; Drug: etoposide; Drug: carboplatin; Drug: paclitaxel; Radiation: thoracic radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experience at Least One Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 48 months

  2. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study start3 May 2022
  3. Primary completion15 Jun 2026
  4. Study completion15 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
610 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05298423
Sponsor's protocol ID
7684A-006
Other IDs
MK-7684A-006, KEYVIBE-006, jRCT2021220015, PHRR230831-006071, 2022-502752-31-00, U1111-1285-3656, 2021-005135-23
Acronym
KEYVIBE-006
Status last verified
Jul 2026
First submitted
17 Mar 2022
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pembrolizumab/vibostolimab, durvalumab and cisplatin in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 160 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 160 sites in China, United States, Japan, Turkey (Türkiye), Greece and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience at Least One Adverse Event (AE) (time frame: Up to approximately 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05298423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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