Lung Cancer Clinical Trial

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/KEYVIBE-006)

Summary

This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following:

progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants.
overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

784

Study ID:

NCT05298423

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 54 Locations for this study

See Locations Near You

Millennium Oncology Research Clinic ( Site 2801)
Hollywood Florida, 33024, United States More Info
Study Coordinator
Contact
954-450-1808
Mid Florida Hematology and Oncology Center ( Site 2800)
Orange City Florida, 32763, United States More Info
Study Coordinator
Contact
386-774-1223
MFSMC-HJWCI ( Site 2804)
Baltimore Maryland, 21237, United States More Info
Study Coordinator
Contact
443-777-7147
Rutgers Cancer Institute of New Jersey ( Site 2805)
New Brunswick New Jersey, 08903, United States More Info
Study Coordinator
Contact
732-235-2465
Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 2816)
Portland Oregon, 97227, United States More Info
Study Coordinator
Contact
503-335-2400
Thomas Jefferson University - Clinical Research Institute ( Site 2813)
Philadelphia Pennsylvania, 19107, United States More Info
Study Coordinator
Contact
215-834-4387
Central Texas Veterans health care-Oncology & Hematology ( Site 2819)
Temple Texas, 76504, United States More Info
Study Coordinator
Contact
254-743-0204
Icon Cancer Centre Hobart ( Site 0003)
Hobart Tasmania, 7000, Australia More Info
Study Coordinator
Contact
0437636224
Ballarat Health Services-Medical Oncology ( Site 0002)
Ballarat Central Victoria, 3350, Australia More Info
Study Coordinator
Contact
0413578465
Frankston Hospital-Oncology and Haematology ( Site 0009)
Frankston Victoria, 3199, Australia More Info
Study Coordinator
Contact
(03) 9784 7071
St Vincent's Hospital-Oncology Clinical Trials ( Site 0005)
Melbourne Victoria, 3065, Australia More Info
Study Coordinator
Contact
61392313167
A. C. Camargo Cancer Center-CAPEC ( Site 0102)
Sao Paulo , 01509, Brazil More Info
Study Coordinator
Contact
+551121895021
James Lind Centro de Investigación del Cáncer ( Site 0202)
Temuco Araucania, 47800, Chile More Info
Study Coordinator
Contact
+56452982404
Biocenter ( Site 0208)
Concepción Biobio, 40701, Chile More Info
Study Coordinator
Contact
+56974779078
FALP-UIDO ( Site 0205)
Santiago Region M. De Santiago, 69009, Chile More Info
Study Coordinator
Contact
+56981369487
Centro de Oncología de Precisión ( Site 0209)
Santiago Region M. De Santiago, 75609, Chile More Info
Study Coordinator
Contact
+56991612199
Bradfordhill ( Site 0200)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
+56998744662
ONCOCENTRO APYS-ACEREY ( Site 0203)
Viña del Mar Valparaiso, 25205, Chile More Info
Study Coordinator
Contact
+56322323980
Beijing Peking Union Medical College Hospital-pneumology department ( Site 0300)
Beijing Beijing, 10073, China More Info
Study Coordinator
Contact
13911235467
Southern Medical University Nanfang Hospital-Department of Oncology ( Site 0336)
Guangzhou Guangdong, 51051, China More Info
Study Coordinator
Contact
020-62787730
Henan Cancer Hospital ( Site 0333)
Zhengzhou Henan, 45000, China More Info
Study Coordinator
Contact
13607695140
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0315)
Wuhan Hubei, 43002, China More Info
Study Coordinator
Contact
+86 027-85726300
Hubei Cancer Hospital ( Site 0311)
Wuhan Hubei, 43007, China More Info
Study Coordinator
Contact
+86 027-87670318
Xiangya Hospital Central South University-Oncology department ( Site 0310)
Changsha Hunan, 41000, China More Info
Study Coordinator
Contact
13875898127
Hunan Cancer Hospital ( Site 0307)
Changsha Hunan, 41001, China More Info
Study Coordinator
Contact
0731-89762231
Shanghai Chest Hospital-Radiotherapy Department ( Site 0306)
Shanghai Shanghai, 20003, China More Info
Study Coordinator
Contact
13651635103
CIMCA ( Site 0501)
San José San Jose, 10103, Costa Rica More Info
Study Coordinator
Contact
+50683893636
Hospital Metropolitano - Sede Lindora ( Site 0503)
Santa Ana San Jose, 10903, Costa Rica More Info
Study Coordinator
Contact
+5064035 1212
Klinikum Chemnitz-Klinik für Innere Medizin IV ( Site 0607)
Chemnitz Sachsen, 09116, Germany More Info
Study Coordinator
Contact
+4937133343072
LungenClinic Grosshansdorf-Onkologie ( Site 0602)
Grosshansdorf Schleswig-Holstein, 22927, Germany More Info
Study Coordinator
Contact
+4941026012101
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0802)
Ciudad de Guatemala , 01010, Guatemala More Info
Study Coordinator
Contact
+502 30635474
Centro Regional de Sub Especialidades Médicas SA ( Site 0801)
Quetzaltenango , 09001, Guatemala More Info
Study Coordinator
Contact
+502 59450559
Centro Medico Integral De Cancerología (CEMIC) ( Site 0805)
Quetzaltenango , 09002, Guatemala More Info
Study Coordinator
Contact
+502 59458053
Rambam Health Care Campus-Oncology ( Site 1001)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
972-4-7776412
Sheba Medical Center-ONCOLOGY ( Site 1000)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
97235307096
Sourasky Medical Center ( Site 1002)
Tel Aviv , 64239, Israel More Info
Study Coordinator
Contact
+972 36973494
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1100)
Milan Lombardia, 20133, Italy More Info
Study Coordinator
Contact
390223902190
Kansai Medical University Hospital ( Site 1207)
Hirakata Osaka, 573-1, Japan More Info
Study Coordinator
Contact
+81-72-804-0101
Saitama Prefectural Cancer Center ( Site 1201)
Ina-machi Saitama, 362-0, Japan More Info
Study Coordinator
Contact
+81-48-722-1111
Japanese Foundation for Cancer Research ( Site 1202)
Koto Tokyo, 135-8, Japan More Info
Study Coordinator
Contact
+81-3-3520-0111
Showa University Hospital ( Site 1203)
Shinagawa Tokyo, 14286, Japan More Info
Study Coordinator
Contact
+81-3-3784-8000
Chungbuk National University Hospital-Internal medicine ( Site 2400)
Cheongju-si Chungbuk, 28644, Korea, Republic of More Info
Study Coordinator
Contact
82432696898
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2401)
Suwon-si Kyonggi-do, 16247, Korea, Republic of More Info
Study Coordinator
Contact
82312498485
Ajou University Hospital-Hematology-Oncology ( Site 2402)
Suwon-si Kyonggi-do, 16499, Korea, Republic of More Info
Study Coordinator
Contact
820312194266
Arké SMO S.A. de C.V. ( Site 1504)
Mexico Distrito Federal, 06700, Mexico More Info
Study Coordinator
Contact
55 55115833
Centro de Investigacion Clinica de Oaxaca ( Site 1501)
Oaxaca , 68020, Mexico More Info
Study Coordinator
Contact
9516035559
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
Barcelona Cataluna, 08036, Spain More Info
Study Coordinator
Contact
+34932275402
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2502)
Santiago de Compostela La Coruna, 15706, Spain More Info
Study Coordinator
Contact
981950511
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2504)
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Study Coordinator
Contact
0034914521987
Hospital Universitari Vall d'Hebron ( Site 2501)
Barcelona , 08035, Spain More Info
Study Coordinator
Contact
+34932746085
Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 2602)
Ankara , 06010, Turkey More Info
Study Coordinator
Contact
(0312) 042000
Hacettepe Universitesi-oncology hospital ( Site 2605)
Ankara , 06230, Turkey More Info
Study Coordinator
Contact
+903123053432
Memorial Ankara Hastanesi-Medical Oncology ( Site 2609)
Ankara , 06520, Turkey More Info
Study Coordinator
Contact
+903122536666
Ankara City Hospital-Medical Oncology ( Site 2601)
Ankara , 06800, Turkey More Info
Study Coordinator
Contact
+903125526000

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

784

Study ID:

NCT05298423

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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